Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition	Metabolic Syndrome X
Interventions	Drug: Resveratrol; Drug: Placebo
Enrollment	24

Participant Flow

Go to 

Top of Page Participant Flow Baseline Characteristics Outcome Measures Adverse Events Limitations and Caveats Information More Information

Recruitment Details
Pre-assignment Details

Arm/Group Title	Resveratrol	Placebo
Arm/Group Description	Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Period Title: Overall Study
Started	12	12
Completed	11 [1]	10 [2]
Not Completed	1	2
Reason Not Completed
Lost to Follow-up	1	2
[1] One patient did not complete the study due to early withdrawl; [2] Two patients did not complete the study due to early withdrawl

Baseline Characteristics

Go to 

Top of Page Participant Flow Baseline Characteristics Outcome Measures Adverse Events Limitations and Caveats Information More Information

Arm/Group Title		Resveratrol	Placebo	Total
Arm/Group Description		Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg	Total of all reporting groups
Overall Number of Baseline Participants		12	12	24
Baseline Analysis Population Description		Sample size was calculated in accordance of Jeyaseelan’s clinical trial formula with a statistical confidence of 95%, statistical power of 80%, obtaining a total of 12 patients per group including 20% of expected loss.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	12 participants	12 participants	24 participants
		39.75 (5.38)	40.33 (5.41)	40.04 (5.29)
Gender; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	12 participants	24 participants
	Female	10 83.3%	7 58.3%	17 70.8%
	Male	2 16.7%	5 41.7%	7 29.2%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	12 participants	24 participants
	Hispanic or Latino	12 100.0%	12 100.0%	24 100.0%
	Not Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Mexico	Number Analyzed	12 participants	12 participants	24 participants
		12	12	24
Body weight [1]; Mean (Standard Deviation); Unit of measure: Kg
	Number Analyzed	12 participants	12 participants	24 participants
		94.4 (13.2)	91.0 (10.7)	92.71 (11.90)
		[1] Measure Description: Body weight was evaluated through a bioimpedance digital scale and results are reported in kg with a decimal.
Height [1]; Mean (Standard Deviation); Unit of measure: Cm
	Number Analyzed	12 participants	12 participants	24 participants
		162.67 (7.2)	164.33 (7.2)	163.50 (7.1)
		[1] Measure Description: Height was measured with subjects standing and the measurements were round to the nearest centimeter.
Body mass index (BMI); Mean (Standard Deviation); Unit of measure: Kg/m2
	Number Analyzed	12 participants	12 participants	24 participants
		35.56 (3.2)	33.73 (3.7)	34.65 (3.5)
Fat Mass [1]; Mean (Standard Deviation); Unit of measure: Kg
	Number Analyzed	12 participants	12 participants	24 participants
		41.18 (7.9)	36.13 (9.2)	38.66 (8.8)
		[1] Measure Description: Fat mass was evaluated through a bioimpedance digital scale and results are reported in kg with a decimal
Waist circumference [1]; Mean (Standard Deviation); Unit of measure: Cm
	Number Analyzed	12 participants	12 participants	24 participants
		109.83 (9.3)	104.50 (8.5)	107.17 (9.1)
		[1] Measure Description: Waist circumference was measured with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.
Systolic blood pressure [1]; Mean (Standard Deviation); Unit of measure: mmHg
	Number Analyzed	12 participants	12 participants	24 participants
		119.96 (13.1)	116.03 (13.2)	117.99 (13.0)
		[1] Measure Description: Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure (SBP) and diastolic (DBP). The value was expressed on mmHg
Diastolic blood pressure [1]; Mean (Standard Deviation); Unit of measure: mmHg
	Number Analyzed	12 participants	12 participants	24 participants
		78.36 (8.7)	77.15 (8.4)	77.76 (8.4)
		[1] Measure Description: Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure (SBP) and diastolic (DBP). The value was expressed on mmHg
Glucose 0' [1]; Mean (Standard Deviation); Unit of measure: Mmol/l
	Number Analyzed	12 participants	12 participants	24 participants
		4.8 (0.6)	5.1 (0.4)	4.95 (0.5)
		[1] Measure Description: The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2500 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
Glucose 30' [1]; Mean (Standard Deviation); Unit of measure: Mmol/l
	Number Analyzed	12 participants	12 participants	24 participants
		8.5 (1.8)	8.4 (1.1)	8.4 (1.4)
		[1] Measure Description: The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
Glucose 60' [1]; Mean (Standard Deviation); Unit of measure: Mmol/l
	Number Analyzed	12 participants	12 participants	24 participants
		9.0 (2.7)	9.3 (1.8)	9.1 (2.2)
		[1] Measure Description: The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
Glucose 90' [1]; Mean (Standard Deviation); Unit of measure: Mmol/l
	Number Analyzed	12 participants	12 participants	24 participants
		8.3 (2.3)	8.0 (1.8)	8.2 (2.0)
		[1] Measure Description: The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
Glucose 120' [1]; Mean (Standard Deviation); Unit of measure: Mmol/l
	Number Analyzed	12 participants	12 participants	24 participants
		6.5 (1.7)	6.9 (2.2)	6.7 (1.9)
		[1] Measure Description: The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
Cholesterol [1]; Mean (Standard Deviation); Unit of measure: mg/dL
	Number Analyzed	12 participants	12 participants	24 participants
		206.0 (32.0)	195.4 (34.8)	200.7 (33.1)
		[1] Measure Description: The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
Triglycerides [1]; Mean (Standard Deviation); Unit of measure: mg/dL
	Number Analyzed	12 participants	12 participants	24 participants
		254.3 (55.6)	233.8 (77.7)	244.0 (66.9)
		[1] Measure Description: The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
HDL-c [1]; Mean (Standard Deviation); Unit of measure: mg/dL
	Number Analyzed	12 participants	12 participants	24 participants
		37.3 (3.7)	37.9 (7.7)	37.6 (5.9)
		[1] Measure Description: The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
LDL-c [1]; Mean (Standard Deviation); Unit of measure: mg/dL
	Number Analyzed	12 participants	12 participants	24 participants
		120.7 (32.0)	119.8 (46.5)	120.2 (39.0)
		[1] Measure Description: The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
AUC glucose [1]; Mean (Standard Deviation); Unit of measure: mmol*h/L
	Number Analyzed	12 participants	12 participants	24 participants
		935.8 (188.6)	950.8 (167.6)	943.3 (174.6)
		[1] Measure Description: Area under the curve (AUC) of glucose and insulin was calculated with the polygonal formula.
AUC insuline [1]; Mean (Standard Deviation); Unit of measure: pmol*h/L
	Number Analyzed	12 participants	12 participants	24 participants
		48418.5 (22707.4)	62955.8 (37620.0)	55687.1 (31282.6)
		[1] Measure Description: Area under the curve (AUC) of glucose and insulin was calculated with the polygonal formula.
Total insulin secretion [1]; Mean (Standard Deviation); Unit of measure: Unitless
	Number Analyzed	12 participants	12 participants	24 participants
		0.48 (0.22)	0.59 (0.29)	0.54 (0.26)
		[1] Measure Description: Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose).
First phase of insulin secretion [1]; Mean (Standard Deviation); Unit of measure: Unitless
	Number Analyzed	12 participants	12 participants	24 participants
		1256.6 (601.5)	1440.0 (619.8)	1348.3 (604.6)
		[1] Measure Description: First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30’ – 138.7 x glucose 30’ + 3.772 x insulin 0’)
Insulin sensitivity [1]; Mean (Standard Deviation); Unit of measure: Unitless
	Number Analyzed	12 participants	12 participants	24 participants
		3.5 (1.5)	3.3 (1.5)	3.4 (1.4)
		[1] Measure Description: Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0’ x insulin 0’) (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]

Outcome Measures

Go to 

Top of Page Participant Flow Baseline Characteristics Outcome Measures Adverse Events Limitations and Caveats Information More Information

1. Primary Outcome

Title	Triglycerides Levels at Week 12
Description	The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Arm/Group Title	Resveratrol	Placebo
Arm/Group Description:	Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Overall Number of Participants Analyzed	11	10
Mean (Standard Deviation); Unit of Measure: mg/dL
	210.6 (63.3)	235.8 (148.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.131
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

2. Primary Outcome

Title	High Density Lipoprotein (c-HDL) Levels at Week 12.
Description	The c-HDL levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Arm/Group Title	Resveratrol	Placebo
Arm/Group Description:	Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Overall Number of Participants Analyzed	11	10
Mean (Standard Deviation); Unit of Measure: mg/dL
	37.6 (5.0)	41.1 (8.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.859
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

3. Primary Outcome

Title	Fasting Glucose Levels at Week 12.
Description	The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Arm/Group Title	Resveratrol	Placebo
Arm/Group Description:	Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Overall Number of Participants Analyzed	11	10
Mean (Standard Deviation); Unit of Measure: mmol/L
	4.6 (0.6)	4.5 (0.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.070
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

4. Primary Outcome

Title	Systolic Blood Pressure at Week 12.
Description	The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Arm/Group Title	Resveratrol	Placebo
Arm/Group Description:	Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Overall Number of Participants Analyzed	11	10
Mean (Standard Deviation); Unit of Measure: mmHg
	116.1 (11.3)	121.7 (11.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.338
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

5. Primary Outcome

Title	First Phase of Insulin Secretion at Week 12.
Description	The first phase of insulin secretion was calculated at baseline and week 12 with Stumvoll index and the entered values reflect the first phase of insulin secretion at week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Arm/Group Title	Resveratrol	Placebo
Arm/Group Description:	Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Overall Number of Participants Analyzed	11	10
Mean (Standard Deviation); Unit of Measure: unitless
	1019.7 (335.1)	1279.3 (599.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.278
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

6. Primary Outcome

Title	Total Insulin Secretion at Week 12.
Description	The total insulin secretion was calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Arm/Group Title	Resveratrol	Placebo
Arm/Group Description:	Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Overall Number of Participants Analyzed	11	10
Mean (Standard Deviation); Unit of Measure: unitless
	.28 (0.08)	.60 (0.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.01
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

7. Primary Outcome

Title	Total Insulin Sensitivity at Week 12.
Description	The insulin sensitivity was calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Arm/Group Title	Resveratrol	Placebo
Arm/Group Description:	Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Overall Number of Participants Analyzed	11	10
Mean (Standard Deviation); Unit of Measure: unitless
	4.2 (1.2)	4.7 (2.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.083
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

8. Primary Outcome

Title	Waist Circumference at Week 12
Description	Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Arm/Group Title	Resveratrol	Placebo
Arm/Group Description:	Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Overall Number of Participants Analyzed	11	10
Mean (Standard Deviation); Unit of Measure: cm
	105.4 (10.7)	105.8 (7.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.01
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

9. Primary Outcome

Title	Diastolic Blood Pressure at Week 12
Description	The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Arm/Group Title	Resveratrol	Placebo
Arm/Group Description:	Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Overall Number of Participants Analyzed	11	10
Mean (Standard Deviation); Unit of Measure: mmHg
	78.1 (9.2)	78.9 (7.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.672
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

10. Secondary Outcome

Title	Weight at Week 12.
Description	The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Arm/Group Title	Resveratrol	Placebo
Arm/Group Description:	Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Overall Number of Participants Analyzed	11	10
Mean (Standard Deviation); Unit of Measure: kg
	90.5 (12.3)	93.1 (9.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.01
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

11. Secondary Outcome

Title	Body Mass Index at Week 12
Description	The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Arm/Group Title	Resveratrol	Placebo
Arm/Group Description:	Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Overall Number of Participants Analyzed	11	10
Mean (Standard Deviation); Unit of Measure: kg/m2
	34.3 (3.0)	34.0 (3.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.01
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

12. Secondary Outcome

Title	Total Cholesterol at Week 12
Description	The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Arm/Group Title	Resveratrol	Placebo
Arm/Group Description:	Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Overall Number of Participants Analyzed	11	10
Mean (Standard Deviation); Unit of Measure: mg/dL
	203.4 (38.0)	208.9 (27.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.946
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

13. Secondary Outcome

Title	Low Density Lipoproteins (c-LDL) at Week 12
Description	The c-LDL levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Arm/Group Title	Resveratrol	Placebo
Arm/Group Description:	Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Overall Number of Participants Analyzed	11	10
Mean (Standard Deviation); Unit of Measure: mg/dL
	122.3 (39.2)	126.8 (33.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.365
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

14. Secondary Outcome

Title	Creatinine at Week 12.
Description	The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12
Time Frame	Baseline. Week 12.

Outcome Measure Data

Analysis Population Description

All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Arm/Group Title	Resveratrol	Placebo
Arm/Group Description:	Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Overall Number of Participants Analyzed	11	10
Mean (Standard Deviation); Unit of Measure: µmol/l
	57.94 (14.20)	63.29 (11.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.557
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

15. Secondary Outcome

Title	Uric Acid at Week 12.
Description	The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12
Time Frame	Week 12.

Outcome Measure Data

Analysis Population Description

All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Arm/Group Title	Resveratrol	Placebo
Arm/Group Description:	Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.	Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Overall Number of Participants Analyzed	11	10
Mean (Standard Deviation); Unit of Measure: µmol/l
	277.93 (38.72)	364.03 (67.95)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Resveratrol, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.01
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Adverse Events

Go to 

Top of Page Participant Flow Baseline Characteristics Outcome Measures Adverse Events Limitations and Caveats Information More Information

Time Frame	Adverse events were collected throughout the study
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Resveratrol		Placebo
Arm/Group Description	Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.		Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
All-Cause Mortality
	Resveratrol		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Resveratrol		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0.00%)		0/12 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Resveratrol		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/12 (41.67%)		4/12 (33.33%)
Blood and lymphatic system disorders
Nosebleed * 1	0/12 (0.00%)	0	1/12 (8.33%)	1
Gastrointestinal disorders
Abdominal pain * 1	1/12 (8.33%)	1	1/12 (8.33%)	1
Sickness * 1	1/12 (8.33%)	1	0/12 (0.00%)	0
Constipation * 1	0/12 (0.00%)	0	1/12 (8.33%)	1
Flatulence * 1	0/12 (0.00%)	0	1/12 (8.33%)	1
Nervous system disorders
Headache * 1	3/12 (25.00%)	3	1/12 (8.33%)	1
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, ANY

Limitations and Caveats

Go to 

Top of Page Participant Flow Baseline Characteristics Outcome Measures Adverse Events Limitations and Caveats Information More Information

[Not Specified]

More Information

Go to 

Top of Page Participant Flow Baseline Characteristics Outcome Measures Adverse Events Limitations and Caveats Information More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title: Dr. Manuel González Ortiz

Organization: Institute of Experimental andl Clinical Therapeutics

Phone: +52-33-10-58-52-00 ext 34212

EMail: uiec@prodigy.net.mx

Publications of Results:

Zhang J. Resveratrol inhibits insulin responses in a SirT1-independent pathway. Biochem J. 2006 Aug 1;397(3):519-27.

Rivera L, Morón R, Zarzuelo A, Galisteo M. Long-term resveratrol administration reduces metabolic disturbances and lowers blood pressure in obese Zucker rats. Biochem Pharmacol. 2009 Mar 15;77(6):1053-63. doi: 10.1016/j.bcp.2008.11.027. Epub 2008 Dec 3.

Hung LM, Chen JK, Huang SS, Lee RS, Su MJ. Cardioprotective effect of resveratrol, a natural antioxidant derived from grapes. Cardiovasc Res. 2000 Aug 18;47(3):549-55.

Yu C, Shin YG, Chow A, Li Y, Kosmeder JW, Lee YS, Hirschelman WH, Pezzuto JM, Mehta RG, van Breemen RB. Human, rat, and mouse metabolism of resveratrol. Pharm Res. 2002 Dec;19(12):1907-14.

Walle T, Hsieh F, DeLegge MH, Oatis JE Jr, Walle UK. High absorption but very low bioavailability of oral resveratrol in humans. Drug Metab Dispos. 2004 Dec;32(12):1377-82. Epub 2004 Aug 27.

Aumont V, Krisa S, Battaglia E, Netter P, Richard T, Mérillon JM, Magdalou J, Sabolovic N. Regioselective and stereospecific glucuronidation of trans- and cis-resveratrol in human. Arch Biochem Biophys. 2001 Sep 15;393(2):281-9.

Smoliga JM, Baur JA, Hausenblas HA. Resveratrol and health--a comprehensive review of human clinical trials. Mol Nutr Food Res. 2011 Aug;55(8):1129-41. doi: 10.1002/mnfr.201100143. Epub 2011 Jun 20. Review.

Baur JA, Pearson KJ, Price NL, Jamieson HA, Lerin C, Kalra A, Prabhu VV, Allard JS, Lopez-Lluch G, Lewis K, Pistell PJ, Poosala S, Becker KG, Boss O, Gwinn D, Wang M, Ramaswamy S, Fishbein KW, Spencer RG, Lakatta EG, Le Couteur D, Shaw RJ, Navas P, Puigserver P, Ingram DK, de Cabo R, Sinclair DA. Resveratrol improves health and survival of mice on a high-calorie diet. Nature. 2006 Nov 16;444(7117):337-42. Epub 2006 Nov 1.

Fischer-Posovszky P, Kukulus V, Tews D, Unterkircher T, Debatin KM, Fulda S, Wabitsch M. Resveratrol regulates human adipocyte number and function in a Sirt1-dependent manner. Am J Clin Nutr. 2010 Jul;92(1):5-15. doi: 10.3945/ajcn.2009.28435. Epub 2010 May 12.

Baile CA, Yang JY, Rayalam S, Hartzell DL, Lai CY, Andersen C, Della-Fera MA. Effect of resveratrol on fat mobilization. Ann N Y Acad Sci. 2011 Jan;1215:40-7. doi: 10.1111/j.1749-6632.2010.05845.x. Review.

Alberdi G, Rodríguez VM, Miranda J, Macarulla MT, Arias N, Andrés-Lacueva C, Portillo MP. Changes in white adipose tissue metabolism induced by resveratrol in rats. Nutr Metab (Lond). 2011 May 10;8(1):29. doi: 10.1186/1743-7075-8-29.

Bruckbauer A, Zemel MB, Thorpe T, Akula MR, Stuckey AC, Osborne D, Martin EB, Kennel S, Wall JS. Synergistic effects of leucine and resveratrol on insulin sensitivity and fat metabolism in adipocytes and mice. Nutr Metab (Lond). 2012 Aug 22;9(1):77. doi: 10.1186/1743-7075-9-77.

Ramadori G, Gautron L, Fujikawa T, Vianna CR, Elmquist JK, Coppari R. Central administration of resveratrol improves diet-induced diabetes. Endocrinology. 2009 Dec;150(12):5326-33. doi: 10.1210/en.2009-0528. Epub 2009 Oct 9.

Szkudelski T. Resveratrol-induced inhibition of insulin secretion from rat pancreatic islets: evidence for pivotal role of metabolic disturbances. Am J Physiol Endocrinol Metab. 2007 Oct;293(4):E901-7. Epub 2007 Jun 19.

Lagouge M, Argmann C, Gerhart-Hines Z, Meziane H, Lerin C, Daussin F, Messadeq N, Milne J, Lambert P, Elliott P, Geny B, Laakso M, Puigserver P, Auwerx J. Resveratrol improves mitochondrial function and protects against metabolic disease by activating SIRT1 and PGC-1alpha. Cell. 2006 Dec 15;127(6):1109-22. Epub 2006 Nov 16.

Penumathsa SV, Thirunavukkarasu M, Zhan L, Maulik G, Menon VP, Bagchi D, Maulik N. Resveratrol enhances GLUT-4 translocation to the caveolar lipid raft fractions through AMPK/Akt/eNOS signalling pathway in diabetic myocardium. J Cell Mol Med. 2008 Dec;12(6A):2350-61. doi: 10.1111/j.1582-4934.2008.00251.x. Erratum in: J Cell Mol Med. 2010 Oct;14(10):2539.

Dao TM, Waget A, Klopp P, Serino M, Vachoux C, Pechere L, Drucker DJ, Champion S, Barthélemy S, Barra Y, Burcelin R, Sérée E. Resveratrol increases glucose induced GLP-1 secretion in mice: a mechanism which contributes to the glycemic control. PLoS One. 2011;6(6):e20700. doi: 10.1371/journal.pone.0020700. Epub 2011 Jun 6.

Brasnyó P, Molnár GA, Mohás M, Markó L, Laczy B, Cseh J, Mikolás E, Szijártó IA, Mérei A, Halmai R, Mészáros LG, Sümegi B, Wittmann I. Resveratrol improves insulin sensitivity, reduces oxidative stress and activates the Akt pathway in type 2 diabetic patients. Br J Nutr. 2011 Aug;106(3):383-9. doi: 10.1017/S0007114511000316. Epub 2011 Mar 9.

Crandall JP, Oram V, Trandafirescu G, Reid M, Kishore P, Hawkins M, Cohen HW, Barzilai N. Pilot study of resveratrol in older adults with impaired glucose tolerance. J Gerontol A Biol Sci Med Sci. 2012 Dec;67(12):1307-12. doi: 10.1093/gerona/glr235. Epub 2012 Jan 4.

Szkudelski T. Resveratrol inhibits insulin secretion from rat pancreatic islets. Eur J Pharmacol. 2006 Dec 15;552(1-3):176-81. Epub 2006 Sep 27.

Other Publications:

Beaudeux JL, Nivet-Antoine V, Giral P. Resveratrol: a relevant pharmacological approach for the treatment of metabolic syndrome? Curr Opin Clin Nutr Metab Care. 2010 Nov;13(6):729-36. doi: 10.1097/MCO.0b013e32833ef291. Review.

Szkudelska K, Szkudelski T. Resveratrol, obesity and diabetes. Eur J Pharmacol. 2010 Jun 10;635(1-3):1-8. doi: 10.1016/j.ejphar.2010.02.054. Epub 2010 Mar 19. Review.

Baur JA, Sinclair DA. Therapeutic potential of resveratrol: the in vivo evidence. Nat Rev Drug Discov. 2006 Jun;5(6):493-506. Epub 2006 May 26. Review.

Timmers S, Auwerx J, Schrauwen P. The journey of resveratrol from yeast to human. Aging (Albany NY). 2012 Mar;4(3):146-58. Review.

Kroon PA, Iyer A, Chunduri P, Chan V, Brown L. The Cardiovascular Nutrapharmacology of Resveratrol: Pharmacokinetics, Molecular Mechanisms and Therapeutic Potential. Curr Med Chem. 2010;17(23):2442-55. Review.

Baur JA. Resveratrol, sirtuins, and the promise of a DR mimetic. Mech Ageing Dev. 2010 Apr;131(4):261-9. doi: 10.1016/j.mad.2010.02.007. Epub 2010 Feb 26. Review.

Szkudelski T, Szkudelska K. Anti-diabetic effects of resveratrol. Ann N Y Acad Sci. 2011 Jan;1215:34-9. doi: 10.1111/j.1749-6632.2010.05844.x. Review.

Responsible Party:	Manuel González Ortiz, University of Guadalajara
ClinicalTrials.gov Identifier:	NCT02114892 History of Changes
Other Study ID Numbers:	RESV-MS
First Submitted:	April 11, 2014
First Posted:	April 15, 2014
Results First Submitted:	December 2, 2014
Results First Posted:	December 29, 2014
Last Update Posted:	December 7, 2016