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Trial record 1 of 1 for:    22436213 [PUBMED-IDS]
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Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

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ClinicalTrials.gov Identifier: NCT02114892
Recruitment Status : Completed
First Posted : April 15, 2014
Results First Posted : December 29, 2014
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Manuel González Ortiz, University of Guadalajara

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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Resveratrol Placebo
Hide 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
Arm/Group Title Resveratrol Placebo Total
Hide 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
Hide 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)]
1.Primary Outcome
Title Triglycerides Levels at Week 12
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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.
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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.
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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]
Time Frame Adverse events were collected throughout the study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Resveratrol Placebo
Hide 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   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Resveratrol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide 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
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
Publications of Results:
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