Trial record 5 of 112 for:    resveratrol

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Manuel González Ortiz, University of Guadalajara
ClinicalTrials.gov Identifier:
NCT02114892
First received: April 11, 2014
Last updated: December 16, 2014
Last verified: December 2014
Results First Received: December 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Metabolic Syndrome X
Interventions: Drug: Resveratrol
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Resveratrol

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.

Placebo

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


Participant Flow:   Overall Study
    Resveratrol     Placebo  
STARTED     12     12  
COMPLETED     11 [1]   10 [2]
NOT COMPLETED     1     2  
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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Resveratrol

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.

Placebo

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 Total of all reporting groups

Baseline Measures
    Resveratrol     Placebo     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: years]
Mean (Standard Deviation)
  39.75  (5.38)     40.33  (5.41)     40.04  (5.29)  
Gender  
[units: participants]
     
Female     10     7     17  
Male     2     5     7  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     12     12     24  
Not Hispanic or Latino     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
Mexico     12     12     24  
Body weight [1]
[units: kg]
Mean (Standard Deviation)
  94.4  (13.2)     91.0  (10.7)     92.71  (11.90)  
Height [2]
[units: cm]
Mean (Standard Deviation)
  162.67  (7.2)     164.33  (7.2)     163.50  (7.1)  
Body mass index (BMI)  
[units: kg/m2]
Mean (Standard Deviation)
  35.56  (3.2)     33.73  (3.7)     34.65  (3.5)  
Fat Mass [3]
[units: kg]
Mean (Standard Deviation)
  41.18  (7.9)     36.13  (9.2)     38.66  (8.8)  
Waist circumference [4]
[units: cm]
Mean (Standard Deviation)
  109.83  (9.3)     104.50  (8.5)     107.17  (9.1)  
Systolic blood pressure [5]
[units: mmHg]
Mean (Standard Deviation)
  119.96  (13.1)     116.03  (13.2)     117.99  (13.0)  
Diastolic blood pressure [5]
[units: mmHg]
Mean (Standard Deviation)
  78.36  (8.7)     77.15  (8.4)     77.76  (8.4)  
Glucose 0' [6]
[units: mmol/l]
Mean (Standard Deviation)
  4.8  (0.6)     5.1  (0.4)     4.95  (0.5)  
Glucose 30' [7]
[units: mmol/l]
Mean (Standard Deviation)
  8.5  (1.8)     8.4  (1.1)     8.4  (1.4)  
Glucose 60' [7]
[units: mmol/l]
Mean (Standard Deviation)
  9.0  (2.7)     9.3  (1.8)     9.1  (2.2)  
Glucose 90' [7]
[units: mmol/l]
Mean (Standard Deviation)
  8.3  (2.3)     8.0  (1.8)     8.2  (2.0)  
Glucose 120' [7]
[units: mmol/l]
Mean (Standard Deviation)
  6.5  (1.7)     6.9  (2.2)     6.7  (1.9)  
Cholesterol [8]
[units: mg/dL]
Mean (Standard Deviation)
  206.0  (32.0)     195.4  (34.8)     200.7  (33.1)  
Triglycerides [8]
[units: mg/dL]
Mean (Standard Deviation)
  254.3  (55.6)     233.8  (77.7)     244.0  (66.9)  
HDL-c [8]
[units: mg/dL]
Mean (Standard Deviation)
  37.3  (3.7)     37.9  (7.7)     37.6  (5.9)  
LDL-c [8]
[units: mg/dL]
Mean (Standard Deviation)
  120.7  (32.0)     119.8  (46.5)     120.2  (39.0)  
AUC glucose [9]
[units: mmol*h/L]
Mean (Standard Deviation)
  935.8  (188.6)     950.8  (167.6)     943.3  (174.6)  
AUC insuline [9]
[units: pmol*h/L]
Mean (Standard Deviation)
  48418.5  (22707.4)     62955.8  (37620.0)     55687.1  (31282.6)  
Total insulin secretion [10]
[units: unitless]
Mean (Standard Deviation)
  0.48  (0.22)     0.59  (0.29)     0.54  (0.26)  
First phase of insulin secretion [11]
[units: unitless]
Mean (Standard Deviation)
  1256.6  (601.5)     1440.0  (619.8)     1348.3  (604.6)  
Insulin sensitivity [12]
[units: unitless]
Mean (Standard Deviation)
  3.5  (1.5)     3.3  (1.5)     3.4  (1.4)  
[1] Body weight was evaluated through a bioimpedance digital scale and results are reported in kg with a decimal.
[2] Height was measured with subjects standing and the measurements were round to the nearest centimeter.
[3] Fat mass was evaluated through a bioimpedance digital scale and results are reported in kg with a decimal
[4] Waist circumference was measured with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.
[5] 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
[6] 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.
[7] 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.
[8] 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.
[9] Area under the curve (AUC) of glucose and insulin was calculated with the polygonal formula.
[10] Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose).
[11] 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’)
[12] 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
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1.  Primary:   Triglycerides Levels at Week 12   [ Time Frame: Week 12 ]

2.  Primary:   High Density Lipoprotein (c-HDL) Levels at Week 12.   [ Time Frame: Week 12 ]

3.  Primary:   Fasting Glucose Levels at Week 12.   [ Time Frame: Week 12 ]

4.  Primary:   Systolic Blood Pressure at Week 12.   [ Time Frame: Week 12 ]

5.  Primary:   First Phase of Insulin Secretion at Week 12.   [ Time Frame: Week 12 ]

6.  Primary:   Total Insulin Secretion at Week 12.   [ Time Frame: Week 12 ]

7.  Primary:   Total Insulin Sensitivity at Week 12.   [ Time Frame: Week 12 ]

8.  Primary:   Waist Circumference at Week 12   [ Time Frame: Week 12 ]

9.  Primary:   Diastolic Blood Pressure at Week 12   [ Time Frame: Week 12 ]

10.  Secondary:   Weight at Week 12.   [ Time Frame: Week 12 ]

11.  Secondary:   Body Mass Index at Week 12   [ Time Frame: Week 12 ]

12.  Secondary:   Total Cholesterol at Week 12   [ Time Frame: Week 12 ]

13.  Secondary:   Low Density Lipoproteins (c-LDL) at Week 12   [ Time Frame: Week 12 ]

14.  Secondary:   Creatinine at Week 12.   [ Time Frame: Baseline. Week 12. ]

15.  Secondary:   Uric Acid at Week 12.   [ Time Frame: Week 12. ]


  Serious Adverse Events
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Time Frame Adverse events were collected throughout the study
Additional Description No text entered.

Reporting Groups
  Description
Resveratrol

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.

Placebo

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


Serious Adverse Events
    Resveratrol     Placebo  
Total, serious adverse events      
# participants affected / at risk     0/12 (0.00%)     0/12 (0.00%)  




  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information