Phase 2 N=24 Randomized Double-blind Treatment

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

Metabolic Syndrome X

Bottom Line

View on ClinicalTrials.gov: NCT02114892 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: Triglycerides Levels at Week 12 — 210.6; 235.8 mg/dL — p=0.131

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Resveratrol (Drug); Placebo (Drug)
Age: Adult · 30+ yrs
Sex: All
Sponsor: University of Guadalajara
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Triglycerides Levels at Week 12	210.6; 235.8	0.131
PRIMARY High Density Lipoprotein (c-HDL) Levels at Week 12.	37.6; 41.1	0.859
PRIMARY Fasting Glucose Levels at Week 12.	4.6; 4.5	0.070
PRIMARY Systolic Blood Pressure at Week 12.	116.1; 121.7	0.338
PRIMARY First Phase of Insulin Secretion at Week 12.	1019.7; 1279.3	0.278
PRIMARY Total Insulin Secretion at Week 12.	.28; .60	<0.01 sig
PRIMARY Total Insulin Sensitivity at Week 12.	4.2; 4.7	0.083
PRIMARY Waist Circumference at Week 12	105.4; 105.8	<0.01 sig
PRIMARY Diastolic Blood Pressure at Week 12	78.1; 78.9	0.672
SECONDARY Weight at Week 12.	90.5; 93.1	<0.01 sig
SECONDARY Body Mass Index at Week 12	34.3; 34.0	<0.01 sig
SECONDARY Total Cholesterol at Week 12	203.4; 208.9	0.946
SECONDARY Low Density Lipoproteins (c-LDL) at Week 12	122.3; 126.8	0.365
SECONDARY Creatinine at Week 12.	57.94; 63.29	0.557
SECONDARY Uric Acid at Week 12.	277.93; 364.03	<0.01 sig

Summary

The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease. Resveratrol is a substance found in many plants, including grapes, nuts and wine, but it's also found in Polygonum cuspidatum. There is evidence that resveratrol consumption has beneficial effects on glucose and lipids metabolism, blood pressure and body weight. The aim of this study was to evaluate the effect of resveratrol on metabolic syndrome, insulin sensitivity and insulin secretion. The investigators hypothesis was that the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

Eligibility Criteria

Inclusion Criteria

Patients both sexes
Age between 30 and 50 years
Metabolic Syndrome according to the IDF criteria
Waist circumference
Man ≥90 cm
Woman ≥80 cm
And two of the following criteria:
High density lipoprotein
Man ≤40 mg/dL
Woman ≤50 mg/dL
Fasting glucose ≥100 mg/dL
Triglycerides ≥150 mg/dL
Blood pressure ≥130/85 mmHg
Informed consent signed

Exclusion Criteria

Women with confirmed or suspected pregnancy
Women under lactation and/or puerperium
Hypersensibility to resveratrol
Physical impossibility for taking pills
Known uncontrolled renal, hepatic, heart or thyroid diseased
Previous treatment for the metabolic syndrome components
Body Mass Index ≥39.9 kg/m2
Fasting glucose ≥126 mg/dL
Triglycerides ≥500 mg/dL
Total cholesterol ≥240 mg/dL
Low density lipoprotein (c-LDL) ≥190 mg/dL
Blood Pressure ≥140/90 mmHg

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02114892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.