ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of High-Dose Resveratrol in Non-Diabetic Obese Males

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02247596
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
Goh Kian Peng, Khoo Teck Puat Hospital

Brief Summary:
The primary aim of our study was to examine the effects of two weeks of oral resveratrol on resting energy expenditure and insulin sensitivity in non-diabetic obese male subjects. Secondary variables included plasma lipid subfraction, blood pressure and glycated hemoglobin (HbA1c).

Condition or disease Intervention/treatment Phase
Obesity Diabetes Drug: Resveratrol Drug: Placebo Phase 2

Detailed Description:

Patients were recruited between July 2009 and July 2012 from a single hospital in Singapore. Eligible patients were Chinese males, aged between 21 and 55 years old, with a body mass index (BMI) of 30 kg/m2 or more and venous glucose of <7.0 and <11.1 mmol/L at 0 and 120 minutes respectively on oral glucose tolerance testing (OGTT) following a 12-hour fast. They must be willing to abstain from embarking on an exercise regime or ingesting large quantities of resveratrol-containing foods including alcohol during the study period.

The study was a randomized, double-blind, parallel group trial consisting of a screening visit, a two-week treatment period and a post-treatment visit.

Randomization was centrally performed during treatment assignment with a 2-digit reference code placed in sealed opaque envelopes maintained by the person responsible for the preparation of the intervention drug and placebo. Trans-resveratrol extract from Polygonum Cuspidatum (Mega Resveratrol, Danbury, USA) was used in the trial. The placebo was not distinguishable by color, form, or taste from the active drug. The randomization code was unblinded only after all predefined data were recorded.

Subjects were given 1g three times a day of either resveratrol or placebo for two weeks and instructed to abstain from foods with high resveratrol content during the entire duration of the trial. Compliance was determined by pill counting at the end of the trial period. Subjects in both arms were not allowed to commence on an exercise regimen or supplements during the study period. Subjects who dropped out of the trial would not be replaced. All variables were measured at baseline and at the end of the treatment period.

RMR was measured by indirect calorimetry using a breath-by-breath metabolic gas analyser via the face-mask method.

The investigators estimated that a sample size of 18 patients per group (Total N = 36) was needed to provide 80% power and two-sided 5% to detect a difference in a Cohen's effect size of 1.0 between the two groups.

All analyses were performed using SPSS 21.0 (IBM) with statistical significance set at p < 0.05 and with the percentage change from baseline as the unit of analysis. All data were analyzed according to the intention-to-treat principle. MANOVA was performed to compare the intervention and placebo groups for the unadjusted and adjusted p-values on the study variables of interest. Normal distribution was verified with the Kolmogorov-Smirnov test and data were presented as mean ± standard deviation (SD).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of High-Dose Resveratrol on Resting Energy Expenditure and HOMA in Non-Diabetic Obese Males
Study Start Date : July 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Sugar pill 1g tds for 2 weeks
Drug: Placebo
Sugar pill 1g tds for 2 weeks
Experimental: Resveratrol
Trans-resveratrol extract from Polygonum Cuspidatum 1g three times a day for 2 weeks
Drug: Resveratrol
1g tds 2 weeks
Other Name: Mega Resveratrol



Primary Outcome Measures :
  1. Change from baseline in Resting Energy Expenditure via indirect calorimetry at 2 weeks [ Time Frame: 2 weeks (pre and post intervention) ]
    Measured in Kcal/day using a metabolic cart


Secondary Outcome Measures :
  1. Change from baseline in insulin resistance via Homeostasis Model Assessment (HOMA) 2 calculator at 2 weeks [ Time Frame: 2 weeks (pre and post intervention) ]
    Beta cell function, B (%),Insulin sensitivity, S (%), Insulin resistance, IR

  2. Change from baseline in lipid subfractions at 2 weeks [ Time Frame: 2 weeks (pre and post intervention) ]
    LDL, HDL and triglycerides in mmol/L

  3. Change from baseline in Blood pressure at 2 weeks [ Time Frame: 2 weeks (pre and post intervention) ]
    Systolic and diastolic blood pressure in mmHg

  4. Change from baseline in Glycated hemoglobin at 2 weeks [ Time Frame: 2 weeks (pre and post intervention) ]
    HbA1c in %



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ability to give informed consent
  • Obese Chinese Male
  • Age 21 to 55 yrs old
  • No diabetes mellitus
  • BMI of 30 kg/m2 or more during screening

Exclusion Criteria:

  • Unwilling to abstain from ingesting large quantities of resveratrol-containing foods (eg. red wine, nuts)
  • Cancer diagnosis that is currently under treatment, is clinically detectable, or that has been treated within the past 5 years
  • Terminal disease or on palliative care
  • Current excessive alcohol intake (>21 units per week for men; 14 units per week for women)
  • Known diabetes mellitus
  • Past history of unexplained hypoglycemia
  • Past or current history of strokes
  • History of any grape allergy
  • On alternative or traditional medications
  • Treated with another investigational drug within last 6 months
  • Poorly controlled hypertension (SBP >/= 160 or DBP >/= 100) within last one month
  • ALT and/or AST > 1.5 times above upper limit of normal within last 6 months
  • GFR < 50 ml/min/1.73m2 (MDRD equation) within last 6 months
  • Staff of Department of Medicine, Khoo Teck Puat Hospital

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247596


Locations
Singapore
Khoo Teck Puat Hospital
Singapore, Singapore, 768828
Sponsors and Collaborators
Khoo Teck Puat Hospital
National Medical Research Council (NMRC), Singapore
Investigators
Principal Investigator: Kian Peng Goh Khoo Teck Puat Hospital

Responsible Party: Goh Kian Peng, PI, Khoo Teck Puat Hospital
ClinicalTrials.gov Identifier: NCT02247596     History of Changes
Other Study ID Numbers: 2009/00454
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by Goh Kian Peng, Khoo Teck Puat Hospital:
Resveratrol
obesity
insulin resistance
energy expenditure
diabetes

Additional relevant MeSH terms:
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents