NCT02247596

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_2 obesity

Timeline
Completed

Started Jul 2009

Typical duration for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

3.3 years

First QC Date

September 17, 2014

Last Update Submit

September 19, 2014

Conditions

ObesityDiabetes

Keywords

Resveratrolobesityinsulin resistanceenergy expenditurediabetes

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Resting Energy Expenditure via indirect calorimetry at 2 weeks

    Measured in Kcal/day using a metabolic cart

    2 weeks (pre and post intervention)

Secondary Outcomes (4)

  • Change from baseline in insulin resistance via Homeostasis Model Assessment (HOMA) 2 calculator at 2 weeks

    2 weeks (pre and post intervention)

  • Change from baseline in lipid subfractions at 2 weeks

    2 weeks (pre and post intervention)

  • Change from baseline in Blood pressure at 2 weeks

    2 weeks (pre and post intervention)

  • Change from baseline in Glycated hemoglobin at 2 weeks

    2 weeks (pre and post intervention)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Sugar pill 1g tds for 2 weeks

Drug: Placebo

Resveratrol

EXPERIMENTAL

Trans-resveratrol extract from Polygonum Cuspidatum 1g three times a day for 2 weeks

Drug: Resveratrol

Interventions

ResveratrolDRUG

1g tds 2 weeks

Also known as: Mega Resveratrol
Resveratrol
PlaceboDRUG

Sugar pill 1g tds for 2 weeks

Placebo

Eligibility Criteria

Age21 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khoo Teck Puat Hospital

Singapore, 768828, Singapore

Location

MeSH Terms

Conditions

ObesityDiabetes MellitusInsulin Resistance

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Kian Peng Goh

    Khoo Teck Puat Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 17, 2014

First Posted

September 25, 2014

Study Start

July 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

SG(1)