ObesityPhase 2NCT02247596
Effects of High-Dose Resveratrol in Non-Diabetic Obese Males
A Phase 2 study testing Resveratrol in people with Obesity and Diabetes, run by Khoo Teck Puat Hospital at 1 site in Singapore.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 55 years, men onlyHealthy volunteers can take part
- What is being tested?
- Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2009to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High-Dose Resveratrol on Resting Energy Expenditure and HOMA in Non-Diabetic Obese Males
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).
Read the 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).
- Being tested
- Resveratrol, Placebo
- Keywords
- Resveratrol, obesity, insulin resistance, energy expenditure, diabetes
- Medical subject headings
- Obesity, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDrug
Also called Mega Resveratrol
1g tds 2 weeks
PlaceboDrug
Sugar pill 1g tds for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Sugar pill 1g tds for 2 weeks Receives: Drug: Placebo |
| Resveratrol | Experimental | Trans-resveratrol extract from Polygonum Cuspidatum 1g three times a day for 2 weeks Receives: Drug: Resveratrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Resting Energy Expenditure via indirect calorimetry at 2 weeks
Measured in Kcal/day using a metabolic cart
Measured: 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
Beta cell function, B (%),Insulin sensitivity, S (%), Insulin resistance, IR
Measured: 2 weeks (pre and post intervention)
Change from baseline in lipid subfractions at 2 weeks
LDL, HDL and triglycerides in mmol/L
Measured: 2 weeks (pre and post intervention)
Change from baseline in Blood pressure at 2 weeks
Systolic and diastolic blood pressure in mmHg
Measured: 2 weeks (pre and post intervention)
Change from baseline in Glycated hemoglobin at 2 weeks
HbA1c in %
Measured: 2 weeks (pre and post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startJul 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khoo Teck Puat Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Principal investigator, Goh Kian Peng, Khoo Teck Puat Hospital
- Investigators
- Kian Peng Goh, Principal investigator, Khoo Teck Puat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247596
- Sponsor's protocol ID
- 2009/00454
- Other IDs
- 2009
- Status last verified
- Sep 2014
- First submitted
- 17 Sep 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Dose Resveratrol on Resting Energy Expenditure and HOMA in Non-Diabetic Obese Males
- ClinicalTrials.gov ID
- NCT02247596
- Acronym / sponsor ID
- 2009/00454
- Keywords
- Resveratrol, obesity, insulin resistance, energy expenditure, diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Khoo Teck Puat HospitalUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- Jul 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSugar pill 1g tds for 2 weeks |
| Resveratrol | Experimental | Drug: ResveratrolTrans-resveratrol extract from Polygonum Cuspidatum 1g three times a day for 2 weeks |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResveratrolAlso: Mega Resveratrol1g tds 2 weeks | Drug | Resveratrol |
| PlaceboSugar pill 1g tds for 2 weeks | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
Change from baseline in insulin resistance via Homeostasis Model Assessment (HOMA) 2 calculator at 2 weeks
Time frame: 2 weeks (pre and post intervention)
Change from baseline in lipid subfractions at 2 weeks
Time frame: 2 weeks (pre and post intervention)
Change from baseline in Blood pressure at 2 weeks
Time frame: 2 weeks (pre and post intervention)
Change from baseline in Glycated hemoglobin at 2 weeks
Time frame: 2 weeks (pre and post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kian Peng Goh principal investigator
Khoo Teck Puat Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resveratrol in people with Obesity and Diabetes, run by Khoo Teck Puat Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Resting Energy Expenditure via indirect calorimetry at 2 weeks (time frame: 2 weeks (pre and post intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.