Obesity, Insulin Sensitivity, Type 2 Diabetes MellitusNCT01302639
Dietary Polyphenols and Lipid Oxidation
A study testing Comparison of different combinations of polyphenols with respect to effects on fat oxidation in people with Obesity, Insulin Sensitivity, Type 2 Diabetes Mellitus, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
There are strong indications that (combinations of) polyphenols may be attractive candidates in the prevention of the metabolic syndrome and diabetes through modulation of pathways of fatty acid metabolism and mitochondrial function. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Sensitivity, Type 2 Diabetes Mellitus
- What is being tested?
- Comparison of different combinations of polyphenols with respect to effects on fat oxidation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2011to Nov 2013
- Phase
- Interventional
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- overweight men and women (BMI≥25kg/m2- 29.9 kg/m2), aged 30-70 years, Caucasian, normal fasting glucose (< 6.1 mmol/L) and blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg), weight stable in last 3 months (± 2kg). Exclusion criteria:
Who cannot join
- women lactating, pregnant or (post)menopausal, regular smokers, people with intensive fitness training, eg. athletes (≥ 3 per week ≥ 1 hour training), habitual consumption of green tea (more than 1 cup per day) or products containing green tea extract, total caffeine consumption > 300 mg/day, alcohol intake >20 g/day, any dietary vitamins or dietary supplements, diabetes mellitus (defined as FPG ≥ 7.0 mmol/l and/or 2hPG ≥ 11.1 mmol/l); serious pulmonary, cardiovascular, hepatic or renal disease : history of cardiovascular disease, all other relevant medical disorders that potentially interfere with this trial, current use of medication interfering with study intervention or interfering with study endpoints/hypotheses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Polyphenols as Modulators of Lipid Oxidation and Mitochondrial Function in Overweight Volunteers
There are strong indications that (combinations of) polyphenols may be attractive candidates in the prevention of the metabolic syndrome and diabetes through modulation of pathways of fatty acid metabolism and mitochondrial function. We hypothesize that the combination of specific polyphenols, with partly distinct mechanisms of action, may have physiologically significant effects on fat oxidation through additive or synergistic effects, thereby improving body composition, insulin sensitivity and preventing type 2 diabetes. The following objective will be addressed in the current study:
(1) to test short term (3 day) effects of combinations of polyphenols (supplements of EGCG either in combination with resveratrol or with resveratrol and genistein) to affect systemic lipolysis and fat oxidation during overnight fasted conditions and after ingestion of a high fat meal in overweight subjects
- Being tested
- Comparison of different combinations of polyphenols with respect to effects on fat oxidation
- Medical subject headings
- Obesity, Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of different combinations of polyphenols with respect to effects on fat oxidationDietary supplement
EGCG, resveratol and genistein
| Study group | Role | What they receive |
|---|---|---|
| EGCG and resveratrol | Experimental | Not described Receives: Dietary Supplement: Comparison of different combinations of polyphenols with respect to effects on fat oxidation |
| EGCG, resveratrol and genistein | Experimental | Not described Receives: Dietary Supplement: Comparison of different combinations of polyphenols with respect to effects on fat oxidation |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: Comparison of different combinations of polyphenols with respect to effects on fat oxidation |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial fat oxidation
3 day supplementation of different combinations of polyphenols in a randomised crossover design in healthy overweight volunteers.
At the end of each supplementation period, postprandial fat oxidation is measured
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, Insulin Sensitivity, Type 2 Diabetes MellitusStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Alpro Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302639
- Sponsor's protocol ID
- MEC 10-03-032.7
- Status last verified
- Sep 2014
- First submitted
- 22 Feb 2011
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Most J, Goossens GH, Jocken JW, Blaak EE. Short-term supplementation with a specific combination of dietary polyphenols increases energy expenditure and alters substrate metabolism in overweight subjects. Int J Obes (Lond). 2014 May;38(5):698-706. doi: 10.1038/ijo.2013.231. Epub 2013 Dec 9.
PubMed 24317366
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Polyphenols as Modulators of Lipid Oxidation and Mitochondrial Function in Overweight Volunteers
- ClinicalTrials.gov ID
- NCT01302639
- Acronym / sponsor ID
- MEC 10-03-032.7
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Alpro Foundation
- Study start
- Feb 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Feb 2011 (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.
There are strong indications that (combinations of) polyphenols may be attractive candidates in the prevention of the metabolic syndrome and diabetes through modulation of pathways of fatty acid metabolism and mitochondrial function. We hypothesize that the combination of specific polyphenols, with partly distinct mechanisms of action, may have physiologically significant effects on fat oxidation through additive or synergistic effects, thereby improving body composition, insulin sensitivity and preventing type 2 diabetes. The following objective will be addressed in the current study:
(1) to test short term (3 day) effects of combinations of polyphenols (supplements of EGCG either in combination with resveratrol or with resveratrol and genistein) to affect systemic lipolysis and fat oxidation during overnight fasted conditions and after ingestion of a high fat meal in overweight subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EGCG and resveratrol | Experimental | Dietary Supplement: Comparison of different combinations of polyphenols with respect to effects on fat oxidation |
| EGCG, resveratrol and genistein | Experimental | Dietary Supplement: Comparison of different combinations of polyphenols with respect to effects on fat oxidation |
| placebo | Placebo comparator | Dietary Supplement: Comparison of different combinations of polyphenols with respect to effects on fat oxidation |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- overweight men and women (BMI≥25kg/m2- 29.9 kg/m2), aged 30-70 years, Caucasian, normal fasting glucose (< 6.1 mmol/L) and blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg), weight stable in last 3 months (± 2kg). Exclusion criteria:
Key exclusion criteria (1 listed)
- women lactating, pregnant or (post)menopausal, regular smokers, people with intensive fitness training, eg. athletes (≥ 3 per week ≥ 1 hour training), habitual consumption of green tea (more than 1 cup per day) or products containing green tea extract, total caffeine consumption > 300 mg/day, alcohol intake >20 g/day, any dietary vitamins or dietary supplements, diabetes mellitus (defined as FPG ≥ 7.0 mmol/l and/or 2hPG ≥ 11.1 mmol/l); serious pulmonary, cardiovascular, hepatic or renal disease : history of cardiovascular disease, all other relevant medical disorders that potentially interfere with this trial, current use of medication interfering with study intervention or interfering with study endpoints/hypotheses.
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 |
|---|---|---|
| Comparison of different combinations of polyphenols with respect to effects on fat oxidationEGCG, resveratol and genistein | Dietary supplement | EGCG and resveratrol, EGCG, resveratrol and genistein, placebo |
Primary outcome
postprandial fat oxidation
Time frame: 3 days
3 day supplementation of different combinations of polyphenols in a randomised crossover design in healthy overweight volunteers. At the end of each supplementation period, postprandial fat oxidation is measured
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 9 Sep 2014.
- Derived from this study: PubMed 24317366Most J, Goossens GH, Jocken JW, Blaak EE. Short-term supplementation with a specific combination of dietary polyphenols increases energy expenditure and alters substrate metabolism in overweight subjects. Int J Obes (Lond). 2014 May;38(5):698-706. doi: 10.1038/ijo.2013.231. Epub 2013 Dec 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of different combinations of polyphenols with respect to effects on fat oxidation in people with Obesity, Insulin Sensitivity, Type 2 Diabetes Mellitus, run by Maastricht University Medical Center at 1 site in Netherlands.
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 1 inclusion and 1 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 9 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 Netherlands. 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.
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?
postprandial fat oxidation (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01302639, which also lists 1 linked publication.
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 9 Sep 2014; AzTrials last refreshed its copy on 31 Oct 2026.