HealthyNCT02381145
Dietary Polyphenols and Insulin Sensitivity in Overweight and Obese Humans
A study testing EGCG+RSV-supplementation in people with Healthy, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In this double-blind, randomized, placebo-controlled study, we aim to investigate the effects of a long-term supplementation on insulin sensitivity, mitochondrial function and substrate metabolism in healthy overweight men and women. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- EGCG+RSV-supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2012to Sep 2014
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight men and women (BMI≥25kg/m2-39.9kg/m2),
- Aged 20-35 and 35-50 years
- Caucasian
- Normal fasting glucose (< 6.1 mmol/L) and normal postprandial glucose (2h-glucose <7.8 mm)
- Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg)
- Weight stable in last 3 months (± 2kg)
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 (1 can of cola or 2 cups of regular coffee or 2 cups of black tea or 1 cup of coffee and 1 cup of black tea or other combinations)
- Alcohol intake >20 g/day (2 glasses of beer or wine)
Show all 21Show fewer
- 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 (e.g. history of gastro-intestinal, liver or thyroid disorders)
- Current use of medication interfering with study intervention or interfering with study endpoints/hypotheses (e.g. medication containing caffeine like analgesics, anorectics and analeptics)
- Not to be able to understand the study information
- Subjects on a special diet or vegetarian
- Blood donation 2 months prior to the study and during the study
- Participation in other studies
- Drug use
- Coagulation disorders (i.e. hemophilia (type A, B and C), von Willebrand disease, vitamin K deficiency, afibrinogenemia, disseminated intravascular coagulation and thrombosis)
- Use of anti-coagulant medication
- Acute or history of gastrointestinal diseases (Morbus Crohn, Colitis Ulcerosa)
- Intake of Antibiotics for the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Supplementation of Dietary Polyphenols as Modulators of Lipid Oxidation and Mitochondrial Function in Overweight Volunteers
In this double-blind, randomized, placebo-controlled study, we aim to investigate the effects of a long-term supplementation on insulin sensitivity, mitochondrial function and substrate metabolism in healthy overweight men and women.
In each group, 21 subjects consume 100mg Resveratrol (RSV) and 150mg Epigallocatechin-gallate (EGCG), respectively Placebo capsules, twice daily over a period of 12 weeks. The subjects receive the capsules after the last pre-measurement and continue to take them throughout the post-measurements.
Read more
Before and after the supplementation period, we perform a hyperinsulinemic-euglycemic clamp with a glucose-tracer infusion to assess hepatic and systemic insulin sensitivity. Simultaneously, substrate oxidation is measured throughout the clamp by indirect calorimetry. Furthermore, we perform a high-fat mixed meal test, in which we collect blood and measure substrate oxidation during fasted and postprandial conditions. During the meal tests, extra plasma is collected at the start (t=-30) and the end (t=240), of which the supernatant is stored in light-protected tubes (EGCG is mixed 1:1 with an EGCG buffer) for analyzing polyphenol concentrations in the blood.
In the male subgroup (21 men), we additionally place each 2 microdialysis probes in the subcutaneous adipose tissue and the gastrocnemius in order to assess local lipolysis and blood flow by means of ethanol infusion.
Furthermore, a dexa-scan is performed to assess body composition and biopsies are taken under fasted conditions from the subcutaneous adipose tissue and the quadriceps femoralis muscle. These samples are stored at -80C. Part of the adipose tissue samples is collected to measure adipocyte size. Of the skeletal muscle biopsy, one part is directly buffered and used for the oxygraph to measure mitochondrial function.
At last, feces samples are collected before and after the intervention in order to assess energy content, microbial composition and short-chain fatty acid content.
Based on previous human studies in our and other departments, we hypothesize that after 12 weeks of the combined polyphenol supplementation, insulin sensitivity and mitochondrial function improve. Furthermore, based on results of a short-term study performed by our group, that demonstrated an increase in energy expenditure, a positive effect on the regulation of body composition might be expected.
- Conditions
- Healthy
- Being tested
- EGCG+RSV-supplementation, Placebo
- Keywords
- Polyphenols, Resveratrol, Epigallocatechin-gallate, Insulin sensitivity, mitochondrial function, lipid oxidation, tissue lipolysis
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGCG+RSV-supplementationDietary supplement
Also called Teavigo, Pure Encapsulations Inc. (Massachusetts, USA), Resveratrol, Pure Encapsulations Inc. (Massachusetts, USA)
Teavigo (~300mg/d) Resveratrol (~80mg/d)
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | micro-cellulose-filled Placebo Receives: Dietary Supplement: Placebo |
| EGCG+RSV-supplementation | Active comparator | EGCG+RSV: 300mg/d + 80mg/d Receives: Dietary Supplement: EGCG+RSV-supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic insulin sensitivity
hyperinsulinemic euglycemic clamp with glucose-tracer
Measured: change from week 0 to week 12 after supplementation
Secondary outcomes (1)
skeletal muscle mitochondrial function
ex vivo skeletal muscle respiratory capacity
Measured: change from week 0 to week 12 after supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startAug 2012
- Primary completionMay 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen E Blaak, Prof., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381145
- Sponsor's protocol ID
- NL31421.068.10
- Status last verified
- Sep 2018
- First submitted
- 20 Aug 2013
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Jardon KM, Goossens GH, Most J, Galazzo G, Venema K, Penders J, Blaak EE. Examination of sex-specific interactions between gut microbiota and host metabolism after 12-week combined polyphenol supplementation in individuals with overweight or obesity. Gut Microbes. 2024 Jan-Dec;16(1):2392875. doi: 10.1080/19490976.2024.2392875. Epub 2024 Aug 25.
PubMed 39182247Fazelzadeh P, Hoefsloot HCJ, Hankemeier T, Most J, Kersten S, Blaak EE, Boekschoten M, van Duynhoven J. Global testing of shifts in metabolic phenotype. Metabolomics. 2018 Oct 4;14(10):139. doi: 10.1007/s11306-018-1435-8.
PubMed 30830386Most J, Goossens GH, Reijnders D, Canfora EE, Penders J, Blaak EE. Gut microbiota composition strongly correlates to peripheral insulin sensitivity in obese men but not in women. Benef Microbes. 2017 Aug 24;8(4):557-562. doi: 10.3920/BM2016.0189. Epub 2017 Jun 16.
PubMed 28618864Most J, Timmers S, Warnke I, Jocken JW, van Boekschoten M, de Groot P, Bendik I, Schrauwen P, Goossens GH, Blaak EE. Combined epigallocatechin-3-gallate and resveratrol supplementation for 12 wk increases mitochondrial capacity and fat oxidation, but not insulin sensitivity, in obese humans: a randomized controlled trial. Am J Clin Nutr. 2016 Jul;104(1):215-27. doi: 10.3945/ajcn.115.122937. Epub 2016 May 18.
PubMed 27194304
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Supplementation of Dietary Polyphenols as Modulators of Lipid Oxidation and Mitochondrial Function in Overweight Volunteers
- ClinicalTrials.gov ID
- NCT02381145
- Acronym / sponsor ID
- NL31421.068.10
- Conditions
- Healthy
- Keywords
- Polyphenols, Resveratrol, Epigallocatechin-gallate, Insulin sensitivity, mitochondrial function, lipid oxidation, tissue lipolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Mar 2015 (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.
In this double-blind, randomized, placebo-controlled study, we aim to investigate the effects of a long-term supplementation on insulin sensitivity, mitochondrial function and substrate metabolism in healthy overweight men and women.
In each group, 21 subjects consume 100mg Resveratrol (RSV) and 150mg Epigallocatechin-gallate (EGCG), respectively Placebo capsules, twice daily over a period of 12 weeks. The subjects receive the capsules after the last pre-measurement and continue to take them throughout the post-measurements.
Before and after the supplementation period, we perform a hyperinsulinemic-euglycemic clamp with a glucose-tracer infusion to assess hepatic and systemic insulin sensitivity. Simultaneously, substrate oxidation is measured throughout the clamp by indirect calorimetry. Furthermore, we perform a high-fat mixed meal test, in which we collect blood and measure substrate oxidation during fasted and postprandial conditions. During the meal tests, extra plasma is collected at the start (t=-30) and the end (t=240), of which the supernatant is stored in light-protected tubes (EGCG is mixed 1:1 with an EGCG buffer) for analyzing polyphenol concentrations in the blood.
In the male subgroup (21 men), we additionally place each 2 microdialysis probes in the subcutaneous adipose tissue and the gastrocnemius in order to assess local lipolysis and blood flow by means of ethanol infusion.
Furthermore, a dexa-scan is performed to assess body composition and biopsies are taken under fasted conditions from the subcutaneous adipose tissue and the quadriceps femoralis muscle. These samples are stored at -80C. Part of the adipose tissue samples is collected to measure adipocyte size. Of the skeletal muscle biopsy, one part is directly buffered and used for the oxygraph to measure mitochondrial function.
At last, feces samples are collected before and after the intervention in order to assess energy content, microbial composition and short-chain fatty acid content.
Based on previous human studies in our and other departments, we hypothesize that after 12 weeks of the combined polyphenol supplementation, insulin sensitivity and mitochondrial function improve. Furthermore, based on results of a short-term study performed by our group, that demonstrated an increase in energy expenditure, a positive effect on the regulation of body composition might be expected.
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 | Dietary Supplement: Placebomicro-cellulose-filled Placebo |
| EGCG+RSV-supplementation | Active comparator | Dietary Supplement: EGCG+RSV-supplementationEGCG+RSV: 300mg/d + 80mg/d |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Overweight men and women (BMI≥25kg/m2-39.9kg/m2),
- Aged 20-35 and 35-50 years
- Caucasian
- Normal fasting glucose (< 6.1 mmol/L) and normal postprandial glucose (2h-glucose <7.8 mm)
- Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg)
Key exclusion criteria (21 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 (1 can of cola or 2 cups of regular coffee or 2 cups of black tea or 1 cup of coffee and 1 cup of black tea or other combinations)
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 |
|---|---|---|
| EGCG+RSV-supplementationAlso: Teavigo, Pure Encapsulations Inc. (Massachusetts, USA), Resveratrol, Pure Encapsulations Inc. (Massachusetts, USA)Teavigo (~300mg/d) Resveratrol (~80mg/d) | Dietary supplement | EGCG+RSV-supplementation |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Systemic insulin sensitivity
Time frame: change from week 0 to week 12 after supplementation
hyperinsulinemic euglycemic clamp with glucose-tracer
1 secondary outcome
skeletal muscle mitochondrial function
Time frame: change from week 0 to week 12 after supplementation
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 5 Sep 2018.
- Derived from this study: PubMed 39182247Jardon KM, Goossens GH, Most J, Galazzo G, Venema K, Penders J, Blaak EE. Examination of sex-specific interactions between gut microbiota and host metabolism after 12-week combined polyphenol supplementation in individuals with overweight or obesity. Gut Microbes. 2024 Jan-Dec;16(1):2392875. doi: 10.1080/19490976.2024.2392875. Epub 2024 Aug 25.
- Derived from this study: PubMed 30830386Fazelzadeh P, Hoefsloot HCJ, Hankemeier T, Most J, Kersten S, Blaak EE, Boekschoten M, van Duynhoven J. Global testing of shifts in metabolic phenotype. Metabolomics. 2018 Oct 4;14(10):139. doi: 10.1007/s11306-018-1435-8.
- Derived from this study: PubMed 28618864Most J, Goossens GH, Reijnders D, Canfora EE, Penders J, Blaak EE. Gut microbiota composition strongly correlates to peripheral insulin sensitivity in obese men but not in women. Benef Microbes. 2017 Aug 24;8(4):557-562. doi: 10.3920/BM2016.0189. Epub 2017 Jun 16.
- Derived from this study: PubMed 27194304Most J, Timmers S, Warnke I, Jocken JW, van Boekschoten M, de Groot P, Bendik I, Schrauwen P, Goossens GH, Blaak EE. Combined epigallocatechin-3-gallate and resveratrol supplementation for 12 wk increases mitochondrial capacity and fat oxidation, but not insulin sensitivity, in obese humans: a randomized controlled trial. Am J Clin Nutr. 2016 Jul;104(1):215-27. doi: 10.3945/ajcn.115.122937. Epub 2016 May 18.
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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.
Ellen E Blaak, Prof. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EGCG+RSV-supplementation in people with Healthy, 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 6 inclusion and 21 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 5 Sep 2018. 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?
Systemic insulin sensitivity (time frame: change from week 0 to week 12 after supplementation). 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 NCT02381145, which also lists 4 linked publications.
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 5 Sep 2018.