OverfeedingPoly-NutNCT02145780
Polyphenols and Overfeeding
A study testing 2g of grape polyphenol extract in people with Overfeeding, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Obesity is a complex and multifactorial disease representing a major public health challenge. Indeed, overweight and obese people carry a major risk of developing insulin resistance and type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overfeeding
- What is being tested?
- 2g of grape polyphenol extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to May 2017
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Aged from 18 to 55 years
- Body Mass Index of 23 to 27 kg/m²
- Normal blood pressure
- Fasting glycemia < 7 mmol/L
- CRPus < 10mg/L
- Triglycerides ≤ 3mmol/L
Who cannot join
- Medical or surgical history which may affect the results (renal -cardiovascular - hepatic- endocrine-inflammatory diseases)
- Subjects under treatment which may interfere with the measured parameters
- Eating disorder
- Intensive sportive activity
- Dairy products allergy or intolerance
Trial locations and contacts
1 site in 1 country.
France1 site
Rhône Alpes Human Nutrition Center (CRNH Rhône-Alpes)
Pierre-Bénite, 69495
About this study
Official title: Polyphenols: Protection From Overfeeding-induced Insulin Resistance?
Obesity is a complex and multifactorial disease representing a major public health challenge. Indeed, overweight and obese people carry a major risk of developing insulin resistance and type 2 diabetes mellitus. It has been demonstrated that polyphenols could be used to counteract some of the mechanisms involved in the generation of insulin resistance. The model of overfeeding represents a very good study model of the metabolic complications of obesity, since it has been shown to induce a transient state of insulin resistance in the human.
The purpose of this research is to study the effects of a overfeeding (+50% of daily caloric needs over 31 days) with or without polyphenols supplementation (2g/days over 31 days) on insulin sensitivity measured in the setting of a hyperinsulinemic euglycemic clamp and on post prandial partitioning of exogenous lipids after a test meal.
During 31 days, the volunteers will consume chocolate bars, chips, chocolate breads and cola in addition to their usual diet and will be supplemented with 2g of grape polyphenols extract or with placebo.
- Conditions
- Overfeeding
- Being tested
- 2g of grape polyphenol extract, Dietary Supplement: 2g of placebo (lactose)
- Keywords
- Overfeeding, Fat distribution, Subcutaneous and visceral adipose tissue, Insulin sensitivity, Insulin resistance, Peripheral and hepatic insulin sensitivity, Stable isotopes, Lipid oxidation, Energy expenditure, Muscle and subcutaneous adipose tissue gene expression
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2g of grape polyphenol extractDietary supplement
Men will have to consume daily 2g of grape polyphenol extract during the 31 days of overfeeding.
Dietary Supplement: 2g of placebo (lactose)Dietary supplement
Men will have to consume daily 2g of placebo during the 31 days of overfeeding.
| Study group | Role | What they receive |
|---|---|---|
| 2g of grape polyphenol extract supplement | Experimental | Men will have to consume daily 2g of grape polyphenol extract during the 31 days of overfeeding. Receives: Dietary Supplement: 2g of grape polyphenol extract |
| 2g of placebo (lactose) | Placebo comparator | Men will have to consume daily 2g of placebo during the 31 days of overfeeding. Receives: Dietary Supplement: Dietary Supplement: 2g of placebo (lactose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral insulin sensitivity
Volunteers will have peripheral and hepatic insulin sensitivity determined by using a two-stage hyperinsulinemic euglycemic clamp with stable isotopically labeled tracer infusion.
Measured: During 31 days
Secondary outcomes (6)
Hepatic insulin sensitivity
Endogenous glucose production (EGP) will be determined during the last 30 minutes of the low-dose insulin infusion.
Measured: before and after the 31 days of overfeeding
Change in genes expression in adipose and muscle tissues
RT-PCR
Measured: Before and after the 31 days of overfeeding
Anthropometry, Fat quantification and Abdominal fat distribution
Weight, height, waist and hip circumferences, fat mass using dual x-ray absorptiometry (DEXA) and abdominal fat distribution using resonance magnetic imaging (RMI).
Measured: During 31 days
Fasting and Postprandial partitioning of exogenous lipid
13C enrichment will be measured in blood samples and breath test during a test meal performed before and after the 31 days of overfeeding.
Measured: Fasting and during all the postprandial period (0-300 minutes)
Modification in intestinal microbiota
Feces analyses
Measured: Before and after the 31 days of overfeeding
Energy expenditure and substrate oxidation with indirect calorimetry
Energy metabolism will be measured before and after the 31 days of overfeeding.
Measured: Fasting and during all the postprandial period (0-300 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverfeedingStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine LAVILLE, MD, PhD, Principal investigator, Rhône Alpes Human Nutrition Center (CRNH Rhône-Alpes)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145780
- Sponsor's protocol ID
- 2013-807
- Acronym
- Poly-Nut
- Status last verified
- Aug 2017
- First submitted
- 13 May 2014
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bartova S, Madrid-Gambin F, Fernandez L, Carayol J, Meugnier E, Segrestin B, Delage P, Vionnet N, Boizot A, Laville M, Vidal H, Marco S, Hager J, Moco S. Grape polyphenols decrease circulating branched chain amino acids in overfed adults. Front Nutr. 2022 Oct 26;9:998044. doi: 10.3389/fnut.2022.998044. eCollection 2022.
PubMed 36386937Segrestin B, Delage P, Nemeth A, Seyssel K, Disse E, Nazare JA, Lambert-Porcheron S, Meiller L, Sauvinet V, Chanon S, Simon C, Ratiney H, Beuf O, Pralong F, Yassin NA, Boizot A, Gachet M, Burton-Pimentel KJ, Vidal H, Meugnier E, Vionnet N, Laville M. Polyphenol Supplementation Did Not Affect Insulin Sensitivity and Fat Deposition During One-Month Overfeeding in Randomized Placebo-Controlled Trials in Men and in Women. Front Nutr. 2022 May 9;9:854255. doi: 10.3389/fnut.2022.854255. eCollection 2022.
PubMed 35614978
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyphenols: Protection From Overfeeding-induced Insulin Resistance?
- ClinicalTrials.gov ID
- NCT02145780
- Acronym / sponsor ID
- Poly-Nut / 2013-807
- Conditions
- Overfeeding
- Keywords
- Overfeeding, Fat distribution, Subcutaneous and visceral adipose tissue, Insulin sensitivity, Insulin resistance, Peripheral and hepatic insulin sensitivity, Stable isotopes, Lipid oxidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 23 May 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.
Obesity is a complex and multifactorial disease representing a major public health challenge. Indeed, overweight and obese people carry a major risk of developing insulin resistance and type 2 diabetes mellitus. It has been demonstrated that polyphenols could be used to counteract some of the mechanisms involved in the generation of insulin resistance. The model of overfeeding represents a very good study model of the metabolic complications of obesity, since it has been shown to induce a transient state of insulin resistance in the human.
The purpose of this research is to study the effects of a overfeeding (+50% of daily caloric needs over 31 days) with or without polyphenols supplementation (2g/days over 31 days) on insulin sensitivity measured in the setting of a hyperinsulinemic euglycemic clamp and on post prandial partitioning of exogenous lipids after a test meal.
During 31 days, the volunteers will consume chocolate bars, chips, chocolate breads and cola in addition to their usual diet and will be supplemented with 2g of grape polyphenols extract or with placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2g of grape polyphenol extract supplement | Experimental | Dietary Supplement: 2g of grape polyphenol extractMen will have to consume daily 2g of grape polyphenol extract during the 31 days of overfeeding. |
| 2g of placebo (lactose) | Placebo comparator | Dietary Supplement: Dietary Supplement: 2g of placebo (lactose)Men will have to consume daily 2g of placebo during the 31 days of overfeeding. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male
- Aged from 18 to 55 years
- Body Mass Index of 23 to 27 kg/m²
- Normal blood pressure
- Fasting glycemia < 7 mmol/L
Key exclusion criteria (5 listed)
- Medical or surgical history which may affect the results (renal -cardiovascular - hepatic- endocrine-inflammatory diseases)
- Subjects under treatment which may interfere with the measured parameters
- Eating disorder
- Intensive sportive activity
- Dairy products allergy or intolerance
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 |
|---|---|---|
| 2g of grape polyphenol extractMen will have to consume daily 2g of grape polyphenol extract during the 31 days of overfeeding. | Dietary supplement | 2g of grape polyphenol extract supplement |
| Dietary Supplement: 2g of placebo (lactose)Men will have to consume daily 2g of placebo during the 31 days of overfeeding. | Dietary supplement | 2g of placebo (lactose) |
Primary outcome
Peripheral insulin sensitivity
Time frame: During 31 days
Volunteers will have peripheral and hepatic insulin sensitivity determined by using a two-stage hyperinsulinemic euglycemic clamp with stable isotopically labeled tracer infusion.
6 secondary outcomes
Hepatic insulin sensitivity
Time frame: before and after the 31 days of overfeeding
Change in genes expression in adipose and muscle tissues
Time frame: Before and after the 31 days of overfeeding
Anthropometry, Fat quantification and Abdominal fat distribution
Time frame: During 31 days
Fasting and Postprandial partitioning of exogenous lipid
Time frame: Fasting and during all the postprandial period (0-300 minutes)
Modification in intestinal microbiota
Time frame: Before and after the 31 days of overfeeding
Energy expenditure and substrate oxidation with indirect calorimetry
Time frame: Fasting and during all the postprandial period (0-300 minutes)
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 23 Aug 2017.
- Derived from this study: PubMed 36386937Bartova S, Madrid-Gambin F, Fernandez L, Carayol J, Meugnier E, Segrestin B, Delage P, Vionnet N, Boizot A, Laville M, Vidal H, Marco S, Hager J, Moco S. Grape polyphenols decrease circulating branched chain amino acids in overfed adults. Front Nutr. 2022 Oct 26;9:998044. doi: 10.3389/fnut.2022.998044. eCollection 2022.
- Derived from this study: PubMed 35614978Segrestin B, Delage P, Nemeth A, Seyssel K, Disse E, Nazare JA, Lambert-Porcheron S, Meiller L, Sauvinet V, Chanon S, Simon C, Ratiney H, Beuf O, Pralong F, Yassin NA, Boizot A, Gachet M, Burton-Pimentel KJ, Vidal H, Meugnier E, Vionnet N, Laville M. Polyphenol Supplementation Did Not Affect Insulin Sensitivity and Fat Deposition During One-Month Overfeeding in Randomized Placebo-Controlled Trials in Men and in Women. Front Nutr. 2022 May 9;9:854255. doi: 10.3389/fnut.2022.854255. eCollection 2022.
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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.
Martine LAVILLE, MD, PhD principal investigator
Rhône Alpes Human Nutrition Center (CRNH Rhône-Alpes)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2g of grape polyphenol extract in people with Overfeeding, run by Hospices Civils de Lyon at 1 site in France.
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 7 inclusion and 5 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 23 Aug 2017. 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 France. 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?
Peripheral insulin sensitivity (time frame: During 31 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 NCT02145780, which also lists 2 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 23 Aug 2017.