Polyphenols and Overfeeding (Poly-Nut)
22. august 2017 opdateret af: Hospices Civils de Lyon
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
42
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Pierre-bénite, Frankrig, 69495
- Rhône Alpes Human Nutrition Center (CRNH Rhône-Alpes)
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 55 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 2g of grape polyphenol extract supplement
Men will have to consume daily 2g of grape polyphenol extract during the 31 days of overfeeding.
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Men will have to consume daily 2g of grape polyphenol extract during the 31 days of overfeeding.
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Placebo komparator: 2g of placebo (lactose)
Men will have to consume daily 2g of placebo during the 31 days of overfeeding.
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Men will have to consume daily 2g of placebo during the 31 days of overfeeding.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Peripheral insulin sensitivity
Tidsramme: During 31 days
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Volunteers will have peripheral and hepatic insulin sensitivity determined by using a two-stage hyperinsulinemic euglycemic clamp with stable isotopically labeled tracer infusion.
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During 31 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Hepatic insulin sensitivity
Tidsramme: before and after the 31 days of overfeeding
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Endogenous glucose production (EGP) will be determined during the last 30 minutes of the low-dose insulin infusion.
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before and after the 31 days of overfeeding
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Change in genes expression in adipose and muscle tissues
Tidsramme: Before and after the 31 days of overfeeding
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RT-PCR
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Before and after the 31 days of overfeeding
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Anthropometry, Fat quantification and Abdominal fat distribution
Tidsramme: During 31 days
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Weight, height, waist and hip circumferences, fat mass using dual x-ray absorptiometry (DEXA) and abdominal fat distribution using resonance magnetic imaging (RMI).
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During 31 days
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Fasting and Postprandial partitioning of exogenous lipid
Tidsramme: Fasting and during all the postprandial period (0-300 minutes)
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13C enrichment will be measured in blood samples and breath test during a test meal performed before and after the 31 days of overfeeding.
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Fasting and during all the postprandial period (0-300 minutes)
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Modification in intestinal microbiota
Tidsramme: Before and after the 31 days of overfeeding
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Feces analyses
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Before and after the 31 days of overfeeding
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Energy expenditure and substrate oxidation with indirect calorimetry
Tidsramme: Fasting and during all the postprandial period (0-300 minutes)
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Energy metabolism will be measured before and after the 31 days of overfeeding.
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Fasting and during all the postprandial period (0-300 minutes)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Martine LAVILLE, MD, PhD, Rhône Alpes Human Nutrition Center (CRNH Rhône-Alpes)
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- Segrestin 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. februar 2014
Primær færdiggørelse (Faktiske)
1. maj 2017
Studieafslutning (Faktiske)
1. maj 2017
Datoer for studieregistrering
Først indsendt
13. maj 2014
Først indsendt, der opfyldte QC-kriterier
20. maj 2014
Først opslået (Skøn)
23. maj 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2013-807
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .