Study of the Mechanisms of Metabolic Adaptations to Overfeeding
Polynut
Study of the Determinants and Mechanisms of Adaptation of Metabolic Responses to Controlled Overfeeding in Female and Male Healthy Volunteers
2 other identifiers
interventional
52
1 country
1
Brief Summary
Obesity results from complex interactions between genetic and environmental factors, and are strongly associated with metabolic complications such as type 2 diabetes mellitus. Obesity is defined as an excessive fat accumulation that presents a risk to health, a risk that is highly dependent upon the type of adipose tissue accumulation, whether visceral or sub-cutaneous, but also upon the characteristics of the fat tissue, especially inflammatory cells accumulation. Because of the well known sexual difference in fat accretion, this obesity-associated risk may also be very different for men and for women. In addition, recent data indicate that various factors such as the intestinal microbiota, but also the dietary intake of protective nutrients might be important determinants of the metabolic complications of obesity. Here we propose to: 1) study the metabolic adaptations and the mechanisms of adipose tissue accumulation during a period of controlled caloric over-nutrition, both in men and in women; 2) evaluate the potential protective effects of a supplementation with polyphenols on insulin resistance and other metabolic adaptations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Dec 2013
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 21, 2014
CompletedFirst Posted
Study publicly available on registry
August 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedMarch 8, 2016
March 1, 2016
2.4 years
July 21, 2014
March 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in insulin sensitivity
Whole body insulin sensitivity will be measured during hyperinsulinemic, euglycemic clamps.
baseline, day 31 of overfeeding
Secondary Outcomes (1)
Change from baseline in muscle and adipose tissue gene expression
Baseline, day 28 of overfeeding
Study Arms (2)
Hypercaloric diet and polyphenols
EXPERIMENTALpolyphenols will consist in the administration of 1 gram (5x200 mg) of the compound bid during the entire overfeeding period. Hypercaloric diet will consist in a hypercaloric diet providing an excess of 50% KCal over daily requirements, and will last 30 days.
Hypercaloric diet and placebo
ACTIVE COMPARATORPlacebo will consist in the administration of a number of placebo pills matching that of polyphenols, in a similar way (bid) for the duration of the overfeeding experiment. Overfeeding will consist in a hypercaloric diet providing an excess of 50% KCal over daily requirements, and will last 30 days.
Interventions
Hypercaloric diet will be designed to provide 50% excess in calories compared to daily requirements. It will consist in a "snack" type, high fat and high carbohydrates diet.
Administration of polyphenols will consist in the administration of 1 gram (5x200 mg) of the compound bid during the entire overfeeding period.
Placebo will consist in the administration of a number of placebo pills matching that of polyphenols, in a similar way (bid) for the duration of the overfeeding experiment.
Eligibility Criteria
You may qualify if:
- normal healthy male and female volunteer
You may not qualify if:
- Diabetes mellitus
- High blood pressure
- Liver disease
- Kidney disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Universitaire Vaudoislead
- University of Lyoncollaborator
Study Sites (1)
CHUVaudois
Lausanne, Canton of Vaud, 1011, Switzerland
Related Publications (2)
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.
PMID: 36386937DERIVEDSegrestin 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.
PMID: 35614978DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francois P Pralong, MD
Centre Hospitalier Universitaire Vaudois
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor and Head, Cervice of Endocrinology, Diabetology and Metabolism
Study Record Dates
First Submitted
July 21, 2014
First Posted
August 26, 2014
Study Start
December 1, 2013
Primary Completion
May 1, 2016
Study Completion
January 1, 2017
Last Updated
March 8, 2016
Record last verified: 2016-03