- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02225457
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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
To achieve these goals, healthy male and female volunteers will be enrolled into a one month longitudinal, prospective study on the influence of hypercaloric overfeeding (+50% of daily caloric needs) on different tissues (adipose tissue, muscle and blood).
They will be separated into two different groups: hypercaloric nutrition and placebo, and hypercaloric nutrition and polyphenols (2g/day), where polyphenols administration will be randomized and administered in a double blind fashion. Whole body and hepatic insulin sensitivity, total energy expenditure, glucose hepatic production, protein and gene expression in muscle, adipose tissue and blood as well as intestinal microbiota will be assessed at base line, and after one month of overfeeding.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: François P Pralong, MD
- Phone Number: +41 21 314 0596
- Email: Francois.Pralong@chuv.ch
Study Locations
-
-
Vaud
-
Lausanne, Vaud, Switzerland, 1011
- Recruiting
- CHUVaudois
-
Contact:
- Weilin Kong, MD
-
Principal Investigator:
- Francois P Pralong, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- normal healthy male and female volunteer
Exclusion Criteria:
- Diabetes mellitus
- High blood pressure
- Liver disease
- Kidney disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hypercaloric diet and polyphenols
polyphenols 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 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.
Other Names:
Administration of polyphenols will consist in the administration of 1 gram (5x200 mg) of the compound bid during the entire overfeeding period.
|
Active Comparator: Hypercaloric diet and placebo
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. Overfeeding will consist in a hypercaloric diet providing an excess of 50% KCal over daily requirements, and will last 30 days. |
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.
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in insulin sensitivity
Time Frame: baseline, day 31 of overfeeding
|
Whole body insulin sensitivity will be measured during hyperinsulinemic, euglycemic clamps.
|
baseline, day 31 of overfeeding
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in muscle and adipose tissue gene expression
Time Frame: Baseline, day 28 of overfeeding
|
Transcriptomic experiments will be performed on muscle and adipose tissue samples
|
Baseline, day 28 of overfeeding
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Francois P Pralong, MD, Centre Hospitalier Universitaire Vaudois
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 391/13
- SNF 320030_141065 (Other Grant/Funding Number: Swiss National Science Foundation)
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