Study of the Mechanisms of Metabolic Adaptations to Overfeeding

NCT ID: NCT02225457

Last Updated: 2016-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2017-01-31

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.

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.

Conditions

Obesity; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Hypercaloric diet

Intervention Type: OTHER

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.

polyphenols

Intervention Type: DIETARY_SUPPLEMENT

Administration of polyphenols will consist in the administration of 1 gram (5x200 mg) of the compound bid during the entire overfeeding period.

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.

Group Type: ACTIVE_COMPARATOR

Hypercaloric diet

Intervention Type: OTHER

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.

placebo (for polyphenols)

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Hypercaloric diet

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.

Intervention Type: OTHER

polyphenols

Administration of polyphenols will consist in the administration of 1 gram (5x200 mg) of the compound bid during the entire overfeeding period.

Intervention Type: DIETARY_SUPPLEMENT

placebo (for polyphenols)

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Overfeeding

Eligibility Criteria

Inclusion Criteria

• normal healthy male and female volunteer

Exclusion Criteria

• Diabetes mellitus
• High blood pressure
• Liver disease
• Kidney disease

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Lyon

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Francois Pralong

Full Professor and Head, Cervice of Endocrinology, Diabetology and Metabolism

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francois P Pralong, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

CHUVaudois

Lausanne, Canton of Vaud, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

François P Pralong, MD

Role: CONTACT

Francois.Pralong@chuv.ch

+41 21 314 0596

Facility Contacts

Weilin Kong, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 36386937 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35614978 (View on PubMed)

Other Identifiers

SNF 320030_141065

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

391/13

Identifier Type: -

Identifier Source: org_study_id