Study of the Mechanisms of Metabolic Adaptations to Overfeeding

Obesity Clinical Trial

— Polynut  

Official title:

Study of the Determinants and Mechanisms of Adaptation of Metabolic Responses to Controlled Overfeeding in Female and Male Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02225457
• Other study ID #: 391/13
• Secondary ID: SNF 320030_14106
• Status: Recruiting
• Phase: N/A
• First received: July 21, 2014
• Last updated: March 5, 2016
• Start date: December 2013
• Est. completion date: January 2017

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: François P Pralong, MD
• Phone: +41 21 314 0596
• Email: Francois.Pralong[@]chuv.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: January 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• normal healthy male and female volunteer

Exclusion Criteria:

• Diabetes mellitus

• High blood pressure

• Liver disease

• Kidney disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Other:
• 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.

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

Locations

Country	Name	City	State
Switzerland	CHUVaudois	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois	University of Lyon

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in insulin sensitivity	Whole body insulin sensitivity will be measured during hyperinsulinemic, euglycemic clamps.	baseline, day 31 of overfeeding	No
Secondary	Change from baseline in muscle and adipose tissue gene expression	Transcriptomic experiments will be performed on muscle and adipose tissue samples	Baseline, day 28 of overfeeding	No