An interventional study of Hypercaloric diet and polyphenols in Obesity and Diabetes, sponsored by Centre Hospitalier Universitaire Vaudois. Status unknown at 1 site in Switzerland. Open to participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-08.
Sponsored by Centre Hospitalier Universitaire Vaudois · Not applicable, Interventional, and Basic science
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 52 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.
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Exclusion Criteria:
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.
Other: Hypercaloric diet · Dietary Supplement: 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. Overfeeding will consist in a hypercaloric diet providing an excess of 50% KCal over daily requirements, and will last 30 days.
Other: Hypercaloric diet · Dietary Supplement: placebo (for polyphenols)
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.
Also known as: Overfeeding
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.
Change from baseline in insulin sensitivity
Whole body insulin sensitivity will be measured during hyperinsulinemic, euglycemic clamps.
Time frame: baseline, day 31 of overfeeding
Change from baseline in muscle and adipose tissue gene expression
Transcriptomic experiments will be performed on muscle and adipose tissue samples
Time frame: Baseline, day 28 of overfeeding
This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Vaudois