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Study of the Mechanisms of Metabolic Adaptations to Overfeeding

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02225457
Acronym
Polynut
Enrollment
52
Registered
2014-08-26
Start date
2013-12-31
Completion date
2017-01-31
Last updated
2016-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Diabetes

Keywords

insulin resistance, type 2 diabetes, obesity, polyphenols, adipose tissue, overfeeding

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.

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.

DIETARY_SUPPLEMENTpolyphenols

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

DIETARY_SUPPLEMENTplacebo (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.

Sponsors

University of Lyon
CollaboratorOTHER
Centre Hospitalier Universitaire Vaudois
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* normal healthy male and female volunteer

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in insulin sensitivitybaseline, day 31 of overfeedingWhole body insulin sensitivity will be measured during hyperinsulinemic, euglycemic clamps.

Secondary

MeasureTime frameDescription
Change from baseline in muscle and adipose tissue gene expressionBaseline, day 28 of overfeedingTranscriptomic experiments will be performed on muscle and adipose tissue samples

Countries

Switzerland

Contacts

Primary ContactFrançois P Pralong, MD
Francois.Pralong@chuv.ch+41 21 314 0596

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026