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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00905892
Other study ID # CRNHRA-09-002
Secondary ID
Status Completed
Phase N/A
First received May 20, 2009
Last updated June 22, 2011
Start date September 2005
Est. completion date March 2010

Study information

Verified date June 2011
Source Centre de Recherche en Nutrition Humaine Rhone-Alpe
Contact n/a
Is FDA regulated No
Health authority France: Direction Générale de la Santé
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the partitioning of exogenous lipids in the postprandial period while a study of overfeeding. The method is based on the incorporation of a stable isotopic tracer (d31_palmitic acid, d31_C16) in lipoprotein triglycerides (TG-CHYLOMICRON and TG-VLDL) and in free fatty acids (FFA).


Description:

Healthy overweight and lean young men are subjected to an overfeeding during 56 days which corresponds to a supplement of 761 Kcal/day. During two exploration days (before : D0 et after : D56 overfeeding) they have ingested a breakfast with tracer (d31_palmitic acid, d31_C16, 20mg/kg) and blood and urine samples were collected every hour of each exploration day. The enrichment in deuterium was measured by gas chromatography-organic mass spectrometry (GC-OMS) in palmitic acid pool of lipid fractions.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 2010
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- 18 to 55 years old

- BMI 18 to 30 kg/m²

- Stable physical activity

- Safety subject during medical consultation

Exclusion Criteria:

- Medical or surgical history which may affect energy expenditure (renal -cardiovascular -hepatic- endocrine-inflammatory diseases)

- Drug use that could affect energy expenditure (steroids, nicotine substitutes, thyroid hormones)

- Eating disorder

- Intensive sportive activity

- Subjects who Smoke

- Claustrophobic subjects

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Hyperlipidic overfeeding
100g per day of cheese + 40g per day of almonds + 20g per day of butter

Locations

Country Name City State
France Centre de recherche en nutrition humaine Rhone-Alpes Pierre-Bénite

Sponsors (2)

Lead Sponsor Collaborator
Centre de Recherche en Nutrition Humaine Rhone-Alpe Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post prandial partitioning of exogenous lipids Before and after overfeeding No
Secondary Genes expression in adipose and muscle tissues Before and after overfeeding No
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