Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness

Constitutional Thinness Clinical Trial

— Surnutrition  

Official title:

Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224561
• Other study ID #: 0701047
• Secondary ID: 2007-A00744-49DG
• Status: Completed
• Phase: N/A
• First received: October 18, 2010
• Last updated: May 4, 2011
• Start date: March 2008
• Est. completion date: January 2011

Study information

• Verified date: May 2011
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection AuthorityFrance: Ministry of Health
• Study type: Observational

Clinical Trial Summary

For a given food intake, fat and energy metabolism in adipose tissue and muscle adapt to nutrient intakes. This adaptation to nutrition may be impaired in susceptible individuals or in obese patients by promoting weight gain, either in constitutional thinness (MC) by blocking it. The MC is a little known entity. These patients wish to grow for her and others. Can they? We have demonstrated abnormalities of hormones regulating appetite (ghrelin, PYY, GLP1 and leptin) that may participate in thinness. Furthermore, this thinness is associated with osteoporosis in 25% of true MC who is 25 years old.

Description:

This project aims to overfed MCs and follow the control parameters of energy metabolism. We will look for abnormalities in the adaptation to overnutrition in subjects with genetic background of thinness, which could explain the resistance to weight gain. The answer could possibly help to understand obesity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• consent form the study signed

• consent form for genetic study signed

• normal laboratory values for liver enzymes, glucose, lipid

Exclusion Criteria (common to the two groups):

• pregnant

• vegetarian

• heavy smoking

• heavy alcohol

• depressive

• taking hypolipidemic or antihypertensive drugs

• dyslipidemia

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Constitutional Thinness
• Lipid Overnutrition
• Overnutrition
• Thinness

Intervention

Behavioral:
• Lipid overnutrition
During 4 months, the daily caloric intake will be increased by about 70 g fat as butter 20 grams, 100 grams of cheese (Emmental) and 40 grams of almonds. This overnutrition corresponds to an excess of 760 kcal / day or 21,280 calories for the period and then taken to a theoretical 2.4 kg of fat (1 kg fat = 9000 kcal).

Locations

Country	Name	City	State
France	CRNH Auvergne	Clermont-Ferrand
France	CRNH Rhône-Alpes	Lyon
France	CHU de Saint-Etienne	Saint-etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gene expression	Level of genes (which regulate the lipid and energy metabolism) expression in fat and muscle tissues	After one month of lipid overnutrition	No
Secondary	Anthropometric parameter	Lean mass	After one month of lipid overnutrition	No
Secondary	Autonomic nervous system activity	Heart rate variability analyses using ECG Holter monitoring	After one month of lipid overnutrition	No
Secondary	gastrointestinal hormone level	Serum level of GLP1	After one month of lipid overnutrition	No
Secondary	Anthropometric parameter	Weight	After one month of lipid overnutrition	No
Secondary	Anthropometric parameter	Fat mass	After one month of lipid overnutrition	No
Secondary	gastrointestinal hormone level	Serum level of ghréline	After one month of lipid overnutrition	No
Secondary	gastrointestinal hormone level	Serum level of PYY	After one month of lipid overnutrition	No