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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01224561
First received: October 18, 2010
Last updated: May 4, 2011
Last verified: May 2011

October 18, 2010
May 4, 2011
March 2008
January 2011   (final data collection date for primary outcome measure)
gene expression [ Time Frame: After one month of lipid overnutrition ] [ Designated as safety issue: No ]
Level of genes (which regulate the lipid and energy metabolism) expression in fat and muscle tissues
Same as current
Complete list of historical versions of study NCT01224561 on ClinicalTrials.gov Archive Site
  • Anthropometric parameter [ Time Frame: After one month of lipid overnutrition ] [ Designated as safety issue: No ]
    Lean mass
  • Autonomic nervous system activity [ Time Frame: After one month of lipid overnutrition ] [ Designated as safety issue: No ]
    Heart rate variability analyses using ECG Holter monitoring
  • gastrointestinal hormone level [ Time Frame: After one month of lipid overnutrition ] [ Designated as safety issue: No ]
    Serum level of GLP1
  • Anthropometric parameter [ Time Frame: After one month of lipid overnutrition ] [ Designated as safety issue: No ]
    Weight
  • Anthropometric parameter [ Time Frame: After one month of lipid overnutrition ] [ Designated as safety issue: No ]
    Fat mass
  • gastrointestinal hormone level [ Time Frame: After one month of lipid overnutrition ] [ Designated as safety issue: No ]
    Serum level of ghréline
  • gastrointestinal hormone level [ Time Frame: After one month of lipid overnutrition ] [ Designated as safety issue: No ]
    Serum level of PYY
Same as current
Not Provided
Not Provided
 
Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness
Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

muscle tissue fat tissue

Non-Probability Sample

Constitutionnal thinness women and healthy volonteers(women)

  • Lipid Overnutrition
  • Constitutional Thinness
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).
  • Constitutional thinness
    Women with a a body mass index of less than 16.5 kg/m2
    Intervention: Behavioral: Lipid overnutrition
  • Healthy Volonteer
    Women with a body mass index between 20 and 25 kg/m2
    Intervention: Behavioral: Lipid overnutrition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01224561
0701047, 2007-A00744-49, DGS2007-0536
No
Clément CAILLAUX, Centre Hospitalier Universitaire de Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Principal Investigator: Bruno ESTOUR, MD PhD CHU de Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP