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

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ClinicalTrials.gov Identifier: NCT01224561
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : May 5, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Lipid Overnutrition Constitutional Thinness Behavioral: Lipid overnutrition

Detailed 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.

Study Design

Study Type : Observational
Estimated Enrollment : 26 participants
Time Perspective: Prospective
Official Title: Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness
Study Start Date : March 2008
Primary Completion Date : January 2011
Study Completion Date : January 2011
Groups and Cohorts

Group/Cohort Intervention/treatment
Constitutional thinness
Women with a a body mass index of less than 16.5 kg/m2
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).
Healthy Volonteer
Women with a body mass index between 20 and 25 kg/m2
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).


Outcome Measures

Primary Outcome Measures :
  1. gene expression [ Time Frame: After one month of lipid overnutrition ]
    Level of genes (which regulate the lipid and energy metabolism) expression in fat and muscle tissues


Secondary Outcome Measures :
  1. Anthropometric parameter [ Time Frame: After one month of lipid overnutrition ]
    Lean mass

  2. Autonomic nervous system activity [ Time Frame: After one month of lipid overnutrition ]
    Heart rate variability analyses using ECG Holter monitoring

  3. gastrointestinal hormone level [ Time Frame: After one month of lipid overnutrition ]
    Serum level of GLP1

  4. Anthropometric parameter [ Time Frame: After one month of lipid overnutrition ]
    Weight

  5. Anthropometric parameter [ Time Frame: After one month of lipid overnutrition ]
    Fat mass

  6. gastrointestinal hormone level [ Time Frame: After one month of lipid overnutrition ]
    Serum level of ghréline

  7. gastrointestinal hormone level [ Time Frame: After one month of lipid overnutrition ]
    Serum level of PYY


Biospecimen Retention:   Samples With DNA
muscle tissue fat tissue

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Constitutionnal thinness women and healthy volonteers(women)
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224561


Locations
France
CRNH Auvergne
Clermont-Ferrand, France, 63000
CRNH Rhône-Alpes
Lyon, France, 69000
CHU de Saint-Etienne
Saint-etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Principal Investigator: Bruno ESTOUR, MD PhD CHU de Saint-Etienne
More Information

Responsible Party: Clément CAILLAUX, Centre Hospitalier Universitaire de Saint-Etienne
ClinicalTrials.gov Identifier: NCT01224561     History of Changes
Other Study ID Numbers: 0701047
2007-A00744-49 ( Other Identifier: Afssaps )
DGS2007-0536 ( Other Identifier: DGS )
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: May 5, 2011
Last Verified: May 2011

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Thinness
Leanness
healthy volunteers
Lipid metabolism disorder

Additional relevant MeSH terms:
Overnutrition
Thinness
Nutrition Disorders
Body Weight
Signs and Symptoms