Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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 Intervention
Lipid Overnutrition
Constitutional Thinness
Behavioral: Lipid overnutrition

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA

muscle tissue fat tissue


Estimated Enrollment: 26
Study Start Date: March 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, DGS2007-0536
Study First Received: October 18, 2010
Last Updated: May 4, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority
France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 23, 2014