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OpenTrials
Completed

NCT Number: NCT01224561

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.

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Key information

Conditions

Lipid Overnutrition Body Weight Constitutional Thinness Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

CRNH Auvergne, Clermont-Ferrand, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lipid overnutrition

Behavioral

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).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Acronym: Surnutrition

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 20, 2010
Registry last updated
May 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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