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CompletedNCT01224561SurnutritionUpdated May 5, 2011

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

An observational study in Lipid Overnutrition and Constitutional Thinness, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 3 sites in France. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-05-05.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
26
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Lipid Overnutrition
  • Constitutional Thinness

Keywords

  • Thinness
  • Leanness
  • healthy volunteers
  • Lipid metabolism disorder
03

In context

Thinness

66 studies on the registry are indexed under Thinness; 11 are open to participants now.

This study's planned enrollment of 26 is below the median of 275 across 22 observational studies indexed under Thinness.

Browse Thinness studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Constitutionnal thinness women and healthy volonteers(women)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • consent form the study signed
  • consent form for genetic study signed
  • normal laboratory values for liver enzymes, glucose, lipid

Exclusion criteria

Exclusion Criteria (common to the two groups):

  • pregnant
  • vegetarian
  • heavy smoking
  • heavy alcohol
  • depressive
  • taking hypolipidemic or antihypertensive drugs
  • dyslipidemia
05

Study design

Time perspective
Prospective
Enrollment
26 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Constitutional thinness

    Women with a a body mass index of less than 16.5 kg/m2

    Behavioral: Lipid overnutrition

  • Healthy Volonteer

    Women with a body mass index between 20 and 25 kg/m2

    Behavioral: Lipid overnutrition

Interventions

  • BehavioralLipid 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).

06

What researchers measure

Primary outcomes

  1. gene expression

    Level of genes (which regulate the lipid and energy metabolism) expression in fat and muscle tissues

    Time frame: After one month of lipid overnutrition

Secondary outcomes

  1. Anthropometric parameter

    Lean mass

    Time frame: After one month of lipid overnutrition

  2. Autonomic nervous system activity

    Heart rate variability analyses using ECG Holter monitoring

    Time frame: After one month of lipid overnutrition

  3. gastrointestinal hormone level

    Serum level of GLP1

    Time frame: After one month of lipid overnutrition

  4. Anthropometric parameter

    Weight

    Time frame: After one month of lipid overnutrition

  5. Anthropometric parameter

    Fat mass

    Time frame: After one month of lipid overnutrition

  6. gastrointestinal hormone level

    Serum level of ghréline

    Time frame: After one month of lipid overnutrition

  7. gastrointestinal hormone level

    Serum level of PYY

    Time frame: After one month of lipid overnutrition

07

Study locations

3 sites
  • CRNH Auvergne
    Clermont-Ferrand, 63000, France
  • CRNH Rhône-Alpes
    Lyon, 69000, France
  • CHU de Saint-Etienne
    Saint-etienne, 42055, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01224561
Collaborators
Ministry of Health, France
First posted
Oct 20, 2010
Start date
Mar 2008
Primary completion
Jan 2011
Completion
Jan 2011
Last update
May 5, 2011

Study contacts

Bruno ESTOUR, MD PhD
principal investigator · CHU de Saint-Etienne

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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