NCT01224561

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2008

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

May 5, 2011

Status Verified

May 1, 2011

Enrollment Period

2.8 years

First QC Date

October 18, 2010

Last Update Submit

May 4, 2011

Conditions

Lipid OvernutritionConstitutional Thinness

Keywords

ThinnessLeannesshealthy volunteersLipid metabolism disorder

Outcome Measures

Primary Outcomes (1)

  • gene expression

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

    After one month of lipid overnutrition

Secondary Outcomes (7)

  • Anthropometric parameter

    After one month of lipid overnutrition

  • Autonomic nervous system activity

    After one month of lipid overnutrition

  • gastrointestinal hormone level

    After one month of lipid overnutrition

  • Anthropometric parameter

    After one month of lipid overnutrition

  • Anthropometric parameter

    After one month of lipid overnutrition

  • +2 more secondary outcomes

Study Arms (2)

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

Lipid overnutritionBEHAVIORAL

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 thinnessHealthy Volonteer

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Constitutionnal thinness women and healthy volonteers(women)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CRNH Auvergne

Clermont-Ferrand, 63000, France

Location

CRNH Rhône-Alpes

Lyon, 69000, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

muscle tissue fat tissue

MeSH Terms

Conditions

ThinnessLipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Bruno ESTOUR, MD PhD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 20, 2010

Study Start

March 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

May 5, 2011

Record last verified: 2011-05

Locations

FR(3)