Lipid OvernutritionSurnutritionNCT01224561
Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness
An observational study of Lipid Overnutrition and Constitutional Thinness, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lipid Overnutrition, Constitutional Thinness
- What is being tested?
- Lipid overnutrition
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 26 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2008to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Constitutionnal thinness women and healthy volonteers(women)
Who may be able to join
- consent form the study signed
- consent form for genetic study signed
- normal laboratory values for liver enzymes, glucose, lipid
Who cannot join
- pregnant
- vegetarian
- heavy smoking
- heavy alcohol
- depressive
- taking hypolipidemic or antihypertensive drugs
- dyslipidemia
Trial locations and contacts
3 sites in 1 country.
France3 sites
CRNH Auvergne
Clermont-Ferrand, 63000
CRNH Rhône-Alpes
Lyon, 69000
CHU de Saint-Etienne
Saint-Etienne, 42055
About this study
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.
- Conditions
- Lipid Overnutrition, Constitutional Thinness
- Being tested
- Lipid overnutrition
- Keywords
- Thinness, Leanness, healthy volunteers, Lipid metabolism disorder
- Medical subject headings
- Thinness, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid overnutritionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Constitutional thinness | Women with a a body mass index of less than 16.5 kg/m2 Receives: Behavioral: Lipid overnutrition | |
| Healthy Volonteer | Women with a body mass index between 20 and 25 kg/m2 Receives: Behavioral: Lipid overnutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
gene expression
Level of genes (which regulate the lipid and energy metabolism) expression in fat and muscle tissues
Measured: After one month of lipid overnutrition
Secondary outcomes (7)
Anthropometric parameter
Lean mass
Measured: After one month of lipid overnutrition
Autonomic nervous system activity
Heart rate variability analyses using ECG Holter monitoring
Measured: After one month of lipid overnutrition
gastrointestinal hormone level
Serum level of GLP1
Measured: After one month of lipid overnutrition
Anthropometric parameter
Weight
Measured: After one month of lipid overnutrition
Anthropometric parameter
Fat mass
Measured: After one month of lipid overnutrition
gastrointestinal hormone level
Serum level of ghréline
Measured: After one month of lipid overnutrition
gastrointestinal hormone level
Serum level of PYY
Measured: After one month of lipid overnutrition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startMar 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid OvernutritionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Investigators
- Bruno ESTOUR, MD PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224561
- Sponsor's protocol ID
- 0701047
- Other IDs
- 2007-A00744-49, DGS2007-0536
- Acronym
- Surnutrition
- Status last verified
- May 2011
- First submitted
- 18 Oct 2010
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness
- ClinicalTrials.gov ID
- NCT01224561
- Acronym / sponsor ID
- Surnutrition / 0701047
- Conditions
- Lipid Overnutrition, Constitutional Thinness
- Keywords
- Thinness, Leanness, healthy volunteers, Lipid metabolism disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Mar 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constitutional thinness | – | Behavioral: Lipid overnutritionWomen with a a body mass index of less than 16.5 kg/m2 |
| Healthy Volonteer | – | Behavioral: Lipid overnutritionWomen with a body mass index between 20 and 25 kg/m2 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Constitutionnal thinness women and healthy volonteers(women)
Key inclusion criteria (3 listed)
- consent form the study signed
- consent form for genetic study signed
- normal laboratory values for liver enzymes, glucose, lipid
Key exclusion criteria (7 listed)
- pregnant
- vegetarian
- heavy smoking
- heavy alcohol
- depressive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipid overnutritionDuring 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). | Behavioural | Constitutional thinness, Healthy Volonteer |
Primary outcome
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
7 secondary outcomes
Anthropometric parameter
Time frame: After one month of lipid overnutrition
Autonomic nervous system activity
Time frame: After one month of lipid overnutrition
gastrointestinal hormone level
Time frame: After one month of lipid overnutrition
Anthropometric parameter
Time frame: After one month of lipid overnutrition
Anthropometric parameter
Time frame: After one month of lipid overnutrition
gastrointestinal hormone level
Time frame: After one month of lipid overnutrition
gastrointestinal hormone level
Time frame: After one month of lipid overnutrition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno ESTOUR, MD PhD principal investigator
CHU de Saint-Etienne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipid Overnutrition and Constitutional Thinness, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gene expression (time frame: After one month of lipid overnutrition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2011.