Individuals With Constitutional ThinnessNCT02004821
Clinical Trial in Constitutional Thinness
A study testing Renutryl® Booster, an oral nutritional supplement in a 300 ml bottle (600 kcal, 30 g protein, 72 g carbohydrate, 21 g fat). One bottle per day during 14 days. in people with Individuals With Constitutional Thinness, run by Société des Produits Nestlé (SPN) at 1 site in France.
Trial summary
The purpose of this study is to evaluate the molecular differences between a group of Constitutionally Thin (CT) subjects and a group of controls. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Individuals With Constitutional Thinness
- What is being tested?
- Renutryl® Booster, an oral nutritional supplement in a 300 ml bottle (600 kcal, 30 g protein, 72 g carbohydrate, 21 g fat). One bottle per day during 14 days.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to May 2016
- Phase
- Interventional
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Inclusion criteria specific to subjects with constitutional thinness
- Women: BMI less or equal to 17.5
- Men: BMI less or equal to 18.5
- Stable weight for at least 3 months
- Men and women: BMI above or equal to 20 but not more than 25
- Stable weight for at least 3 months
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- No previous family history of first or second-degree obesity
- Age: between 18 and 35 at the inclusion visit
- Normal blood sugar, liver function, lipid and coagulation profiles
- Signed consent form to participate in the study
- Signed consent form for genetic analysis
- Acceptance of a moderate weight gain of 2 kg (less than 10% of body weight)
- Beneficiary or member of a social security system.
Who cannot join
- Adults with a legal guardian, or subjects unable to act freely due to a decision by a legal or administrative authority,
- Pregnancy in the case of women
- Women without contraception
- Vegetarian subjects or those with lactose intolerance
- Subjects with an eating disorder (DSM IV)
- Significant alcohol consumption equivalent to more than 10 glasses of wine per week
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- Severe progressive disorder (diabetes, for example)
- Subjects who undertake intensive physical activity (more than 3 sessions of physical activity per week)
- Significant tobacco consumption equivalent to more than 10 cigarettes per day
- Depression or psychiatric condition (treated with antidepressant or psychotropic medication), depression questionnaire/score
- Medical or surgical history considered by the investigator to be incompatible with this study (stomach or intestinal surgery, for example)
- Subjects receiving treatment that may interfere with the parameters measured: antihypertensives (blockers, centrally acting antihypertensives), anti-hyperlipidemic agents or corticosteroids for more than 8 days
- Inclusion in a different clinical study within the previous 12 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Génomique de la résistance à la Prise de Poids Dans la Maigreur Constitutionnelle
The purpose of this study is to evaluate the molecular differences between a group of Constitutionally Thin (CT) subjects and a group of controls.
- Conditions
- Individuals With Constitutional Thinness
- Being tested
- Renutryl® Booster, an oral nutritional supplement in a 300 ml bottle (600 kcal, 30 g protein, 72 g carbohydrate, 21 g fat). One bottle per day during 14 days.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renutryl® Booster, an oral nutritional supplement in a 300 ml bottle (600 kcal, 30 g protein, 72 g carbohydrate, 21 g fat). One bottle per day during 14 days.Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Renutryl® Booster | Experimental | Renutryl® Booster, an oral nutritional supplement in a 300 ml bottle (600 kcal, 30 g protein, 72 g carbohydrate, 21 g fat). Receives: Dietary Supplement: Renutryl® Booster, an oral nutritional supplement in a 300 ml bottle (600 kcal, 30 g protein, 72 g carbohydrate, 21 g fat). One bottle per day during 14 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular differences (evaluated in plasma, fat and muscle biopsies, urines) between a group of CT subjects and a control group before, during and after 14 days of overnutrition
Molecular analyses of plasma, fat and muscle biopsies and urine
Measured: 6 weeks
Secondary outcomes (1)
Metabolic, anthropometric, histological, and microbiome differences between a group of CT subjects and a control group before, during, and after 14 days of overnutrition
- Metabolic differences (eg: lipids, amino-acids… in plasma and urine)
- Anthropometric differences (eg: weight, BMI, waist/ hip ratio)
- Histological (eg: muscle and fat tissue biopsies)
- Inflammation and metabolism specific marker differences
- Energy metabolism differences (eg: RER, RQ, Cox, Lox…)
- Bone quality differences (eg: bone mineral density)
- Microbiome differences
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Individuals With Constitutional ThinnessStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruno Estour, Prof., Principal investigator, CHU de Saint-Étienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004821
- Sponsor's protocol ID
- 12.17.NIHS
- Status last verified
- Sep 2016
- First submitted
- 15 Nov 2013
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cominetti O, Nunez Galindo A, Corthesy J, Carayol J, Germain N, Galusca B, Estour B, Hager J, Gheldof N, Dayon L. Proteomics reveals unique plasma signatures in constitutional thinness. Proteomics Clin Appl. 2022 Sep;16(5):e2100114. doi: 10.1002/prca.202100114. Epub 2022 May 26.
PubMed 35579096Bailly M, Germain N, Feasson L, Costes F, Estour B, Hourde C, N Merlet A, Thomas T, Hager J, Pereira B, Thivel D, Courteix D, Galusca B, Verney J. Skeletal muscle of females and males with constitutional thinness: a low intramuscular lipid content and oxidative profile. Appl Physiol Nutr Metab. 2020 Nov;45(11):1287-1298. doi: 10.1139/apnm-2020-0068. Epub 2020 Jun 1.
PubMed 32479741Ling Y, Galusca B, Martin FP, Bartova S, Carayol J, Moco S, Epelbaum J, Grouselle D, Boirie Y, Montaurier C, Cuenco J, Minnion JS, Thomas T, Mure S, Hager J, Estour B, Gheldof N, Germain N. Resistance to lean mass gain in constitutional thinness in free-living conditions is not overpassed by overfeeding. J Cachexia Sarcopenia Muscle. 2020 Oct;11(5):1187-1199. doi: 10.1002/jcsm.12572. Epub 2020 Apr 10.
PubMed 32274897Ling Y, Carayol J, Galusca B, Canto C, Montaurier C, Matone A, Vassallo I, Minehira K, Alexandre V, Cominetti O, Nunez Galindo A, Corthesy J, Dayon L, Charpagne A, Metairon S, Raymond F, Descombes P, Casteillo F, Peoc'h M, Palaghiu R, Feasson L, Boirie Y, Estour B, Hager J, Germain N, Gheldof N. Persistent low body weight in humans is associated with higher mitochondrial activity in white adipose tissue. Am J Clin Nutr. 2019 Sep 1;110(3):605-616. doi: 10.1093/ajcn/nqz144.
PubMed 31374571
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Génomique de la résistance à la Prise de Poids Dans la Maigreur Constitutionnelle
- ClinicalTrials.gov ID
- NCT02004821
- Acronym / sponsor ID
- 12.17.NIHS
- Conditions
- Individuals With Constitutional Thinness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 9 Dec 2013 (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.
The purpose of this study is to evaluate the molecular differences between a group of Constitutionally Thin (CT) subjects and a group of controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renutryl® Booster | Experimental | Dietary Supplement: Renutryl® Booster, an oral nutritional supplement in a 300 ml bottle (600 kcal, 30 g protein, 72 g carbohydrate, 21 g fat). One bottle per day during 14 days.Renutryl® Booster, an oral nutritional supplement in a 300 ml bottle (600 kcal, 30 g protein, 72 g carbohydrate, 21 g fat). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Inclusion criteria specific to subjects with constitutional thinness
- Women: BMI less or equal to 17.5
- Men: BMI less or equal to 18.5
- Stable weight for at least 3 months
- Men and women: BMI above or equal to 20 but not more than 25
Key exclusion criteria (13 listed)
- Adults with a legal guardian, or subjects unable to act freely due to a decision by a legal or administrative authority,
- Pregnancy in the case of women
- Women without contraception
- Vegetarian subjects or those with lactose intolerance
- Subjects with an eating disorder (DSM IV)
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 |
|---|---|---|
| Renutryl® Booster, an oral nutritional supplement in a 300 ml bottle (600 kcal, 30 g protein, 72 g carbohydrate, 21 g fat). One bottle per day during 14 days. | Dietary supplement | Renutryl® Booster |
Primary outcome
Molecular differences (evaluated in plasma, fat and muscle biopsies, urines) between a group of CT subjects and a control group before, during and after 14 days of overnutrition
Time frame: 6 weeks
Molecular analyses of plasma, fat and muscle biopsies and urine
1 secondary outcome
Metabolic, anthropometric, histological, and microbiome differences between a group of CT subjects and a control group before, during, and after 14 days of overnutrition
Time frame: 6 weeks
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 28 Sep 2016.
- Derived from this study: PubMed 35579096Cominetti O, Nunez Galindo A, Corthesy J, Carayol J, Germain N, Galusca B, Estour B, Hager J, Gheldof N, Dayon L. Proteomics reveals unique plasma signatures in constitutional thinness. Proteomics Clin Appl. 2022 Sep;16(5):e2100114. doi: 10.1002/prca.202100114. Epub 2022 May 26.
- Derived from this study: PubMed 32479741Bailly M, Germain N, Feasson L, Costes F, Estour B, Hourde C, N Merlet A, Thomas T, Hager J, Pereira B, Thivel D, Courteix D, Galusca B, Verney J. Skeletal muscle of females and males with constitutional thinness: a low intramuscular lipid content and oxidative profile. Appl Physiol Nutr Metab. 2020 Nov;45(11):1287-1298. doi: 10.1139/apnm-2020-0068. Epub 2020 Jun 1.
- Derived from this study: PubMed 32274897Ling Y, Galusca B, Martin FP, Bartova S, Carayol J, Moco S, Epelbaum J, Grouselle D, Boirie Y, Montaurier C, Cuenco J, Minnion JS, Thomas T, Mure S, Hager J, Estour B, Gheldof N, Germain N. Resistance to lean mass gain in constitutional thinness in free-living conditions is not overpassed by overfeeding. J Cachexia Sarcopenia Muscle. 2020 Oct;11(5):1187-1199. doi: 10.1002/jcsm.12572. Epub 2020 Apr 10.
- Derived from this study: PubMed 31374571Ling Y, Carayol J, Galusca B, Canto C, Montaurier C, Matone A, Vassallo I, Minehira K, Alexandre V, Cominetti O, Nunez Galindo A, Corthesy J, Dayon L, Charpagne A, Metairon S, Raymond F, Descombes P, Casteillo F, Peoc'h M, Palaghiu R, Feasson L, Boirie Y, Estour B, Hager J, Germain N, Gheldof N. Persistent low body weight in humans is associated with higher mitochondrial activity in white adipose tissue. Am J Clin Nutr. 2019 Sep 1;110(3):605-616. doi: 10.1093/ajcn/nqz144.
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, Prof. principal investigator
CHU de Saint-Étienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renutryl® Booster, an oral nutritional supplement in a 300 ml bottle (600 kcal, 30 g protein, 72 g carbohydrate, 21 g fat). One bottle per day during 14 days. in people with Individuals With Constitutional Thinness, run by Société des Produits Nestlé (SPN) at 1 site 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 13 inclusion and 13 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 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Molecular differences (evaluated in plasma, fat and muscle biopsies, urines) between a group of CT subjects and a control group before, during and after 14 days of overnutrition (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02004821, which also lists 4 linked publications.
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 28 Sep 2016; AzTrials last refreshed its copy on 29 Oct 2026.