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Clinical Trial in Constitutional Thinness

Primary Purpose

Individuals With Constitutional Thinness

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
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.
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Individuals With Constitutional Thinness

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Inclusion criteria specific to subjects with normal weight

  • Men and women: BMI above or equal to 20 but not more than 25
  • Stable weight for at least 3 months
  • No previous family history of first or second-degree obesity

Inclusion criteria common to both groups

  • 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.

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • CHU de Saint-Étienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renutryl® Booster

Arm Description

Renutryl® Booster, an oral nutritional supplement in a 300 ml bottle (600 kcal, 30 g protein, 72 g carbohydrate, 21 g fat).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 15, 2013
Last Updated
September 27, 2016
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT02004821
Brief Title
Clinical Trial in Constitutional Thinness
Official Title
Génomique de la résistance à la Prise de Poids Dans la Maigreur Constitutionnelle
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Individuals With Constitutional Thinness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renutryl® Booster
Arm Type
Experimental
Arm Description
Renutryl® Booster, an oral nutritional supplement in a 300 ml bottle (600 kcal, 30 g protein, 72 g carbohydrate, 21 g fat).
Intervention Type
Dietary Supplement
Intervention Name(s)
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.
Primary Outcome Measure Information:
Title
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
Description
Molecular analyses of plasma, fat and muscle biopsies and urine
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Metabolic, anthropometric, histological, and microbiome differences between a group of CT subjects and a control group before, during, and after 14 days of overnutrition
Description
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
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Inclusion criteria specific to subjects with normal weight Men and women: BMI above or equal to 20 but not more than 25 Stable weight for at least 3 months No previous family history of first or second-degree obesity Inclusion criteria common to both groups 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. Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Estour, Prof.
Organizational Affiliation
CHU de Saint-Étienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Étienne
City
St-Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35579096
Citation
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.
Results Reference
derived
PubMed Identifier
32479741
Citation
Bailly 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.
Results Reference
derived
PubMed Identifier
32274897
Citation
Ling 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.
Results Reference
derived
PubMed Identifier
31374571
Citation
Ling 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.
Results Reference
derived

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Clinical Trial in Constitutional Thinness

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