Clinical Trial in Constitutional Thinness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-05-31

Brief Summary

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The purpose of this study is to evaluate the molecular differences between a group of Constitutionally Thin (CT) subjects and a group of controls.

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Detailed Description

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Conditions

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Individuals With Constitutional Thinness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Renutryl® Booster

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

Group Type EXPERIMENTAL

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.

Intervention Type DIETARY_SUPPLEMENT

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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
* 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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes