Trials Sponsors Conditions Drugs Pricing

Conditions

Constitutionally Lean Women Healthy Normal Weight Women

Keywords

energy metabolismbody compositionphysical trainingconstitutional leanness

Outcome Measures

Primary Outcomes (3)

Change in body weight from baseline
body weight using a classical scale at different time : baseline, after the 12-week intervention and after 6 weeks of follow-up .
day 1, day 90, day 145
Change in fat mass composition
fat mass will be assessed using DXA
day 1, day 90, day 145
Change in fat free mass composition
fat free mass will be assessed using DXA
day 1, day 90, day 145

Secondary Outcomes (17)

Change in bone structure
day 1, day 90, day 145
Change in muscle strength
day 1, day 90, day 145
Change in muscle structure
day 1, day 90, day 145
Change in aerobic capacities .
day 1, day 90, day 145
Change in resting metabolic rate
day 1, day 90, day 145
+12 more secondary outcomes

Study Arms (3)

Normal weight

ACTIVE COMPARATOR

the normal weight women will receive the 12-week physical activity intervention and serve as a control group.

Behavioral: Physical training alone

constitutionally lean women - Physical training only

EXPERIMENTAL

women will receive the 12-week physical activity intervention

Behavioral: Physical training alone

constitutionally lean women - Physical training + proteins

EXPERIMENTAL

women will receive the 12-week physical activity intervention in addition to a protein supplementation

Interventions

Physical training aloneBehavioral

The physical activity intervention will consist in 12 weeks of training composed of 3 sessions per week. The three sessions will be mainly composed of resistance training aiming at increasing body weight through increased fat free mass. The main muscle groups (lower limbs, upper limbs and trunk) will be trained. The intervention will be performed under the supervision of a specialized coach.

Normal weightconstitutionally lean women - Physical training only

physical training + protein intakeBehavioral

Eligibility Criteria

Age18 Years - 35 Years

Sexfemale(Gender-based eligibility)

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Adult women aged 18 to 35, having a stable weight for at least 3 months.
Body mass index (BMI) ≤ 17.5 kg / m2 (for the "constitutional thinness" group) or 20 kg / m2 ≤ BMI ≤ 25 kg / m2 (for the normal-weighted control group)

Sponsors & Collaborators

University Hospital, Clermont-Ferrand
Otherlead

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Lise LaclautreCONTACTpromo_interne_drci@chu-clermontferrand.fr

Martine DUCLOSPRINCIPAL INVESTIGATOR

Study Officials

Martine DUCLOS
University Hospital, Clermont-Ferrand
PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963 promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 11, 2021

Study Start

May 1, 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

May 1, 2023

Estimated (date passed)

Management of Constitutional Thinness Through an Adapted Physical Activity Program, Whether or Not Associated With Food Supplementation. Interventional Study Compared to Matched Controls: NUTRILEAN + Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (17)

Study Arms (3)

Normal weight

constitutionally lean women - Physical training only

constitutionally lean women - Physical training + proteins

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (17)

Study Arms (3)

Normal weight

constitutionally lean women - Physical training only

constitutionally lean women - Physical training + proteins

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations