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 (NUTRILEAN +)

The main aim of the present study is to compare the effect of a 12-week physical activity program on body weight gain and body composition changes between normal weight and constitutionally lean individuals. The second objective will be to question the potential additional effect of a protein supplementation coupled to the physical training intervention on body wright and body composition in constitutionally lean women.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Normal Weight Women; Constitutionally Lean Women
• Intervention / Treatment: Behavioral: Physical training alone; Behavioral: physical training + protein intake

Detailed Description

After a medical inclusion visit, the participants will realize a maximal aerobic test at the university hospital as well as a body composition analysis, a blood sample will be taken, their resting metabolic rate will be assessed as well as their energy metabolism during a rectangular cycling exercise. Their muscle strength and architecture will be assessed. Their energy intake and eating habits will also be assessed as well as their diet-induced thermogenesis in response to a fixed and an ad libitum meal. Their sleep metabolism will also be assessed using the Dreem technology. Questionnaires will be used to evaluate their daily free living energy intake and accelerometers used to assess their daily physical activity level.

The participants will then perform a 12-week physical activity intervention with 15 of the 30 constitutionally lean one receiving a protein supplementation (randomly assigned). All the measures will be replicated at the end of the intervention as well as 6 weeks after

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Chu Clermont Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Inclusion criteria common to both groups

• 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)
• Able to give informed consent to participate in research.
• Affiliation to a Social Security scheme.

Inclusion criteria specific to women with constitutional thinness

• BMI ≤ 17.5 kg / m2
• Weight stable for at least 3 months
• No eating disorder
• No biological markers of undernutrition
• Absence of secondary amenorrhea

Inclusion criteria specific to normo-weighted subjects

• 20 kg / m2 ≤ BMI ≤ 25 kg / m2
• Weight stable for at least 3 months
• No eating disorder
• No biological markers of undernutrition
• Absence of secondary amenorrhea

Exclusion Criteria:

• Pregnant or breastfeeding woman
• Severe progressive disease
• Medical or surgical history judged by the investigator to be incompatible with this study
• Diabetes or any other pathology limiting the application of one or the other trial strategy
• History of cardiovascular and / or neuro-vascular pathology, and / or cardiovascular and / or neuro-vascular risk factors (excluding obesity / overweight)
• Surgical intervention in the previous 3 months
• Taking medications that may interfere with the results of the study
• Regular practice of intense physical activity (more than 3 physical activity sessions per week)
• Regular consumption of tobacco or alcohol
• Special diet
• Abnormal plasma levels of IGF-1, estradiol, free T3, cortisol and leptin (only for the "constitutional thinness" group)
• Persons under guardianship or subjects deprived of their liberty by judicial or administrative decision
• Person in a period of exclusion from another study
• Refusal of participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Normal weight; the normal weight women will receive the 12-week physical activity intervention and serve as a control group.	Behavioral: Physical training alone; 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.
Experimental: constitutionally lean women - Physical training only; women will receive the 12-week physical activity intervention	Behavioral: Physical training alone; 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.
Experimental: constitutionally lean women - Physical training + proteins; women will receive the 12-week physical activity intervention in addition to a protein supplementation	Behavioral: physical training + protein intake; 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. 15 women with constitutional leanness will, on top of the physical training, received a daily protein supplementation corresponding to 20 grams of proteins + 10 grams of Maltodextrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bone structure	the bone structure will be assessed thanks to DXA and pQCT	day 1, day 90, day 145
Change in muscle strength	muscle strength assessed thanks to isometric contraction using Biodex.	day 1, day 90, day 145
Change in muscle structure	muscle structure assessed thanks to muscle echography	day 1, day 90, day 145
Change in aerobic capacities .	aerobic capacities assessed using indirect calorimetry during a graded cycling exercise	day 1, day 90, day 145
Change in resting metabolic rate	resting metabolic rate assessed using indirect calorimetry during 30 minute rest in a comfortable inclined chair. The is the energy expended at rest in Kilo-Joules.	day 1, day 90, day 145
Change in Insulin	Insulin will be evaluated in blood sample	day 1, day 90, day 145
Change in glycaemia, .	glycaemia will be evaluated in blood sample	day 1, day 90, day 145
Change in triglycerides	triglycerides will be evaluated in blood sample	day 1, day 90, day 145
Change in cholesterol	cholesterol will be evaluated in blood sample	day 1, day 90, day 145
Change in leptin	leptin will be evaluated in blood sample	day 1, day 90, day 145
Change in ghrelin	ghrelin will be evaluated in blood sample	day 1, day 90, day 145
Change in adiponectin	adiponectin will be evaluated in blood sample	day 1, day 90, day 145
Change in thyroid hormones	thyroid hormones will be evaluated in blood sample	day 1, day 90, day 145
Change in LipoxMax	the point of maximal use of lipids during exercise will be assessed during a graded exercise composed of 4 stages of 6 minutes each, using indirect calorimetry.	day 1, day 90, day 145
Change in Energy intake	Energy Intake will be assessed using a Three-day dietary report (self-reported)	day 1, day 90, day 145
Change in physical activity level measured with an accelerometer	The time spent at low-moderate and vigorous physical activity will be assessed using a 7-day accelerometry record	day 1, day 90, day 145
Change in sleep metabolism assessed with the dreem technology captors	sleep metabolism assessed during a complete night, using the Dreem technology captors that consists in a simple band around the head during the night.	day 1, day 90, day 145

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): December 11, 2023

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: body composition; energy metabolism; physical training; constitutional leanness
• Additional Relevant MeSH Terms: Body Weight; Thinness
• Other Study ID Numbers: RBHP 2020 DUCLOS; 2020-A02565-34 (Other Identifier: 2020-A02565-34)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No