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

NCT ID: NCT04749706

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-12-11

Brief Summary

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.

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

Conditions

Healthy Normal Weight Women; Constitutionally Lean Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal weight

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

Group Type: ACTIVE_COMPARATOR

Physical training alone

Intervention Type: BEHAVIORAL

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.

constitutionally lean women - Physical training only

women will receive the 12-week physical activity intervention

Group Type: EXPERIMENTAL

Physical training alone

Intervention Type: BEHAVIORAL

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.

constitutionally lean women - Physical training + proteins

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

Group Type: EXPERIMENTAL

physical training + protein intake

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martine DUCLOS

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

Chu Clermont Ferrand

Clermont-Ferrand, , France

Countries

France

Central Contacts

Lise Laclautre

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

334.73.754.963

Facility Contacts

Lise Laclautre

Role: primary

promo_interne_drci@chu-clermontferrand.fr

Other Identifiers

2020-A02565-34

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2020 DUCLOS

Identifier Type: -

Identifier Source: org_study_id