NCT04749706

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-05-01
• Completion: 2023-12-11
• First posted: 2021-02-11
• Last updated: 2021-05-03

Locations

1 site across 1 country: France