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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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04749706
Acronym
NUTRILEAN +
Enrollment
45
Registered
2021-02-11
Start date
2021-05-01
Completion date
2023-12-11
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constitutionally Lean Women, Healthy Normal Weight Women

Keywords

energy metabolism, body composition, physical training, constitutional leanness

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

Interventions

BEHAVIORALPhysical 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.

BEHAVIORALphysical 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

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change in aerobic capacities .day 1, day 90, day 145aerobic capacities assessed using indirect calorimetry during a graded cycling exercise
Change in resting metabolic rateday 1, day 90, day 145resting 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.
Change in Insulinday 1, day 90, day 145Insulin will be evaluated in blood sample
Change in glycaemia, .day 1, day 90, day 145glycaemia will be evaluated in blood sample
Change in triglyceridesday 1, day 90, day 145triglycerides will be evaluated in blood sample
Change in cholesterolday 1, day 90, day 145cholesterol will be evaluated in blood sample
Change in leptinday 1, day 90, day 145leptin will be evaluated in blood sample
Change in bone structureday 1, day 90, day 145the bone structure will be assessed thanks to DXA and pQCT
Change in adiponectinday 1, day 90, day 145adiponectin will be evaluated in blood sample
Change in thyroid hormonesday 1, day 90, day 145thyroid hormones will be evaluated in blood sample
Change in LipoxMaxday 1, day 90, day 145the 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.
Change in Energy intakeday 1, day 90, day 145Energy Intake will be assessed using a Three-day dietary report (self-reported)
Change in physical activity level measured with an accelerometerday 1, day 90, day 145The time spent at low-moderate and vigorous physical activity will be assessed using a 7-day accelerometry record
Change in sleep metabolism assessed with the dreem technology captorsday 1, day 90, day 145sleep metabolism assessed during a complete night, using the Dreem technology captors that consists in a simple band around the head during the night.
Change in ghrelinday 1, day 90, day 145ghrelin will be evaluated in blood sample
Change in muscle strengthday 1, day 90, day 145muscle strength assessed thanks to isometric contraction using Biodex.
Change in muscle structureday 1, day 90, day 145muscle structure assessed thanks to muscle echography

Countries

France

Contacts

Primary ContactLise Laclautre
promo_interne_drci@chu-clermontferrand.fr334.73.754.963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026