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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 (NUTRILEAN +)

Primary Purpose

Healthy Normal Weight Women, Constitutionally Lean Women

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical training alone
physical training + protein intake
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Normal Weight Women focused on measuring energy metabolism, body composition, physical training, constitutional leanness

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Chu Clermont Ferrand

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Normal weight

constitutionally lean women - Physical training only

constitutionally lean women - Physical training + proteins

Arm Description

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

women will receive the 12-week physical activity intervention

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

Outcomes

Primary Outcome Measures

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 .
Change in fat mass composition
fat mass will be assessed using DXA
Change in fat free mass composition
fat free mass will be assessed using DXA

Secondary Outcome Measures

Change in bone structure
the bone structure will be assessed thanks to DXA and pQCT
Change in muscle strength
muscle strength assessed thanks to isometric contraction using Biodex.
Change in muscle structure
muscle structure assessed thanks to muscle echography
Change in aerobic capacities .
aerobic capacities assessed using indirect calorimetry during a graded cycling exercise
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.
Change in Insulin
Insulin will be evaluated in blood sample
Change in glycaemia, .
glycaemia will be evaluated in blood sample
Change in triglycerides
triglycerides will be evaluated in blood sample
Change in cholesterol
cholesterol will be evaluated in blood sample
Change in leptin
leptin will be evaluated in blood sample
Change in ghrelin
ghrelin will be evaluated in blood sample
Change in adiponectin
adiponectin will be evaluated in blood sample
Change in thyroid hormones
thyroid hormones will be evaluated in blood sample
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.
Change in Energy intake
Energy Intake will be assessed using a Three-day dietary report (self-reported)
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
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.

Full Information

First Posted
February 4, 2021
Last Updated
April 28, 2021
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT04749706
Brief Title
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
Acronym
NUTRILEAN +
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
December 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Normal Weight Women, Constitutionally Lean Women
Keywords
energy metabolism, body composition, physical training, constitutional leanness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal weight
Arm Type
Active Comparator
Arm Description
the normal weight women will receive the 12-week physical activity intervention and serve as a control group.
Arm Title
constitutionally lean women - Physical training only
Arm Type
Experimental
Arm Description
women will receive the 12-week physical activity intervention
Arm Title
constitutionally lean women - Physical training + proteins
Arm Type
Experimental
Arm Description
women will receive the 12-week physical activity intervention in addition to a protein supplementation
Intervention Type
Behavioral
Intervention Name(s)
Physical training alone
Intervention Description
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
Intervention Name(s)
physical training + protein intake
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in body weight from baseline
Description
body weight using a classical scale at different time : baseline, after the 12-week intervention and after 6 weeks of follow-up .
Time Frame
day 1, day 90, day 145
Title
Change in fat mass composition
Description
fat mass will be assessed using DXA
Time Frame
day 1, day 90, day 145
Title
Change in fat free mass composition
Description
fat free mass will be assessed using DXA
Time Frame
day 1, day 90, day 145
Secondary Outcome Measure Information:
Title
Change in bone structure
Description
the bone structure will be assessed thanks to DXA and pQCT
Time Frame
day 1, day 90, day 145
Title
Change in muscle strength
Description
muscle strength assessed thanks to isometric contraction using Biodex.
Time Frame
day 1, day 90, day 145
Title
Change in muscle structure
Description
muscle structure assessed thanks to muscle echography
Time Frame
day 1, day 90, day 145
Title
Change in aerobic capacities .
Description
aerobic capacities assessed using indirect calorimetry during a graded cycling exercise
Time Frame
day 1, day 90, day 145
Title
Change in resting metabolic rate
Description
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.
Time Frame
day 1, day 90, day 145
Title
Change in Insulin
Description
Insulin will be evaluated in blood sample
Time Frame
day 1, day 90, day 145
Title
Change in glycaemia, .
Description
glycaemia will be evaluated in blood sample
Time Frame
day 1, day 90, day 145
Title
Change in triglycerides
Description
triglycerides will be evaluated in blood sample
Time Frame
day 1, day 90, day 145
Title
Change in cholesterol
Description
cholesterol will be evaluated in blood sample
Time Frame
day 1, day 90, day 145
Title
Change in leptin
Description
leptin will be evaluated in blood sample
Time Frame
day 1, day 90, day 145
Title
Change in ghrelin
Description
ghrelin will be evaluated in blood sample
Time Frame
day 1, day 90, day 145
Title
Change in adiponectin
Description
adiponectin will be evaluated in blood sample
Time Frame
day 1, day 90, day 145
Title
Change in thyroid hormones
Description
thyroid hormones will be evaluated in blood sample
Time Frame
day 1, day 90, day 145
Title
Change in LipoxMax
Description
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.
Time Frame
day 1, day 90, day 145
Title
Change in Energy intake
Description
Energy Intake will be assessed using a Three-day dietary report (self-reported)
Time Frame
day 1, day 90, day 145
Title
Change in physical activity level measured with an accelerometer
Description
The time spent at low-moderate and vigorous physical activity will be assessed using a 7-day accelerometry record
Time Frame
day 1, day 90, day 145
Title
Change in sleep metabolism assessed with the dreem technology captors
Description
sleep metabolism assessed during a complete night, using the Dreem technology captors that consists in a simple band around the head during the night.
Time Frame
day 1, day 90, day 145

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine DUCLOS
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Martine DUCLOS

12. IPD Sharing Statement

Learn more about this trial

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

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