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 +)

April 28, 2021 updated by: University Hospital, Clermont-Ferrand
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in body weight from baseline
Time Frame: day 1, day 90, day 145
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
Time Frame: day 1, day 90, day 145
fat mass will be assessed using DXA
day 1, day 90, day 145
Change in fat free mass composition
Time Frame: day 1, day 90, day 145
fat free mass will be assessed using DXA
day 1, day 90, day 145

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in bone structure
Time Frame: day 1, day 90, day 145
the bone structure will be assessed thanks to DXA and pQCT
day 1, day 90, day 145
Change in muscle strength
Time Frame: day 1, day 90, day 145
muscle strength assessed thanks to isometric contraction using Biodex.
day 1, day 90, day 145
Change in muscle structure
Time Frame: day 1, day 90, day 145
muscle structure assessed thanks to muscle echography
day 1, day 90, day 145
Change in aerobic capacities .
Time Frame: day 1, day 90, day 145
aerobic capacities assessed using indirect calorimetry during a graded cycling exercise
day 1, day 90, day 145
Change in resting metabolic rate
Time Frame: day 1, day 90, day 145
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
Time Frame: day 1, day 90, day 145
Insulin will be evaluated in blood sample
day 1, day 90, day 145
Change in glycaemia, .
Time Frame: day 1, day 90, day 145
glycaemia will be evaluated in blood sample
day 1, day 90, day 145
Change in triglycerides
Time Frame: day 1, day 90, day 145
triglycerides will be evaluated in blood sample
day 1, day 90, day 145
Change in cholesterol
Time Frame: day 1, day 90, day 145
cholesterol will be evaluated in blood sample
day 1, day 90, day 145
Change in leptin
Time Frame: day 1, day 90, day 145
leptin will be evaluated in blood sample
day 1, day 90, day 145
Change in ghrelin
Time Frame: day 1, day 90, day 145
ghrelin will be evaluated in blood sample
day 1, day 90, day 145
Change in adiponectin
Time Frame: day 1, day 90, day 145
adiponectin will be evaluated in blood sample
day 1, day 90, day 145
Change in thyroid hormones
Time Frame: day 1, day 90, day 145
thyroid hormones will be evaluated in blood sample
day 1, day 90, day 145
Change in LipoxMax
Time Frame: day 1, day 90, day 145
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
Time Frame: day 1, day 90, day 145
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
Time Frame: day 1, day 90, day 145
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
Time Frame: day 1, day 90, day 145
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 11, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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