Healthy Normal Weight WomenNUTRILEAN +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
A study testing Physical training alone and physical training + protein intake in people with Healthy Normal Weight Women and Constitutionally Lean Women, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Normal Weight Women, Constitutionally Lean Women
- What is being tested?
- Physical training alone and physical training + protein intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2021to 11 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Chu Clermont Ferrand
Clermont-Ferrand, 63003
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Martine DUCLOS
About this study
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.
Read the 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
- Being tested
- Physical training alone, physical training + protein intake
- Keywords
- energy metabolism, body composition, physical training, constitutional leanness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical training aloneBehavioural
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.
physical training + protein intakeBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | Active comparator | the normal weight women will receive the 12-week physical activity intervention and serve as a control group. Receives: Behavioral: Physical training alone |
| constitutionally lean women - Physical training only | Experimental | women will receive the 12-week physical activity intervention Receives: Behavioral: Physical training alone |
| constitutionally lean women - Physical training + proteins | Experimental | women will receive the 12-week physical activity intervention in addition to a protein supplementation Receives: Behavioral: physical training + protein intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: day 1, day 90, day 145
Change in fat mass composition
fat mass will be assessed using DXA
Measured: day 1, day 90, day 145
Change in fat free mass composition
fat free mass will be assessed using DXA
Measured: day 1, day 90, day 145
Secondary outcomes (17)
Change in bone structure
the bone structure will be assessed thanks to DXA and pQCT
Measured: day 1, day 90, day 145
Change in muscle strength
muscle strength assessed thanks to isometric contraction using Biodex.
Measured: day 1, day 90, day 145
Change in muscle structure
muscle structure assessed thanks to muscle echography
Measured: day 1, day 90, day 145
Change in aerobic capacities .
aerobic capacities assessed using indirect calorimetry during a graded cycling exercise
Measured: day 1, day 90, day 145
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.
Measured: day 1, day 90, day 145
Change in Insulin
Insulin will be evaluated in blood sample
Measured: day 1, day 90, day 145
Change in glycaemia, .
glycaemia will be evaluated in blood sample
Measured: day 1, day 90, day 145
Change in triglycerides
triglycerides will be evaluated in blood sample
Measured: day 1, day 90, day 145
Change in cholesterol
cholesterol will be evaluated in blood sample
Measured: day 1, day 90, day 145
Change in leptin
leptin will be evaluated in blood sample
Measured: day 1, day 90, day 145
Change in ghrelin
ghrelin will be evaluated in blood sample
Measured: day 1, day 90, day 145
Change in adiponectin
adiponectin will be evaluated in blood sample
Measured: day 1, day 90, day 145
Change in thyroid hormones
thyroid hormones will be evaluated in blood sample
Measured: day 1, day 90, day 145
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.
Measured: day 1, day 90, day 145
Change in Energy intake
Energy Intake will be assessed using a Three-day dietary report (self-reported)
Measured: day 1, day 90, day 145
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
Measured: day 1, day 90, day 145
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.
Measured: day 1, day 90, day 145
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 May 2021 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion11 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Normal Weight WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine DUCLOS, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749706
- Sponsor's protocol ID
- RBHP 2020 DUCLOS
- Other IDs
- 2020-A02565-34
- Acronym
- NUTRILEAN +
- Status last verified
- Apr 2021
- First submitted
- 4 Feb 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04749706
- Acronym / sponsor ID
- NUTRILEAN + / RBHP 2020 DUCLOS
- Keywords
- energy metabolism, body composition, physical training, constitutional leanness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 11 Dec 2023 (estimated)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal weight | Active comparator | Behavioral: Physical training alonethe normal weight women will receive the 12-week physical activity intervention and serve as a control group. |
| constitutionally lean women - Physical training only | Experimental | Behavioral: Physical training alonewomen will receive the 12-week physical activity intervention |
| constitutionally lean women - Physical training + proteins | Experimental | Behavioral: physical training + protein intakewomen will receive the 12-week physical activity intervention in addition to a protein supplementation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical training aloneThe 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. | Behavioural | Normal weight, constitutionally lean women - Physical training only |
| physical training + protein intakeThe 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 | Behavioural | constitutionally lean women - Physical training + proteins |
Primary outcome
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 .
Change in fat mass composition
Time frame: day 1, day 90, day 145
fat mass will be assessed using DXA
Change in fat free mass composition
Time frame: day 1, day 90, day 145
fat free mass will be assessed using DXA
17 secondary outcomes
Change in bone structure
Time frame: day 1, day 90, day 145
Change in muscle strength
Time frame: day 1, day 90, day 145
Change in muscle structure
Time frame: day 1, day 90, day 145
Change in aerobic capacities .
Time frame: day 1, day 90, day 145
Change in resting metabolic rate
Time frame: day 1, day 90, day 145
Change in Insulin
Time frame: day 1, day 90, day 145
Change in glycaemia, .
Time frame: day 1, day 90, day 145
Change in triglycerides
Time frame: day 1, day 90, day 145
Change in cholesterol
Time frame: day 1, day 90, day 145
Change in leptin
Time frame: day 1, day 90, day 145
Change in ghrelin
Time frame: day 1, day 90, day 145
Change in adiponectin
Time frame: day 1, day 90, day 145
Change in thyroid hormones
Time frame: day 1, day 90, day 145
Change in LipoxMax
Time frame: day 1, day 90, day 145
Change in Energy intake
Time frame: day 1, day 90, day 145
Change in physical activity level measured with an accelerometer
Time frame: day 1, day 90, day 145
Change in sleep metabolism assessed with the dreem technology captors
Time frame: day 1, day 90, day 145
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine DUCLOS principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training alone and physical training + protein intake in people with Healthy Normal Weight Women and Constitutionally Lean Women, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight from baseline (time frame: day 1, day 90, day 145). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.