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Adaptations of Exercise Energy Metabolism in Response to Weight Loss in Healthy Normal Weight People (NUTRILEX)

Primary Purpose

Healthy, Weight Loss, Body Weight

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dietary weight loss intervention
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Body mass index (BMI) between 18.5 and 24.9 kg/m²,
  • Subjects abled to understand the information note and abled to sign the consent form,
  • Subjects with stable body weight (variation < 3% of body weight) until at least 6 months,
  • Subjects subjected to a social security plan.

Non-Criteria:

  • Have achieved a minimal BMI < 18.5 or maximal BMI ≥ 25 kg/m² in adult life,
  • Subjects with high levels of physical activity (> 5 h of exercise per week),
  • Presence of comorbidities or medical conditions that may interfere with study data,
  • Subjects undergoing energy restriction or physical activity weight loss program at the time of inclusion or within the past 6 months,
  • Taking medication that may interfere with study results,
  • Surgery within the last 3 months,
  • Person under guardianship, curatorship, or safeguard of justice; or not subject to a social security plan,
  • Pregnant or breastfeeding women,
  • Refusal to sign the consent form,
  • Person in a period of exclusion from another study,
  • Regular consumption of tobacco or alcohol,
  • Voluntary weight loss in the last 6 months,
  • Present or past eating disorders.

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

Outcomes

Primary Outcome Measures

Respiratory quotient during exercise
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Respiratory quotient during exercise
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Respiratory quotient during exercise
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Respiratory quotient during exercise
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Respiratory quotient during exercise
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Respiratory quotient during exercise
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.

Secondary Outcome Measures

Full Information

First Posted
May 2, 2022
Last Updated
May 31, 2022
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT05370222
Brief Title
Adaptations of Exercise Energy Metabolism in Response to Weight Loss in Healthy Normal Weight People
Acronym
NUTRILEX
Official Title
Adaptations of Exercise Energy Metabolism in Response to Simulated Weight Loss Versus Effective Weight Loss Induced by Diet in Healthy Normal Weight
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
September 26, 2025 (Anticipated)
Study Completion Date
September 26, 2025 (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
More and more normal weight people are dieting in the general population. The NUTRILEX study aims to better understand the physiological adaptations in response to weight loss in healthy normal weight individuals. After an inclusion visit to verify the eligibility criteria of the subjects, they will complete a "T0" control session. The subjects will then have to complete two phases. The first transversal phase consists of 4 randomized sessions with lunch ad libitum after a physical exercise: i) a control session (no exercise, CON); ii) an exercise session at initial body weight (BWT0); iii) an exercise session with a simulated weight loss of 3% performed on an anti-gravity treadmill (BW-3%) and; iv) an exercise session with a simulated weight loss of 6% performed on an anti-gravity treadmill (BW-6%). During the second longitudinal phase, the participants will perform a dietary rebalancing and a slight caloric restriction (dietary intervention) in order to induce a weight loss of 6% of their initial body weight. Subjects will then perform an exercise session after losing 3% (T1) and then 6% (T2) of their initial body weight.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Weight Loss, Body Weight, Diet Habit, Healthy Nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Dietary weight loss intervention
Intervention Description
Based on an energy assessment from the data collected at T0 (energy intake, physical activity level, and resting metabolism), individualized nutritional advice will be given during an interview in order to propose a dietary rebalancing and a light caloric restriction. Caloric restriction will be generated to decrease body weight by ≈ 0.5 to 1 kg per week, as advised in several publications. As for the dietary rebalancing, it will concern in particular the distribution of macronutrients and their nature (glycemic index, nature of lipids), the fibers intake, or the reduction of consumption of refined and/or energy-dense foods based on the ANSES Recommended Dietary Allowances and on the food consumption guidelines of the National Nutrition and Health Program.
Primary Outcome Measure Information:
Title
Respiratory quotient during exercise
Description
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Time Frame
Week 1
Title
Respiratory quotient during exercise
Description
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Time Frame
Week 2
Title
Respiratory quotient during exercise
Description
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Time Frame
Week 3
Title
Respiratory quotient during exercise
Description
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Time Frame
Week 4
Title
Respiratory quotient during exercise
Description
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Time Frame
Week 8
Title
Respiratory quotient during exercise
Description
Respiratory quotient measured by indirect calorimetry during the low intensity exercise.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body mass index (BMI) between 18.5 and 24.9 kg/m², Subjects abled to understand the information note and abled to sign the consent form, Subjects with stable body weight (variation < 3% of body weight) until at least 6 months, Subjects subjected to a social security plan. Non-Criteria: Have achieved a minimal BMI < 18.5 or maximal BMI ≥ 25 kg/m² in adult life, Subjects with high levels of physical activity (> 5 h of exercise per week), Presence of comorbidities or medical conditions that may interfere with study data, Subjects undergoing energy restriction or physical activity weight loss program at the time of inclusion or within the past 6 months, Taking medication that may interfere with study results, Surgery within the last 3 months, Person under guardianship, curatorship, or safeguard of justice; or not subject to a social security plan, Pregnant or breastfeeding women, Refusal to sign the consent form, Person in a period of exclusion from another study, Regular consumption of tobacco or alcohol, Voluntary weight loss in the last 6 months, Present or past eating disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
04 73 75 11 95
Email
promo_interne_drci@chu-clermontferrand.fr
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
State/Province
Aura
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Phone
04 73 75 11 95
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Martine DUCLOS

12. IPD Sharing Statement

Plan to Share IPD
No

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Adaptations of Exercise Energy Metabolism in Response to Weight Loss in Healthy Normal Weight People

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