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

Adaptations of Exercise Energy Metabolism in Response to Simulated Weight Loss Versus Effective Weight Loss Induced by Diet in Healthy Normal Weight

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Body Weight; Weight Loss; Diet Habit; Healthy Nutrition
• Intervention / Treatment: Behavioral: Dietary weight loss intervention

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aura
    • Clermont-Ferrand, Aura, France, 63000
      • Recruiting
      • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental group

Behavioral: Dietary weight loss intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory quotient during exercise	Respiratory quotient measured by indirect calorimetry during the low intensity exercise.	Week 1
Respiratory quotient during exercise	Respiratory quotient measured by indirect calorimetry during the low intensity exercise.	Week 2
Respiratory quotient during exercise	Respiratory quotient measured by indirect calorimetry during the low intensity exercise.	Week 3
Respiratory quotient during exercise	Respiratory quotient measured by indirect calorimetry during the low intensity exercise.	Week 4
Respiratory quotient during exercise	Respiratory quotient measured by indirect calorimetry during the low intensity exercise.	Week 8
Respiratory quotient during exercise	Respiratory quotient measured by indirect calorimetry during the low intensity exercise.	Week 12

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2022
• Primary Completion (Anticipated): September 26, 2025
• Study Completion (Anticipated): September 26, 2025

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: RBHP 2022 DUCLOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No