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

NCT05370222 | Unknown

• 1 other identifier: RBHP 2022 DUCLOS
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Weight Loss; Body Weight; Diet Habit; Healthy Nutrition

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Experimental group

EXPERIMENTAL

Behavioral: Dietary weight loss intervention

Interventions

Dietary weight loss intervention BEHAVIORAL

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,
• 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,
• Regular consumption of tobacco or alcohol,
• Voluntary weight loss in the last 6 months,

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, AURA, 63000, France

RECRUITING

MeSH Terms

Conditions

Weight Loss; Body Weight; Feeding Behavior

Condition Hierarchy (Ancestors)

Body Weight Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Central Study Contacts

Lise Laclautre

CONTACT

04 73 75 11 95; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 11, 2022
• Study Start: May 26, 2022
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)