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Completed

NCT Number: NCT05370222

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

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.

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Key information

Conditions

Healthy Behavior Behavior, Animal Body Weight Body Weight Changes Diet Habit Feeding Behavior Healthy Nutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, AURA, 63000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Respiratory quotient during exercise

    Time frame: Week 1

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

  2. Respiratory quotient during exercise

    Time frame: Week 2

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

  3. Respiratory quotient during exercise

    Time frame: Week 3

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

  4. Respiratory quotient during exercise

    Time frame: Week 4

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

  5. Respiratory quotient during exercise

    Time frame: Week 8

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

  6. Respiratory quotient during exercise

    Time frame: Week 12

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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: NUTRILEX

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 11, 2022
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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