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Completed

NCT Number: NCT04107545

Metabolic, Functional and Nutritional Responses to Weight Cycling in Athletes: The WAVE Study

Many elite athletes are submitted to frequent rapid weight loss periods to meet their competition weight category and then experience weight cycling (lowing and gaining weight regularly). This weight cycling induce severe temporary energetic and metabolic changes and when repeated over time can lead to permanent metabolic adaptations that might favor metabolic disorders, body weight gain and body composition changes (favoring fat mass). The exact effects of this weight cycling are not clear yet, especially in terms of metabolic, energetics, nutritional functional and psychological impacts. Better understand these adaptations and their variations during weight loss and weight gain in regular weight cycler is of main importance to prevent these athletes for future health issues.

The aim of the present project if to assess these metabolic, functional, energetic and nutritional adaptations during weight loss, weight stable and weight gain periods in athletes experiencing regular weight cycling.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

About this study

After an inclusion visit to ensure the eligibility of athletes to complete the entire study, each subject will perform 3 experimental sessions of 2 visits each : i) two visits during a period of maintenance of body weight (CON); ii) two visits during weight loss (WL); iii) two visits during a weight regain (WG). The order of the periods (maintenance, loss or weight gain) will depend on the dynamics of the weight variations of each athlete (endurance sport and weight class) during the season and will therefore be individualized.

All experiments will be conducted in the same way for the CON, WL or WG session.

Upon arrival, each subject will perform a resting metabolism with continuous measurement of heart rate variability (≈ 30 min). Then, from 8:30, blood and saliva samples will be taken (≈ 10 min). Then (≈ 8:45), they will perform anthropometric and body composition measurements (waist circumference, hip circumference, bioimpedance, DXA) (≈ 30 min). Following these measurements (≈ 9:15), the subjects will eat a standardized breakfast and the report to food will be evaluated thanks to the Leeds Foods Preference Questionnaire before and after the meal. They will then be asked (≈ 10h) to complete the Profile of Mood State Questionnaire to measure the athlete's psychological state. Participants will then perform a measurement of muscle function (≈ 10:30).

During the second visit, carried out between 1 and 5 days after the first visit, the maximum aerobic capacity of the athletes will be evaluated by mid-morning stress test.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects aged 18 to 35 (inclusive),
  • exercising at least 4 sessions of endurance or weight-based sporting activities per week for a performance objective,
  • having variations of at least 5% of their weight body during the last 3 sporting seasons (a sporting season corresponds to a year during which alternates the periods of training, recovery and participation in official competitions).
  • Subject capable of providing informed consent to participate
  • Subject with a social security insurance.

Exclusion criteria

  • Medical or surgical history deemed by the investigator to be incompatible with the study.
  • Presence of chronic pathology.
  • Disorders of eating behavior.
  • Subjects born very prematurely defined as a pregnancy inferior to 28 weeks.
  • Subjects having used a treatment for a small stature (eg growth hormone).
  • For women: irregular menstruation (changes in menstrual cycles ≥ 6 days).
  • Sports subjects with a stable weight during the last three sporting seasons (weight variation <5%).
  • Take medication that can change body temperature.
  • Pregnant or lactating women.
  • Subjects with gastrointestinal complications and / or contraindications to ingestion of the capsule (eg diverticulosis, inflammatory bowel disease, gastrointestinal surgery ...).
  • Subjects needing MRI during ingestion of the capsule or having a pacemaker or other implanted electro-medical device.
  • Person under guardianship or not subject to a social security scheme.
  • Refusal to sign the information and consent leaflet.
  • Refusal of participation

Treatment and study plan

athletes

Behavioral

Control of body temperature using the bodyCap temperature monitor that records body temperature for up to 48h (three times)

Primary outcomes

  1. Change in Body temperature

    Time frame: Day 1 , Day 60 , Day 90

    body temperature will be assessed using the bodyCap temperature monitor that records body temperature for up to 48h. this will be assessed for 24h on the three different phase (i) period of maintenance of body weight (CON); ii) two visits during weight loss (WL); iii) two visits during a weight regain (WG).)

Secondary outcomes

  1. Body fat mass

    Time frame: Day 1 , Day 60 , Day 90

    the percentage of body fat will be assessed using X-ray absorptiometry (DXA)

    . This will be assessed on the three different phase (i) period of maintenance of body weight (CON); ii) two visits during weight loss (WL); iii) two visits during a weight regain (WG).)

  2. Body fat free mass

    Time frame: Day 1 , Day 60 , Day 90

    the percentage of body fat free will be assessed using X-ray absorptiometry (DXA)

    . This will be assessed on the three different phase (i) period of maintenance of body weight (CON); ii) two visits during weight loss (WL); iii) two visits during a weight regain (WG).)

  3. Food reward

    Time frame: Day 1 , Day 60 , Day 90

    The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ) (Finlayson, King et al. 2008). This will be assessed on the three different phase (i) period of maintenance of body weight (CON); ii) two visits during weight loss (WL); iii) two visits during a weight regain (WG).)

  4. Basal Metabolic rate

    Time frame: Day 1 , Day 60 , Day 90

    the resting energy expenditure will be assessed at rest during 30 minutes using indirect calorimetry (COSMED Fitmate Pro)

  5. Cortisol

    Time frame: Day 1 , Day 60 , Day 90

    Cortisol concentrations will be assessed in the fasting state using salivary sample.

  6. Measure of insulin mlUI/L

    Time frame: Day 1 , Day 60 , Day 90

    Insulin concentrations will be assessed in the fasting state using blood sample.

  7. Measure of glucose g/L

    Time frame: Day 1 , Day 60 , Day 90

    Glucose concentrations will be assessed in the fasting state using blood sample.

  8. Measure of triglycerides g/L

    Time frame: Day 1 , Day 60 , Day 90

    triglycerides concentrations will be assessed in the fasting state using blood sample.

  9. Measure of LDL g/L

    Time frame: Day 1 , Day 60 , Day 90

    LDL concentrations will be assessed in the fasting state using blood sample.

  10. Measure of HDL g/L

    Time frame: Day 1 , Day 60 , Day 90

    HDL concentrations will be assessed in the fasting state using blood sample.

  11. Measure of cholesterol g/L

    Time frame: Day 1 , Day 60 , Day 90

    cholesterol concentrations will be assessed in the fasting state using blood sample.

  12. Psychological profile

    Time frame: Day 1 , Day 60 , Day 90

    The psychological profile of the athletes will be assessed using the Profile of Mood state questionnaire that is a self-reported short pain and paper questionnaire.

  13. Muscle strength

    Time frame: Day 1 , Day 60 , Day 90

    the muscle strength (in watt) will be assessed during a forced isometric contraction on a biodex.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Laboratoire AME2P
  • University of Leeds, Appetite Control and Energy Balance Research
  • Université de Fribourg, Department of Endocrinology, Metabolism and Cardiovascular System

Registry information

Acronym: WAVE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 27, 2019
Registry last updated
Mar 8, 2024

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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