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

March 7, 2024 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Clermont-Ferrand, France, 63003
        • CHU Clermont Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: athletes
48 elite athletes, 24 men and 24 women, experiencing regular weight cycling.
Control of body temperature using the bodyCap temperature monitor that records body temperature for up to 48h (three times)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).)
Day 1 , Day 60 , Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).)

Day 1 , Day 60 , Day 90
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).)

Day 1 , Day 60 , Day 90
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).)
Day 1 , Day 60 , Day 90
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)
Day 1 , Day 60 , Day 90
Cortisol
Time Frame: Day 1 , Day 60 , Day 90
Cortisol concentrations will be assessed in the fasting state using salivary sample.
Day 1 , Day 60 , Day 90
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.
Day 1 , Day 60 , Day 90
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.
Day 1 , Day 60 , Day 90
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.
Day 1 , Day 60 , Day 90
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.
Day 1 , Day 60 , Day 90
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.
Day 1 , Day 60 , Day 90
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.
Day 1 , Day 60 , Day 90
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.
Day 1 , Day 60 , Day 90
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.
Day 1 , Day 60 , Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2021

Primary Completion (Actual)

December 12, 2023

Study Completion (Actual)

December 12, 2023

Study Registration Dates

First Submitted

September 20, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • RBHP 2019 DUCLOS
  • 2019-A00699-48 (Other Identifier: 2019-A00699-48)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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