AthletesWAVENCT04107545
Metabolic, Functional and Nutritional Responses to Weight Cycling in Athletes: The WAVE Study
A study testing athletes in people with Athletes, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletes
- What is being tested?
- athletes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2021to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Athletes
- Being tested
- athletes
- Keywords
- weight cycling, sport, appetite, energy metabolism
- Medical subject headings
- Weight Cycling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
athletesBehavioural
Control of body temperature using the bodyCap temperature monitor that records body temperature for up to 48h (three times)
| Study group | Role | What they receive |
|---|---|---|
| athletes | Experimental | 48 elite athletes, 24 men and 24 women, experiencing regular weight cycling. Receives: Behavioral: athletes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body temperature
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).)
Measured: Day 1 , Day 60 , Day 90
Secondary outcomes (13)
Body fat mass
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).)
Measured: Day 1 , Day 60 , Day 90
Body fat free mass
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).)
Measured: Day 1 , Day 60 , Day 90
Food reward
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).)
Measured: Day 1 , Day 60 , Day 90
Basal Metabolic rate
the resting energy expenditure will be assessed at rest during 30 minutes using indirect calorimetry (COSMED Fitmate Pro)
Measured: Day 1 , Day 60 , Day 90
Cortisol
Cortisol concentrations will be assessed in the fasting state using salivary sample.
Measured: Day 1 , Day 60 , Day 90
Measure of insulin mlUI/L
Insulin concentrations will be assessed in the fasting state using blood sample.
Measured: Day 1 , Day 60 , Day 90
Measure of glucose g/L
Glucose concentrations will be assessed in the fasting state using blood sample.
Measured: Day 1 , Day 60 , Day 90
Measure of triglycerides g/L
triglycerides concentrations will be assessed in the fasting state using blood sample.
Measured: Day 1 , Day 60 , Day 90
Measure of LDL g/L
LDL concentrations will be assessed in the fasting state using blood sample.
Measured: Day 1 , Day 60 , Day 90
Measure of HDL g/L
HDL concentrations will be assessed in the fasting state using blood sample.
Measured: Day 1 , Day 60 , Day 90
Measure of cholesterol g/L
cholesterol concentrations will be assessed in the fasting state using blood sample.
Measured: Day 1 , Day 60 , Day 90
Psychological profile
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.
Measured: Day 1 , Day 60 , Day 90
Muscle strength
the muscle strength (in watt) will be assessed during a forced isometric contraction on a biodex.
Measured: Day 1 , Day 60 , Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start3 May 2021
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AthletesStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques, Université de Fribourg, Department of Endocrinology, Metabolism and Cardiovascular System, University of Leeds, Appetite Control and Energy Balance Research
- Responsible party
- Sponsor
- Investigators
- Martine Duclos, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107545
- Sponsor's protocol ID
- RBHP 2019 DUCLOS
- Other IDs
- 2019-A00699-48
- Acronym
- WAVE
- Status last verified
- Jul 2026
- First submitted
- 20 Sep 2019
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bagot S, Ramos I, Hackney AC, Finlayson G, Fournier E, Boirie Y, Duclos M, Isacco L, Thivel D. Appetite-Control and Eating-Behavior Traits Might Not Be Impacted by a Single Weight-Cycling Episode in Weight-Cycling Athletes: Results of the Wave Study. Int J Sports Physiol Perform. 2025 Jan 27;20(3):372-384. doi: 10.1123/ijspp.2024-0298. Print 2025 Mar 1.
PubMed 39870075Bagot S, Ramos I, Miles-Chan J, Dulloo A, Hackney A, Boirie Y, Duclos M, Thivel D, Isacco L. The type of sport, but not sex, impacts body composition and metabolic response to a complete weight loss-weight regain episode in weight cycling athletes: results from the WAVE study. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-13. doi: 10.1139/apnm-2024-0376.
PubMed 39919268
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic, Functional and Nutritional Responses to Weight Cycling in Athletes: The WAVE Study
- ClinicalTrials.gov ID
- NCT04107545
- Acronym / sponsor ID
- WAVE / RBHP 2019 DUCLOS
- Conditions
- Athletes
- Keywords
- weight cycling, sport, appetite, energy metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques, Université de Fribourg, Department of Endocrinology, Metabolism and Cardiovascular System, University of Leeds, Appetite Control and Energy Balance Research
- Study start
- 3 May 2021 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| athletes | Experimental | Behavioral: athletes48 elite athletes, 24 men and 24 women, experiencing regular weight cycling. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| athletesControl of body temperature using the bodyCap temperature monitor that records body temperature for up to 48h (three times) | Behavioural | athletes |
Primary outcome
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).)
13 secondary outcomes
Body fat mass
Time frame: Day 1 , Day 60 , Day 90
Body fat free mass
Time frame: Day 1 , Day 60 , Day 90
Food reward
Time frame: Day 1 , Day 60 , Day 90
Basal Metabolic rate
Time frame: Day 1 , Day 60 , Day 90
Cortisol
Time frame: Day 1 , Day 60 , Day 90
Measure of insulin mlUI/L
Time frame: Day 1 , Day 60 , Day 90
Measure of glucose g/L
Time frame: Day 1 , Day 60 , Day 90
Measure of triglycerides g/L
Time frame: Day 1 , Day 60 , Day 90
Measure of LDL g/L
Time frame: Day 1 , Day 60 , Day 90
Measure of HDL g/L
Time frame: Day 1 , Day 60 , Day 90
Measure of cholesterol g/L
Time frame: Day 1 , Day 60 , Day 90
Psychological profile
Time frame: Day 1 , Day 60 , Day 90
Muscle strength
Time frame: Day 1 , Day 60 , Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Results publication: PubMed 39870075Bagot S, Ramos I, Hackney AC, Finlayson G, Fournier E, Boirie Y, Duclos M, Isacco L, Thivel D. Appetite-Control and Eating-Behavior Traits Might Not Be Impacted by a Single Weight-Cycling Episode in Weight-Cycling Athletes: Results of the Wave Study. Int J Sports Physiol Perform. 2025 Jan 27;20(3):372-384. doi: 10.1123/ijspp.2024-0298. Print 2025 Mar 1.
- Derived from this study: PubMed 39919268Bagot S, Ramos I, Miles-Chan J, Dulloo A, Hackney A, Boirie Y, Duclos M, Thivel D, Isacco L. The type of sport, but not sex, impacts body composition and metabolic response to a complete weight loss-weight regain episode in weight cycling athletes: results from the WAVE study. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-13. doi: 10.1139/apnm-2024-0376.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Duclos principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing athletes in people with Athletes, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body temperature (time frame: Day 1 , Day 60 , Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04107545, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.