- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04107545
Metabolic, Functional and Nutritional Responses to Weight Cycling in Athletes: The WAVE Study (WAVE)
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
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Clermont-Ferrand, France, 63003
- CHU Clermont Ferrand
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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Control of body temperature using the bodyCap temperature monitor that records body temperature for up to 48h (three times)
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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
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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
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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
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Insulin concentrations will be assessed in the fasting state using blood sample.
|
Day 1 , Day 60 , Day 90
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Measure of glucose g/L
Time Frame: Day 1 , Day 60 , Day 90
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Glucose concentrations will be assessed in the fasting state using blood sample.
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Day 1 , Day 60 , Day 90
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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
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Measure of LDL g/L
Time Frame: Day 1 , Day 60 , Day 90
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LDL concentrations will be assessed in the fasting state using blood sample.
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Day 1 , Day 60 , Day 90
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Measure of HDL g/L
Time Frame: Day 1 , Day 60 , Day 90
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HDL concentrations will be assessed in the fasting state using blood sample.
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Day 1 , Day 60 , Day 90
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Measure of cholesterol g/L
Time Frame: Day 1 , Day 60 , Day 90
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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
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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
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Martine Duclos, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
Studies a U.S. FDA-regulated device product
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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