Athletes Clinical Trial
— WAVEOfficial title:
Metabolic, Functional and Nutritional Responses to Weight Cycling in Athletes: The WAVE Study
Verified date | March 2024 |
Source | University Hospital, Clermont-Ferrand |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | December 12, 2023 |
Est. primary completion date | December 12, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Chu Clermont Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | Laboratoire AME2P, Université de Fribourg, Department of Endocrinology, Metabolism and Cardiovascular System, University of Leeds, Appetite Control and Energy Balance Research |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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).) | Day 1 , Day 60 , Day 90 | |
Secondary | 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).) |
Day 1 , Day 60 , Day 90 | |
Secondary | 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).) |
Day 1 , Day 60 , Day 90 | |
Secondary | 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).) | Day 1 , Day 60 , Day 90 | |
Secondary | Basal Metabolic rate | the resting energy expenditure will be assessed at rest during 30 minutes using indirect calorimetry (COSMED Fitmate Pro) | Day 1 , Day 60 , Day 90 | |
Secondary | Cortisol | Cortisol concentrations will be assessed in the fasting state using salivary sample. | Day 1 , Day 60 , Day 90 | |
Secondary | Measure of insulin mlUI/L | Insulin concentrations will be assessed in the fasting state using blood sample. | Day 1 , Day 60 , Day 90 | |
Secondary | Measure of glucose g/L | Glucose concentrations will be assessed in the fasting state using blood sample. | Day 1 , Day 60 , Day 90 | |
Secondary | Measure of triglycerides g/L | triglycerides concentrations will be assessed in the fasting state using blood sample. | Day 1 , Day 60 , Day 90 | |
Secondary | Measure of LDL g/L | LDL concentrations will be assessed in the fasting state using blood sample. | Day 1 , Day 60 , Day 90 | |
Secondary | Measure of HDL g/L | HDL concentrations will be assessed in the fasting state using blood sample. | Day 1 , Day 60 , Day 90 | |
Secondary | Measure of cholesterol g/L | cholesterol concentrations will be assessed in the fasting state using blood sample. | Day 1 , Day 60 , Day 90 | |
Secondary | 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. | Day 1 , Day 60 , Day 90 | |
Secondary | Muscle strength | 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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