NCT04107545

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 3, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2023

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

2.6 years

First QC Date

September 20, 2019

Last Update Submit

March 7, 2024

Conditions

Keywords

weight cyclingsportappetiteenergy metabolism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Body fat mass

    Day 1 , Day 60 , Day 90

  • Body fat free mass

    Day 1 , Day 60 , Day 90

  • Food reward

    Day 1 , Day 60 , Day 90

  • Basal Metabolic rate

    Day 1 , Day 60 , Day 90

  • Cortisol

    Day 1 , Day 60 , Day 90

  • +8 more secondary outcomes

Study Arms (1)

athletes

EXPERIMENTAL

48 elite athletes, 24 men and 24 women, experiencing regular weight cycling.

Behavioral: athletes

Interventions

athletesBEHAVIORAL

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

athletes

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • Bagot 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.

MeSH Terms

Conditions

Weight Cycling

Interventions

Cardiomegaly, Exercise-Induced

Condition Hierarchy (Ancestors)

Weight GainBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsWeight Loss

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Martine Duclos

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2019

First Posted

September 27, 2019

Study Start

May 3, 2021

Primary Completion

December 12, 2023

Study Completion

December 12, 2023

Last Updated

March 8, 2024

Record last verified: 2024-03

Locations