Clinical trial NCT04392752: Fitness Study 2020
Official title: Effects of the Fitness Competition Period on Body Composition, Neuromuscular Performance, Physiological and Psychological Factors in Fitness Athletes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Reduction
Diet; Deficiency
Lead sponsor: University of Jyvaskyla
Sponsor class: OTHER
Collaborators: name: Finnish Institute for Health and Welfare
First posted: 2020-05-19
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study includes four laboratory testing sessions over the 50-week period. Testing sessions will be performed over one week. Time points include testing before the diet or the control period start (PRE), one week before the competition (MID), after the competition (COMP) and after a recovery period (POST), during which the participants are advised to continue their normal training regimen, but to stop competition dieting. Participants will spend three hours in the laboratory between 0700-1300. The control group will be advised to maintain their normal physical activity diet throughout the study. The participants will be given identification numbers and the research group is blinded so that they do not know which group participants belong to. All measurements will be conducted at the same time (always within max ±1 hour) due to the importance of standardizing the time of the day of measurements.
Primary purpose: BASIC_SCIENCE

Brief summary: The experimental participant group (n=15+15) includes male and female fitness athletes during their \~25 week competition preparation in fall 2019 for the Finnish national championships. Participants must have at least two years of goal-oriented gym training and their health status will be determined before measurements via an online pre-study questionnaire. The control group (n=15+15) will maintain their normal training and diet without competing during the study period. Otherwise, the control group is matched with the athletic group based on age, height, weight and training experience. Participants selected for the study will complete an additional questionnaire to be reviewed by the study physician to confirm that participants meet the health status inclusion criteria. This study includes four laboratory testing sessions over the 50-week period. Time points include testing before the diet or the control period start (PRE), one week before the competition (MID), after the competition (COMP) and after a recovery period (POST). During COMP-POST the participants are advised to continue training, but to stop competition dieting."Measurements will include body composition (fat mass and fat free mass by bioimpedance, DXA and skinfolds), resting metabolic rate (indirect calorimetry), vastus lateralis and triceps brachii muscle-cross sectional area, subcutaneous fat thickness from ultrasonography and circulating hormone analysis. Also, whole blood will be analyzed for hemoglobin and hematocrit and systems biology approach: e.g. serum metabolome and possibly also other analysis. Lower body maximal voluntary isometric force will be measured via knee extension machine device. Average weekly physical activity will be determined with a wrist-worn uni-axial accelerometer. Training and dietary data (nutrient intake, volume, intensity etc.) will be collected via nutrition and training diaries. Psychological questionnaires will be conducted via an online survey.

Detailed description: The purpose of this study is to evaluate the effects of competition preparation and recovery period on body composition, the endocrine system, metabolic rate, physical activity and performance, dietary and training habits and mood state in fitness athletes.

Metabolic and hormonal adaptations due to weight loss oppose further weight loss and pose challenges for maintaining reduced body weight. Fitness competition preparation (i.e., a substantial decrease in body fat mass without notable decreases in muscle mass) is accomplished by restricting total daily energy intake and increasing dosage of aerobic exercise dosage while maintaining high levels of resistance training and dietary protein. There is sparse research regarding the effects of the competition preparation and the recovery period afterwards the competition on body composition, neuromuscular performance, hormone balance, and metabolic rate. Additionally, the effects of preparation on mood states and on systems biology is not well studied.

The present study will help us understand the degree to which adaptations are due to the preparation and recovery process, or as a consequence of reaching the desired body composition (or some combination thereof). In turn, the findings may serve to help develop coaching guidelines for fitness athletes which minimize unfavorable adaptations to preparation and minimize the stress of the process. Participants will be notified of the research procedures, requirements, benefits and risks before providing written informed consent. The study will include one doctoral thesis and four scientific research articles during 2020-2024. Measurements of the study will be conducted during the spring of 2019 and 2020. Analyzing the results will occur during the year 2021 and the scientific publications will be reported by the end of 2024. The study is funded externally by the Finnish Fitness Sports Association and we will apply to additional, appropriate research grants. A large amount of data will be collected and processed which requires good management and leadership. In order to avoid risks, a comprehensive data management plan will be made for the study.

Eligibility criteria: Inclusion Criteria:

* two or more years of resistance training experience,
* participants must be 22-40 years old
* No 3 shiftwork
* Participants must be preparing for the Finnish Fitness Sports Association's national championships 2019 in the bodybuilding or men's or women´s divisions to be eligible intervention group.

Exclusion Criteria:

* diagnosed with chronic diseases
* prescribed medications
* using performance-enhancing drugs
* competing in the bodybuilding or men's fitness divisions autumn 2019 or 2020
* competing junior or master categories
* competing at non-drug tested competitions

Primary outcomes:
measure: Change in body composition during the competition preparation and after the recovery period
timeFrame: (-25 week, -1 week, +1-day, +25 week)
Secondary outcomes:
measure: Change in physical performance during the competition preparation and after the recovery period
timeFrame: (-25 week, -1 week, +25 week)
measure: Change in physical activity and training diaries during the competition preparation and after the recovery period
timeFrame: -25-week, -20-wee, 16-week, -12-week, -8-week, -4-week, -1week, +1-week +4-week, +8-wee, +12-week, +16-week, +20-week, +25-week
measure: Change in resting metabolic rate during the competition preparation and after the recovery period
timeFrame: (-25 week, -1 week, +25 week)
measure: Change in different omics in during the competition preparation and after the recovery period
timeFrame: (-25 week, -1 week, +1-day, +25 week)
measure: Chance in muscle subcutaneuous fat thickness in vastus lateralis muscle during the competition preparation and after the recovery period
timeFrame: (-25 week, -1 week, +1-day, +25 week)
measure: Change in hormonal balance during the competition preparation and after the recovery period
timeFrame: (-25 week, -1 week, +1-day, +25 week)
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: University of Jyväskylä
Study officials:
affiliation: Faculty od Sport and Health Sciences, University of Jyväskylä, Finland
name: Juha P Ahtiainen, PhD
role: STUDY_DIRECTOR
References:
citation: Hulmi JJ, Isola V, Suonpaa M, Jarvinen NJ, Kokkonen M, Wennerstrom A, Nyman K, Perola M, Ahtiainen JP, Hakkinen K. The Effects of Intensive Weight Reduction on Body Composition and Serum Hormones in Female Fitness Competitors. Front Physiol. 2017 Jan 10;7:689. doi: 10.3389/fphys.2016.00689. eCollection 2016.