- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04392752
Fitness Study 2020
Effects of the Fitness Competition Period on Body Composition, Neuromuscular Performance, Physiological and Psychological Factors in Fitness Athletes
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Jyväskylä, Finland, 40014
- University of Jyväskylä
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Participants
The participants are recruited via the University of Jyväskylä and Finnish Fitness Sports Association web page and social media channels.
An online pre-study questionnaire are sent to randomly chosen athletes and control group candidates who claim to fulfill the inclusion criteria and volunteer for the study.
The participants selected for the study filled an additional questionnaire which is subsequently reviewed by the physician of the study to confirm that they will meet inclusion criteria relating to health.
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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.
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No Intervention: Control
The target is 15 male ja 15 female participants for both the control and intervention groups.
To be included, participants need to be with two or more years of resistance training experience, similar to our previous study in females (Hulmi et al. 2017).
If more than 15+15 control participants sign up for the study, the final group will be matched to the intervention group based on age, height, weight, and training experience reported on the pre-study questionnaire.
The control group maintain their normal nutrition and training during the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body composition during the competition preparation and after the recovery period
Time Frame: (-25 week, -1 week, +1-day, +25 week)
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Fat mass (kg) will be estimated by Dual-energy X-ray absorptiometry (DXA, Lunar Prodigy Advance, GE Medical Systems-Lunar, Madison WI USA) using methods similar to Hulmi et al. (2015; 2017) in a fasted state.
The analysis (using enCORE 2005, version 9.30 and Advance 12.30) will provide total fat mass (kg).
There will be 3 measurements.
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(-25 week, -1 week, +1-day, +25 week)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in physical performance during the competition preparation and after the recovery period
Time Frame: (-25 week, -1 week, +25 week)
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Maximal isometric force (Nm) output of the knee extensors of the right leg is assessed using an isokinetic dynamometer (Type 9287, Kistler, Switzerland connected to Spike 2™ software.
There will be 3 measurements.
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(-25 week, -1 week, +25 week)
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Change in physical activity and training diaries during the competition preparation and after the recovery period
Time Frame: -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
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Mean weekly physical activity (MET) will be monitored using a wrist-worn uni-axial accelerometer Polar Active (Brugniaux et al. 2008).
The participants are to wear the Polar Active continuously during a 3-week periods.
The activity measurement last for 21 days.
During the activity measurement, the wrist-worn accelerometer is worn at all times, except in sauna or bath.
Polar Active uses sex, age, body mass, and height as an input to convert the measured acceleration signal to METs with the epoch length of 30 s. Polar Active has been found to correlate well (R2 = 0.74) with the doubly labeled water technique while assessing energy expenditure during a 7- day period of military training (Kinnunen et al., 2012).
Data will be collect every month.
There will be 14 measurements.
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-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
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Change in resting metabolic rate during the competition preparation and after the recovery period
Time Frame: (-25 week, -1 week, +25 week)
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Resting metabolic rate (J/h·kg) will be measured with indirect calorimetry via respiratory quotient (RQ) assessments.
Measurement is performed in a supine position over a 10-min period in a dark, thermos-neutral and quiet laboratory space.
Expired gases during the tests are continuously analyzed over the 10 min period (Compher et al. 2006).
There will be 3 measurements.
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(-25 week, -1 week, +25 week)
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Change in different omics in during the competition preparation and after the recovery period
Time Frame: (-25 week, -1 week, +1-day, +25 week)
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A high-throughput serum Nuclear Magnetic Resonance (NMR) metabolomics platform will be used for the absolute quantification of serum lipids and metabolite profile.
The NMR metabolome assay yields a total of 228 different metabolites, including an array of lipoprotein subclasses (e.g., VLDL, LDL, HDL), apolipoproteins, A-1 and B-100, serum free fatty acids, and a wide variety of small molecules such as glycolysis precursors, amino acids and inflammation biomarkers.
In the platform, lipoproteins are divided into subclasses according to particle size.
Serum metabolics will be quantified from acquired fasting blood samples by Brainshake (Finland) company, specializing in metabolomics quantification.
Further, statistical analysis of provided data will be handled at Genomics and biomarkers unit, Institute for Health and Welfare (THL, Finland).
There will be 4 measurements.
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(-25 week, -1 week, +1-day, +25 week)
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Chance in muscle subcutaneuous fat thickness in vastus lateralis muscle during the competition preparation and after the recovery period
Time Frame: (-25 week, -1 week, +1-day, +25 week)
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Vastus lateralis subcutaneous fat thickness (mm) will be examined (Hulmi et al. 2017) at the mid-thigh will be assessed using a B-mode axial plane ultrasound (model SSD-α10, Aloka, Tokyo, Japan) with a 10 MHz linear-array probe (60 mm width) in extended-field-of-view mode (23 Hz sampling frequency).
There will be 4 measurements.
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(-25 week, -1 week, +1-day, +25 week)
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Change in hormonal balance during the competition preparation and after the recovery period
Time Frame: (-25 week, -1 week, +1-day, +25 week)
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Free thyroxine (pmol/l) will be analyzed from serum with the Immunolite 2000 XPi, immunoassay system (Seimen Healtineers, Erlangen Germany).There will be 4 measurements.
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(-25 week, -1 week, +1-day, +25 week)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Juha P Ahtiainen, PhD, Faculty od Sport and Health Sciences, University of Jyväskylä, Finland
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- fitnessjyvaskyla
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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