Fitness Study 2020

Weight Reduction Clinical Trial

Official title:

Effects of the Fitness Competition Period on Body Composition, Neuromuscular Performance, Physiological and Psychological Factors in Fitness Athletes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04392752
• Other study ID #: fitnessjyvaskyla
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: May 2020
• Source: University of Jyvaskyla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diet; Deficiency
• Malnutrition
• Weight Loss
• Weight Reduction

Intervention

Other:
• Dieting intervention
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.

Locations

Country	Name	City	State
Finland	University of Jyväskylä	Jyväskylä

Sponsors (2)

Lead Sponsor	Collaborator
University of Jyvaskyla	National Institute for Health and Welfare, Finland

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Hulmi JJ, Isola V, Suonpää M, Järvinen NJ, Kokkonen M, Wennerström A, Nyman K, Perola M, Ahtiainen JP, Häkkinen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body composition during the competition preparation and after the recovery period	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.	(-25 week, -1 week, +1-day, +25 week)
Secondary	Change in physical performance during the competition preparation and after the recovery period	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.	(-25 week, -1 week, +25 week)
Secondary	Change in physical activity and training diaries during the competition preparation and after the recovery period	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.	-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
Secondary	Change in resting metabolic rate during the competition preparation and after the recovery period	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.	(-25 week, -1 week, +25 week)
Secondary	Change in different omics in during the competition preparation and after the recovery period	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.	(-25 week, -1 week, +1-day, +25 week)
Secondary	Chance in muscle subcutaneuous fat thickness in vastus lateralis muscle during the competition preparation and after the recovery period	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-a10, Aloka, Tokyo, Japan) with a 10 MHz linear-array probe (60 mm width) in extended-?eld-of-view mode (23 Hz sampling frequency). There will be 4 measurements.	(-25 week, -1 week, +1-day, +25 week)
Secondary	Change in hormonal balance during the competition preparation and after the recovery period	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.	(-25 week, -1 week, +1-day, +25 week)