Weight ReductionNCT04392752
Fitness Study 2020
A study testing Dieting intervention in people with Weight Reduction and Diet; Deficiency, run by University of Jyvaskyla at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Weight Reduction, Diet; Deficiency
- What is being tested?
- Dieting intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- 2 Feb 2019to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Fitness Competition Period on Body Composition, Neuromuscular Performance, Physiological and Psychological Factors in Fitness Athletes
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.
Read the 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.
- Conditions
- Weight Reduction, Diet; Deficiency
- Being tested
- Dieting intervention
- Medical subject headings
- Weight Loss, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dieting interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | 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. Receives: Other: Dieting intervention |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: (-25 week, -1 week, +1-day, +25 week)
Secondary outcomes (6)
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.
Measured: (-25 week, -1 week, +25 week)
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.
Measured: -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
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.
Measured: (-25 week, -1 week, +25 week)
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.
Measured: (-25 week, -1 week, +1-day, +25 week)
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-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.
Measured: (-25 week, -1 week, +1-day, +25 week)
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.
Measured: (-25 week, -1 week, +1-day, +25 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start2 Feb 2019
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Weight ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare
- Responsible party
- Principal investigator, Ville Isola, University of Jyvaskyla
- Investigators
- Juha P Ahtiainen, PhD, Study director, Faculty od Sport and Health Sciences, University of Jyväskylä, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392752
- Sponsor's protocol ID
- fitnessjyvaskyla
- Status last verified
- May 2020
- First submitted
- 25 Sep 2019
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28119632Mikkonen R, Hackney AC, Hulmi J, Isola V, Ahtiainen J, Ihalainen J. Hormone Profiles After Planned Low Energy Availability Exposure in Naturally Menstruating and Hormonal Contraceptive Using Physique Athletes. Eur J Sport Sci. 2025 Dec;25(12):e70076. doi: 10.1002/ejsc.70076.
PubMed 41235908Isola V, Hulmi JJ, Petaja P, Helms ER, Karppinen JE, Ahtiainen JP. Weight loss induces changes in adaptive thermogenesis in female and male physique athletes. Appl Physiol Nutr Metab. 2023 Apr 1;48(4):307-320. doi: 10.1139/apnm-2022-0372. Epub 2023 Jan 16.
PubMed 36645885
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Fitness Competition Period on Body Composition, Neuromuscular Performance, Physiological and Psychological Factors in Fitness Athletes
- ClinicalTrials.gov ID
- NCT04392752
- Acronym / sponsor ID
- fitnessjyvaskyla
- Conditions
- Weight Reduction, Diet; Deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Other: Dieting interventionThe 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. |
| Control | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dieting interventionThis 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. | Other | Participants |
Primary outcome
Change in body composition during the competition preparation and after the recovery period
Time frame: (-25 week, -1 week, +1-day, +25 week)
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.
6 secondary outcomes
Change in physical performance during the competition preparation and after the recovery period
Time frame: (-25 week, -1 week, +25 week)
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
Change in resting metabolic rate during the competition preparation and after the recovery period
Time frame: (-25 week, -1 week, +25 week)
Change in different omics in during the competition preparation and after the recovery period
Time frame: (-25 week, -1 week, +1-day, +25 week)
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)
Change in hormonal balance during the competition preparation and after the recovery period
Time frame: (-25 week, -1 week, +1-day, +25 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Background: PubMed 28119632Hulmi 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.
- Derived from this study: PubMed 41235908Mikkonen R, Hackney AC, Hulmi J, Isola V, Ahtiainen J, Ihalainen J. Hormone Profiles After Planned Low Energy Availability Exposure in Naturally Menstruating and Hormonal Contraceptive Using Physique Athletes. Eur J Sport Sci. 2025 Dec;25(12):e70076. doi: 10.1002/ejsc.70076.
- Derived from this study: PubMed 36645885Isola V, Hulmi JJ, Petaja P, Helms ER, Karppinen JE, Ahtiainen JP. Weight loss induces changes in adaptive thermogenesis in female and male physique athletes. Appl Physiol Nutr Metab. 2023 Apr 1;48(4):307-320. doi: 10.1139/apnm-2022-0372. Epub 2023 Jan 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juha P Ahtiainen, PhD study director
Faculty od Sport and Health Sciences, University of Jyväskylä, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dieting intervention in people with Weight Reduction and Diet; Deficiency, run by University of Jyvaskyla at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body composition during the competition preparation and after the recovery period (time frame: (-25 week, -1 week, +1-day, +25 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04392752, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020; AzTrials last refreshed its copy on 29 Oct 2026.