Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
80 participants
INTERVENTIONAL
2018-10-15
2021-10-12
Brief Summary
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Detailed Description
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The study is designed as a double-blind, randomized, placebo-controlled crossover trial. 80 male participants will be divided randomly into two parallel groups: one receiving 2.5 g·d-1 betaine and the second receiving 5 g·d-1 betaine. In both experimental groups participants will receive both betaine supplement or placebo in a random order. The supplementation periods (betaine and placebo) will last for three weeks each and will be separated by a 3-week washout. The participants will attend four study meetings at the Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences, Poland. Food intake before and during the intervention will be assessed with the use of food diary and intakes of macro- and micronutrients will be calculated with the use of Dieta 5.0 software. On each visit Wingate ergocycling test will be performed, body composition will be measured and blood samples will be taken. The same day in the afternoon/evening hours the Fight Gone Bad (FGB) test will be performed. Body composition will be assessed based on air displacement plethysmography technology using the Bod Pod®. Moreover, total body water content will be analyzed by bioelectric impedance with the use of a BIA 101S analyzer. Anaerobic capacity will be assessed using the classical Wingate test on a cycloergometer. In order to assess CrossFit performance the FGB test will be performed. In blood samples the investigators plan to analyze concentrations of: lipoproteins and triglycerides (biochemical analyzer), betaine (LC-MS method), amino acid profile (LC-MS method), and testosterone (ELISA). MTHFR genotype will be analyzed with using a PCR-RFLP method. Data will be analyzed using the STATISTICA 12 software program.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Betaine supplementation
The experimental procedure for each athlete includes a 3-week betaine supplementation either 2.5 g or 5 g daily. Betaine will be administered in the form of capsules containing either 0.5 or 1 g betaine. The capsules will be ingested with at least 250 mL of water. Each athlete will ingest 5 betaine capsules a day. On training days the supplements will be taken in the morning (2 capsules), in the evening (2 capsules) and 1.5 hours before training session (1 capsule). On rest days the supplements will be taken in the morning (2 capsules), in the afternoon (1 capsule) and in the evening (2 capsules).
Betaine supplementation
Group taking oral betaine supplementation
Placebo treatment
Group taking oral supplementation with placebo (starch) in a similar capsule form.
Placebo treatment
The experimental procedure for each athlete included a 3-week placebo administration. Placebo will be capsules with starch. Placebo will be ingested with at least 250 mL of water. Each athlete will ingest 5 placebo capsules a day. On training days the supplements will be taken in the morning (2 capsules), in the evening (2 capsules) and 1.5 hours before training session (1 capsule). On rest days the supplements will be taken in the morning (2 capsules), in the afternoon (1 capsule) and in the evening (2 capsules).
Betaine supplementation
Group taking oral betaine supplementation
Placebo treatment
Group taking oral supplementation with placebo (starch) in a similar capsule form.
Interventions
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Betaine supplementation
Group taking oral betaine supplementation
Placebo treatment
Group taking oral supplementation with placebo (starch) in a similar capsule form.
Eligibility Criteria
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Inclusion Criteria
* a current medical clearance to practice sports,
* training experience: at least 1 year (of CrossFit ttraining),
* minimum of 2 workout sessions (combat sport) a week,
Exclusion Criteria
* any health-related contraindication,
* declared general feeling of being unwell,
* unwilling to follow the study protocol,
* serious disease or metabolic problems,
* intake of betaine, choline or creatine supplements 4 weeks before the beginning of the study.
18 Years
35 Years
MALE
Yes
Sponsors
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National Science Centre, Poland
OTHER_GOV
Poznan University of Life Sciences
OTHER
Responsible Party
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Principal Investigators
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Agata Chmurzyńska, Professor
Role: STUDY_DIRECTOR
Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences, Poznan, Poland
Locations
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Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences
Poznan, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Zawieja E, Durkalec-Michalski K, Sadowski M, Glowka N, Chmurzynska A. Betaine supplementation improves CrossFit performance and increases testosterone levels, but has no influence on Wingate power: randomized crossover trial. J Int Soc Sports Nutr. 2023 Dec;20(1):2231411. doi: 10.1080/15502783.2023.2231411.
Other Identifiers
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ULS00005
Identifier Type: -
Identifier Source: org_study_id
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