- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03702205
Betaine Effect in Speed-strength Athletes
The Effect of Betaine Supplementation on Body Composition and Physical Capacity of Speed-strength Male Athletes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The main aim of the project is the assessment of the effects of 3 weeks supplementation with two doses of betaine (2.5 g∙d-1 and 5 g∙d-1) on anaerobic capacity, CrossFit performance, body composition, and betaine metabolism in a group of male speed-strength trained athletes.
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Emilia E Zawieja, MSc
- Phone Number: +48 61 846 60 57
- Email: emilia.zawieja@up.poznan.pl
Study Contact Backup
- Name: Krzysztof Durkalec-Michalski, PhD
- Phone Number: +48 618 487 338
- Email: durkmich@up.poznan.pl
Study Locations
-
-
-
Poznań, Poland, 60-624
- Recruiting
- Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences
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Contact:
- Emilia E Zawieja, MSc
- Phone Number: +48 61 846 60 57
- Email: emilia.zawieja@up.poznan.pl
-
Principal Investigator:
- Emilia Zawieja, MSc
-
Principal Investigator:
- Krzysztof Durkalec-Michalski, PhD
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Principal Investigator:
- Agata Chmurzyńska, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- written informed consent from all participants before the study
- 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:
- current injury,
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
|
Group taking oral betaine supplementation
Group taking oral supplementation with placebo (starch) in a similar capsule form.
|
Experimental: 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).
|
Group taking oral betaine supplementation
Group taking oral supplementation with placebo (starch) in a similar capsule form.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in fat mass and fat free mass after betaine supplementation
Time Frame: Baseline and after 3 weeks
|
Fat mass (kg) and fat free mass (kg) analysis
|
Baseline and after 3 weeks
|
Changes in anaerobic capacity after betaine supplementation
Time Frame: Baseline and after 3 weeks
|
The Wingate cycling test (W)
|
Baseline and after 3 weeks
|
Changes in specific performance capacity after betaine supplementation
Time Frame: Baseline and after 3 weeks
|
The CrossFit-specific physical fitness test: Fight Gone Bad (reps.)
|
Baseline and after 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in total body water after betaine supplementation
Time Frame: Baseline and after 3 weeks
|
Total body water content (%)
|
Baseline and after 3 weeks
|
Changes in testosterone level (ng/L) after betaine supplementation
Time Frame: Baseline and after 3 weeks
|
Testosterone level (ng/L)
|
Baseline and after 3 weeks
|
Changes in amino acid profile after betaine supplementation
Time Frame: Baseline and after 3 weeks
|
Amino acid profile (μmol/L)
|
Baseline and after 3 weeks
|
Changes in blood betaine
Time Frame: Baseline and after 3 weeks
|
Blood betaine (µmol/L)
|
Baseline and after 3 weeks
|
Changes in total, LDL and HDL cholesterol and triacylglycerol after betaine supplementation
Time Frame: Baseline and after 3 weeks
|
Total, LDL and HDL cholesterol (mg/dL) and triacylglycerol (mg/dL)
|
Baseline and after 3 weeks
|
Difference in response to betaine supplementation depending on MTHFR (rs1801133) polymorphism
Time Frame: Baseline and after 3 weeks
|
MTHFR (rs1801133) polymorphism
|
Baseline and after 3 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Agata Chmurzyńska, Professor, Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences, Poznan, Poland
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
- ULS00005
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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