Clinical trial NCT03702205: Betaine Effect in Speed-strength Athletes
Official title: The Effect of Betaine Supplementation on Body Composition and Physical Capacity of Speed-strength Male Athletes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Supplementation
Sport
Lead sponsor: Poznan University of Life Sciences
Sponsor class: OTHER
Collaborators: name: National Science Centre, Poland
First posted: 2018-10-10
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is aimed at assessing the influence of two betaine doses (2.5 g∙d-1 and 5 g∙d-1) supplemented for three weeks in a group of speed-strength trained athletes on anaerobic capacity in Wingate test, performance in CrossFit-like exercise test - Fight Gone Bad, alterations in body compositions and total body water.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in fat mass and fat free mass after betaine supplementation
timeFrame: Baseline and after 3 weeks
measure: Changes in anaerobic capacity after betaine supplementation
timeFrame: Baseline and after 3 weeks
measure: Changes in specific performance capacity after betaine supplementation
timeFrame: Baseline and after 3 weeks
Secondary outcomes:
measure: Changes in total body water after betaine supplementation
timeFrame: Baseline and after 3 weeks
measure: Changes in testosterone level (ng/L) after betaine supplementation
timeFrame: Baseline and after 3 weeks
measure: Changes in amino acid profile after betaine supplementation
timeFrame: Baseline and after 3 weeks
measure: Changes in blood betaine
timeFrame: Baseline and after 3 weeks
measure: Changes in total, LDL and HDL cholesterol and triacylglycerol after betaine supplementation
timeFrame: Baseline and after 3 weeks
measure: Difference in response to betaine supplementation depending on MTHFR (rs1801133) polymorphism
timeFrame: Baseline and after 3 weeks
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences
Study officials:
affiliation: Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences, Poznan, Poland
name: Agata Chmurzyńska, Professor
role: STUDY_DIRECTOR
References: