NCT03702205

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2018

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2021

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

2.7 years

First QC Date

October 8, 2018

Last Update Submit

September 15, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Changes in fat mass and fat free mass after betaine supplementation

    Fat mass (kg) and fat free mass (kg) analysis

    Baseline and after 3 weeks

  • Changes in anaerobic capacity after betaine supplementation

    The Wingate cycling test (W)

    Baseline and after 3 weeks

  • Changes in specific performance capacity after betaine supplementation

    The CrossFit-specific physical fitness test: Fight Gone Bad (reps.)

    Baseline and after 3 weeks

Secondary Outcomes (6)

  • Changes in total body water after betaine supplementation

    Baseline and after 3 weeks

  • Changes in testosterone level (ng/L) after betaine supplementation

    Baseline and after 3 weeks

  • Changes in amino acid profile after betaine supplementation

    Baseline and after 3 weeks

  • Changes in blood betaine

    Baseline and after 3 weeks

  • Changes in total, LDL and HDL cholesterol and triacylglycerol after betaine supplementation

    Baseline and after 3 weeks

  • +1 more secondary outcomes

Study Arms (2)

Betaine supplementation

EXPERIMENTAL

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).

Dietary Supplement: Betaine supplementationDietary Supplement: Placebo treatment

Placebo treatment

EXPERIMENTAL

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).

Dietary Supplement: Betaine supplementationDietary Supplement: Placebo treatment

Interventions

Betaine supplementationDIETARY_SUPPLEMENT

Group taking oral betaine supplementation

Betaine supplementationPlacebo treatment
Placebo treatmentDIETARY_SUPPLEMENT

Group taking oral supplementation with placebo (starch) in a similar capsule form.

Betaine supplementationPlacebo treatment

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences

Poznan, 60-624, Poland

RECRUITING

Related Publications (1)

  • 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.

Study Officials

  • Agata Chmurzyńska, Professor

    Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences, Poznan, Poland

    STUDY DIRECTOR

Central Study Contacts

Krzysztof Durkalec-Michalski, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 10, 2018

Study Start

October 15, 2018

Primary Completion

June 20, 2021

Study Completion

October 12, 2021

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations