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Dietary Supplement

Betaine for Exercise Performance

N/A
Recruiting
Led By David C Nieman, DrPH
Research Sponsored by Appalachian State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-smoker, generally healthy without gastrointestinal diseases or chronic diseases including cardiovascular disease, cancer, type 1 and 2 diabetes, rheumatoid arthritis
Male or female cyclists, ages 18-65 years, capable of cycling 60-km in the laboratory at 70% VO2max
Must not have
Females trying to become pregnant, currently pregnant or breastfeeding
Nonpregnant adults who weigh less than 110 pounds
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise
Awards & highlights

Summary

This trial will investigate whether taking 3 grams of betaine daily for two weeks before a 60-km cycling race can improve performance, reduce gut issues during exercise, and help with recovery after the

Who is the study for?
This trial is for male and female cyclists aged 18-65 who can cycle 60 km at a certain intensity. They must not smoke, be generally healthy without chronic diseases like heart disease or diabetes, and agree to dietary restrictions and exercise tapering before lab sessions.Check my eligibility
What is being tested?
The study tests if taking betaine (3 g/d) improves cycling performance, reduces gut permeability from exercise, and aids metabolic recovery compared to a placebo. Participants will prepare with two weeks of either betaine or placebo before a demanding 60-km cycling trial.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include sensitivity reactions to betaine for those with a history of such issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a non-smoker and do not have chronic diseases like heart disease, diabetes, or arthritis.
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I am between 18-65 years old and can cycle 60km at a challenging pace.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am trying to get pregnant, am currently pregnant, or am breastfeeding.
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I am not pregnant and weigh less than 110 pounds.
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I have a current diagnosis of GI, heart disease, diabetes, or cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Exercise Performance
Secondary outcome measures
Changes in plasma gut permeability sugars including mannitol, lactulose, rhamnose, and sucrose from targeted metabolomics using LC-MS/MS analysis (relative intensities)
Gut permeability

Side effects data

From 2014 Phase 4 trial • 60 Patients • NCT01749982
13%
Diarrhea
13%
Fever
7%
Chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Choline Bitartrate
Betaine
Choline Bitartrate + Betaine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BetaineExperimental Treatment1 Intervention
3 grams per day in 6 capsules, white crystalline betaine powder produced from beet molasses
Group II: PlaceboPlacebo Group1 Intervention
3 grams per day in 6 capsules, white cellulose powder
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Betaine
2013
Completed Phase 4
~330

Find a Location

Who is running the clinical trial?

Appalachian State UniversityLead Sponsor
42 Previous Clinical Trials
2,235 Total Patients Enrolled
AGRANAUNKNOWN
David C Nieman, DrPHPrincipal InvestigatorAppalachian State Univ
14 Previous Clinical Trials
660 Total Patients Enrolled
~7 spots leftby Sep 2024