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Dietary Supplement

Betaine for Metabolic Disorders

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

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

Study 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.

Select...

I am between 18-65 years old and can cycle 60km at a challenging pace.

Timeline

Screening ~ 3 weeks3 visits

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

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

Chest pain

100%

80%

60%

40%

20%

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

~280

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Appalachian State UniversityLead Sponsor

41 Previous Clinical Trials

2,197 Total Patients Enrolled

AGRANAUNKNOWN

David C Nieman, DrPHPrincipal InvestigatorAppalachian State Univ

14 Previous Clinical Trials

660 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to partake in this experimental study?

"Patients aged between 18 and 65 with metabolic abnormalities are eligible for participation in this research, which aims to enroll approximately 27 individuals."

Answered by AI

What is the total number of individuals who are currently enrolled as participants in this medical study?

"Indeed, as per the details on clinicaltrials.gov, this research endeavor is actively in search of suitable candidates. The trial was originally listed on May 13th, 2024 and underwent its latest update on April 26th, 2024. Recruitment aims to enlist a total of 27 participants distributed across two designated sites."

Answered by AI

Is the clinical trial seeking participation from individuals aged 65 and above?

"Eligible candidates for this research are individuals aged between 18 and 65. It is worth noting that there are separate clinical trials available for those under 18 as well as those over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Betaine, Exercise Performance, and Gut Permeability

2024. "Betaine, Exercise Performance, and Gut Permeability". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06392360.

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