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Betaine Supplementation for Healthy Subjects

N/A
Waitlist Available
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre and post 7 days of supplementation & minutes 0, 15, 30, 45, 60, 75, and 90 during the experimental visit
Awards & highlights

Study Summary

This trial will study the effect of preloaded betaine supplementation on thermoregulation and exercise metabolism in the heat. The study will consist of seven visits, two of which will be experimental. On the first visit, participants will be given details of the study and anthropometrics will be measured. Thereafter, an incremental exercise test will be done to determine peak oxygen consumption. On days 1-6, participants will consume a full dosage of supplementation, whereas day 0 and 7 participants will consume half a dose of the supplement. On days 2 and 4, familiarization trials will be completed. On day 7, participants will complete the first experimental trial

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre and post 7 days of supplementation & minutes 0, 15, 30, 45, 60, 75, and 90 during the experimental visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre and post 7 days of supplementation & minutes 0, 15, 30, 45, 60, 75, and 90 during the experimental visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fluid Compartment Volumes (Bioelectrical Impedance Spectrocopy)
Thermoregulation (core temperature pills, skin temperature sensors)
Thermoregulation (enzyme linked immunoassays)
+1 more
Secondary outcome measures
Exercise Metabolism and Performance (Oxygen Consumption)
Exercise Metabolism and Performance (heart rate)

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

3Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment3 Interventions
Aim 1: To evaluate the impact of preloaded betaine supplementation on fluid compartments in male athletes aged 18-45 years old. Aim 2: To determine the degree to which preloading with betaine impacts heat tolerance relative to placebo in male athletes aged 18-45 years old. Aim 3: To determine the degree to which preloading with betaine impacts exercise metabolism and performance in the heat relative to placebo in male athletes aged 18-45 years old.
Group II: NOW Foods Big 6Experimental Treatment3 Interventions
Aim 1: To evaluate the impact of preloaded betaine supplementation on fluid compartments in male athletes aged 18-45 years old. Aim 2: To determine the degree to which preloading with betaine impacts heat tolerance relative to placebo in male athletes aged 18-45 years old. Aim 3: To determine the degree to which preloading with betaine impacts exercise metabolism and performance in the heat relative to placebo in male athletes aged 18-45 years old.
Group III: BetaineExperimental Treatment3 Interventions
Aim 1: To evaluate the impact of preloaded betaine supplementation on fluid compartments in male athletes aged 18-45 years old. Aim 2: To determine the degree to which preloading with betaine impacts heat tolerance relative to placebo in male athletes aged 18-45 years old. Aim 3: To determine the degree to which preloading with betaine impacts exercise metabolism and performance in the heat relative to placebo in male athletes aged 18-45 years old.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Betaine
2013
Completed Phase 4
~280
BCAA Big 6
2020
N/A
~20
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Florida State UniversityLead Sponsor
199 Previous Clinical Trials
31,677 Total Patients Enrolled
NOW FoodsOTHER
5 Previous Clinical Trials
677 Total Patients Enrolled
Miachael Ormsbee, PhDStudy DirectorFlorida State University

Media Library

BCAA Big 6 Clinical Trial Eligibility Overview. Trial Name: NCT04585295 — N/A
BCAA Big 6 2023 Treatment Timeline for Medical Study. Trial Name: NCT04585295 — N/A

Frequently Asked Questions

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

What is the maximum capacity for participants in this trial?

"Affirmative. The clinicaltrials.gov website indicates that this medical trial, which was initially listed on January 21st 2020, is currently enrolling patients for participation. 13 individuals must be accepted from 1 site to complete the study."

Answered by AI

Are there any opportunities to enroll in this scientific research project?

"Affirmative, the clinicaltrials.gov registry reveals that this research is presently enrolling individuals. The project was first made public on January 21st 2020 and the most recent update occurred November 7th 2022; 13 participants are needed from a single clinic."

Answered by AI

Does this research encompass geriatric individuals?

"The specific guidelines for this research require participants to be between 18 and 45 years of age. For people younger than the former or older than the latter, there are 50 trials available respectively."

Answered by AI

Is there any way I can participate in this clinical research?

"This study will include up to 13 participants aged from 18-45 who are currently classified as healthy subjects (hs). Prospective patients must also meet the following requirements: Age of consent to 45 years old and have at least 3 years experience in cycling."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Institute of Sport Sciences and Medicine at Florida State University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The Effects of Pre-Loaded Betaine Supplementation on Thermoregulation and Exercise Metabolism in the Heat
Michael J. Ormsbee 2020. "The Effects of Pre-Loaded Betaine Supplementation on Thermoregulation and Exercise Metabolism in the Heat". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04585295.
~3 spots leftby Apr 2025
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