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NCT04585295 · ClinicalTrials.gov registry record · NA
The Effects of Pre-Loaded Betaine Supplementation on Thermoregulation and Exercise Metabolism in the Heat
A NA study of Healthy, sponsored by Florida State University.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT04585295: Completed NA study of Healthy, sponsored by Florida State University.
NCT04585295 is a NA study of Healthy that has completed, run by Florida State University. The registered enrollment target is 14 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04585295, a NA study of Healthy, has completed, sponsored by Florida State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a double blind, placebo-controlled, randomized, counterbalanced, crossover study designed to assess the impact of preloaded betaine supplementation on thermoregulation and exercise metabolism in the heat. The study, outlined in Figure 7 and described in detail below, will consist of seven total visits to the Institute of Sports Science and Medicine (ISSM) or Sandels laboratories at Florida State University, two of which will be experimental visits. On the first visit, participants will be informed as to the details of the study before giving their oral and written informed consent (Appendix A). Thereafter, anthropometrics will be measured and participants will complete an incremental exercise test on an electronically-braked cycle ergometer to volitional exhaustion to determine peak oxygen consumption (VO2 peak). 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, with the last dosage being consumed 60 minutes prior to experimental visits, days 7 and 21. On days 2 and 4, familiarization trials will be completed to standardize training loads and to reduce any potential learning effect. These visits will be implemented in the heat. On day 7, participants will complete the first experimental trial described in detail below. Afterwards, participants will enter a seven day washout period 167 before crossing over to the second supplemental condition on day 14. On days 16 and 18, participants will undergo the same familiarization trials as they did on days 2 and 4. On day 21, participants will complete their second experimental trial. Each experimental trial will be separated by 14 days. This study will be approved by the Florida State University Insitutional Review Board (Appendix B).
Primary Outcome
Intracellular fluid volume (L), extracellular fluid volume (L), plasma volume (L), total body water (L)
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Betaine
- DIETARY_SUPPLEMENT BCAA Big 6
Study Locations (1)
Florida
- Institute of Sport Sciences and Medicine at Florida State University - Tallahassee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-01-21 |
| Est. Completion | 2023-12-15 |
| Phase | NA |
What the finished NCT04585295 record still lists
NCT04585295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04585295 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04585295 about?
NCT04585295 is a clinical study titled "The Effects of Pre-Loaded Betaine Supplementation on Thermoregulation and Exercise Metabolism in the Heat". This will be a double blind, placebo-controlled, randomized, counterbalanced, crossover study designed to assess the impact of preloaded betaine supplementation on thermoregulation and exercise metabolism in the heat. The study, outlined in Figure 7 and described in detail below, will consist of sev...
What is the current status of trial NCT04585295?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2020-01-21. Estimated completion is 2023-12-15.
What conditions does trial NCT04585295 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT04585295?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Betaine (DIETARY_SUPPLEMENT), BCAA Big 6 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04585295?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04585295 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04585295's enrollment target sits among peer trials
14 974th of 1090 higher than 106 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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