The Effects of Pre-Loaded Betaine Supplementation on Thermoregulation and Exercise Metabolism in the Heat

NCT04585295 | Completed

• 1 other identifier: Betaine
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy

Keywords

Betaine; NOW Foods BCAA Big 6; Placebo

Outcome Measures

Primary Outcomes (4)

• Fluid Compartment Volumes (Bioelectrical Impedance Spectrocopy)

  Intracellular fluid volume (L), extracellular fluid volume (L), plasma volume (L), total body water (L)

  pre and post 7 days of supplementation

• Thermoregulation (core temperature pills, skin temperature sensors)

  Core temperature (Degrees C), skin temperature (Degrees C)

  pre and post 7 days of supplementation & minutes 0, 15, 30, 45, 60, 75, and 90 during the experimental visit

• Thermoregulation (enzyme linked immunoassays)

  serum expression of heat shock protein 72 and plasma lipopolysaccharide concentrations

  7 days of supplementation & minutes 0, 30, 60, and 90 during the experimental visit

• Thermoregulation (thermal sensation scale)

  Subjective self-reported assessment of perceived thermal sensation (arbitrary units)

  minutes 0, 15, 30, 45, 60, 75, and 90 during the experimental visit

Secondary Outcomes (2)

• Exercise Metabolism and Performance (heart rate)

  minutes 0, 15, 30, 45, 60, 75, and 90 during the experimental visit

• Exercise Metabolism and Performance (Oxygen Consumption)

  minutes 0-5, 25-30, and 55-60 during the experimental visit

Study Arms (3)

Betaine

EXPERIMENTAL

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.

Dietary Supplement: Betaine; Dietary Supplement: BCAA Big 6; Dietary Supplement: Placebo

Placebo

EXPERIMENTAL

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.

Dietary Supplement: Betaine; Dietary Supplement: BCAA Big 6; Dietary Supplement: Placebo

NOW Foods Big 6

EXPERIMENTAL

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.

Dietary Supplement: Betaine; Dietary Supplement: BCAA Big 6; Dietary Supplement: Placebo

Interventions

Betaine DIETARY_SUPPLEMENT

50 mg/kg Betaine consumed twice daily for 7 days.

Also known as: Trimethylglycine

Betaine; NOW Foods Big 6; Placebo

BCAA Big 6 DIETARY_SUPPLEMENT

1 level scoop (\~18 g) of NOW Foods BCAA Big 6, consumed once per day for 7 days.

Betaine; NOW Foods Big 6; Placebo

Placebo DIETARY_SUPPLEMENT

50 mg/kg Placebo consumed twice daily for 7 days.

Betaine; NOW Foods Big 6; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sex: male
• Age: 18-45 yr
• Trained male cyclists: ≥ 3 yr cycling experience
• Participants' VO2 peak \> 50.0 ml·kg·min-1

You may not qualify if:

• Sex: female
• Age: \< 18 yr or \> 45 yr
• Cigarette smoking: current cigarette smoker or those who quit within the previous 6 months
• Participants' VO2 peak \< 50.0 ml·kg·min-1
• Participants consuming supplements known to impact hydration status and exercise performance
• Participants known to have sickle cell trait or disease

Sponsors & Collaborators

• Florida State University: lead
• NOW Foods: collaborator

Study Sites (1)

Institute of Sport Sciences and Medicine at Florida State University

Tallahassee, Florida, 32304, United States

Location

MeSH Terms

Interventions

Betaine

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Miachael Ormsbee, PhD

  Florida State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: October 14, 2020
• Study Start: January 21, 2020
• Primary Completion: August 15, 2023
• Study Completion: December 15, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)