HealthyNCT04585295
The Effects of Pre-Loaded Betaine Supplementation on Thermoregulation and Exercise Metabolism in the Heat
A study testing Betaine and BCAA Big 6 in people with Healthy, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Betaine and BCAA Big 6
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2020to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sex: male
- Age: 18-45 yr
- Trained male cyclists: ≥ 3 yr cycling experience
- Participants' VO2 peak > 50.0 ml·kg·min-1
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Sport Sciences and Medicine at Florida State University
Tallahassee, Florida, 32304
About this study
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).
Read the detailed description
Initial Visit Participants will be asked to come into the ISSM in the morning, following an overnight fast (7-9 hr) having abstained from caffeine for the previous 12 hours, and having abstained from alcohol and exercise for the previous 24 hr. Participants will be asked to consume 6 ml·kg-1 water 60 minutes prior to arrival. Following the signing of the informed consent document, participants will be asked to change into athletic clothing. Thereafter, with shoes removed, participants' height will be assessed to the nearest cm via a wall-mounted scale (Seca, Hamburg, Germany). Participants will be weighed to the nearest 0.1 kg via an automated scale (Detecto® 750, Webb City, MO). Body composition will then be assessed via Bod Pod (Cosmed, Chicago, IL). Participants will be asked to rest quietly in a supine position for 5 minutes, before blood pressure will be measured via auscultation and sphygmomanometry (Grainger, Lake Forest, Illinois). While still in a supine position, fluid compartments will be measured via bioelectric impedance spectroscopy (BIS) (ImpediMed SFB7, ImpediMed Limited, Australia).
Following these baseline measurements, participants will be asked to wear a heart rate monitor then complete a self-determined 5-min warm-up on an electronically-braked cycle ergometer (Velotron, SRAM, Spearfish, SD). Immediately after the warm-up, participants will be fitted with a metabolic mask (TrueOne 2400 Metabolic Cart, ParvoMedics, Sandy, Utah) then commence an incremental exercise test to exhaustion. The incremental test will consist of 3-min stages in which the resistance will begin at a relative intensity of 2 W·kg-1 and increase in 25 W increments until RER is greater than 1.0. At this point, the test will switch to 1-min stages with resistance increasing in 10 W increments until volitional exhaustion. A similar protocol is described elsewhere 223.
Afterwards, participants will be provided with their blinded supplement and instructed to consume 50 mg·kg-1 twice daily (~12 hr apart) with 6 ml·kg-1 water each time, for 7 days.
Familiarization Trials The familiarization trials will occur the first week of supplementation on days 2 and 4, and the second week of supplementation on days 16 and 18. On familiarization days, participants will be asked to arrive at the Sandels building in the morning in a euhydrated state, having consumed 6 ml·kg-1 water 60 minutes prior to arrival. Additionally, participants will be asked to arrive following an overnight fast (7-9 hr) having abstained from caffeine for the previous 12 hours, and having abstained from alcohol and exercise for the previous 24 hr. Upon arrival, the participant will be fitted with a heart rate monitor (Polar® FT4M, Sempele, Finland). Participants will enter the chamber (33° C, 35% RH), be fitted with a metabolic mask (TrueOne 2400 Metabolic Cart, ParvoMedics, Sandy, Utah) and cycle for 30 min at 70% VO2 peak. After a 5 min active recovery period, self-paced pedaling against 50 W, participants will perform four 12 s maximal effort sprints against 5.5% of their body mass, followed by one 30 s maximal effort sprint against 5.5% of their body mass. Participants will perform 2.5 min active recovery (self-paced pedaling against 50 W) between sprints. Participants will then exit the chamber and be allowed to drink ad libitum in a resting position.
Experimental Trials This section provides an overview of the experimental trials, with greater detail provided in the appropriate sections below.
The experimental trials will occur after the first week of supplementation on day 7, and the second week of supplementation on day 21. The participants will be asked to ingest a CorTemp Sensor (HQInc, Palmetto, FL) 10-12 hr before arrival. Participants will be asked to arrive at the Sandels building in the morning in a euhydrated state, having consumed 6 ml·kg-1 water 60 minutes prior to arrival. Additionally, participants will be asked to arrive following an overnight fast (7-9 hr) having abstained from caffeine for the previous 12 hours, and having abstained from alcohol and exercise for the previous 24 hr. Participants will be asked to provide a urine sample to confirm hydration status. A urine specific gravity (USG) measurement of >1.020 will be considered dehydrated, whereas a USG measurement of <1.020 will be considered euhydrated 124-126. If the participant is considered dehydrated upon arrival, they will be provided with 6 mL·kg-1 water and the experimental trial will be pushed back another 30 minutes. Additionally, hydration status will be measured via changes in pre- to post-exercise body mass. Participants, in a private room, will be asked to towel dry and provide a nude body weight while resting pre-exercise, and again after the 60 min bout of exercise. Prior to exercise, participants will be asked to rest quietly in a supine position for 5 minutes, before blood pressure will be measured via auscultation and sphygmomanometry (Grainger, Lake Forest, Illinois). While still in a supine position, fluid compartments will be measured via bioelectric impedance spectroscopy (BIS) (ImpediMed SFB7, ImpediMed Limited, Australia).
Participants will then be fitted with iButtons (iButton DS1921G-F5, Maxim Integrated, San Jose, CA, USA) to estimate whole body skin temperature from 7 standardized locations on the body. Specifically, the investigators will use the abdomen (site A), inferior angle of the left scapula (site B), left posterior forearm (site C), dorsal side of the left hand (site D), left anterior thigh (site E), posterior side of the lower leg (site F), and left mid-foot (site G) 224. Then, participants will be seated in an upright position and fitted with a heart rate monitor (Polar® FT4M, Sempele, Finland) and metabolic mask (TrueOne 2400 Metabolic Cart, ParvoMedics, Sandy, Utah). Baseline measures of core temperature, skin temperature, heart rate, gas exchange, and blood will be sampled at this time.
Following baseline measurements, participants will enter the chamber (33° C, 35% RH) and complete a workload corresponding to 70% VO2 peak for 60 min. Immediately following the steady state exercise bout, participants will have a 5 min rest period to collect a blood sample and nude body weight. Afterwards, participants will perform four 12 s maximal effort sprints against 5.5% of their body mass, followed by one 30 s maximal effort sprint against 5.5% of their body mass. Participants will perform 2.5 min active recovery (self-paced pedaling against 50 W) between sprints. Participants will then exit the chamber and be allowed to drink ad libitum in a resting position.
Environmental Chamber Ambient Temperature Ambient temperature and humidity will be controlled via the environmental chamber and will be secondarily confirmed (Vantage Vue Weather Station, Davis Instruments, Hayward, California) in 10 min increments throughout experimental visits.
Standardization of Diet and Training Prior to each familiarization and experimental visit, participants will be asked to maintain consistent dietary and exercise habits for 2 days. Additionally, for both days leading up to experimental trials, participants will be asked to exactly replicate their dietary intake from week to week. To ensure compliance, participants will be asked to complete a 48-hr dietary intake form (Appendix C) and a 48-hr exercise log (Appendix D) for the days preceding the experimental trial. Finally, participants will be asked to abstain from caffeine for the previous 12 hours, and abstain from alcohol and exercise for the previous 24 hr.
- Conditions
- Healthy
- Being tested
- Betaine, BCAA Big 6, Placebo
- Keywords
- Betaine, NOW Foods BCAA Big 6, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetaineDietary supplement
Also called Trimethylglycine
50 mg/kg Betaine consumed twice daily for 7 days.
BCAA Big 6Dietary supplement
1 level scoop (~18 g) of NOW Foods BCAA Big 6, consumed once per day for 7 days.
PlaceboDietary supplement
50 mg/kg Placebo consumed twice daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Betaine; Dietary Supplement: BCAA Big 6; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid Compartment Volumes (Bioelectrical Impedance Spectrocopy)
Intracellular fluid volume (L), extracellular fluid volume (L), plasma volume (L), total body water (L)
Measured: pre and post 7 days of supplementation
Thermoregulation (core temperature pills, skin temperature sensors)
Core temperature (Degrees C), skin temperature (Degrees C)
Measured: 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
Measured: 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)
Measured: minutes 0, 15, 30, 45, 60, 75, and 90 during the experimental visit
Secondary outcomes (2)
Exercise Metabolism and Performance (heart rate)
heart rate (beats per minute)
Measured: minutes 0, 15, 30, 45, 60, 75, and 90 during the experimental visit
Exercise Metabolism and Performance (Oxygen Consumption)
volume of oxygen consumption (L), volume of carbon dioxide production (L)
Measured: minutes 0-5, 25-30, and 55-60 during the experimental visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start21 Jan 2020
- Primary completion15 Aug 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- NOW Foods
- Responsible party
- Principal investigator, Michael J. Ormsbee, Florida State University
- Investigators
- Miachael Ormsbee, PhD, Study director, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585295
- Sponsor's protocol ID
- Betaine
- Status last verified
- Mar 2024
- First submitted
- 8 Jul 2019
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pre-Loaded Betaine Supplementation on Thermoregulation and Exercise Metabolism in the Heat
- ClinicalTrials.gov ID
- NCT04585295
- Acronym / sponsor ID
- Betaine
- Conditions
- Healthy
- Keywords
- Betaine, NOW Foods BCAA Big 6, Placebo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- NOW Foods
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Initial Visit Participants will be asked to come into the ISSM in the morning, following an overnight fast (7-9 hr) having abstained from caffeine for the previous 12 hours, and having abstained from alcohol and exercise for the previous 24 hr. Participants will be asked to consume 6 ml·kg-1 water 60 minutes prior to arrival. Following the signing of the informed consent document, participants will be asked to change into athletic clothing. Thereafter, with shoes removed, participants' height will be assessed to the nearest cm via a wall-mounted scale (Seca, Hamburg, Germany). Participants will be weighed to the nearest 0.1 kg via an automated scale (Detecto® 750, Webb City, MO). Body composition will then be assessed via Bod Pod (Cosmed, Chicago, IL). Participants will be asked to rest quietly in a supine position for 5 minutes, before blood pressure will be measured via auscultation and sphygmomanometry (Grainger, Lake Forest, Illinois). While still in a supine position, fluid compartments will be measured via bioelectric impedance spectroscopy (BIS) (ImpediMed SFB7, ImpediMed Limited, Australia).
Following these baseline measurements, participants will be asked to wear a heart rate monitor then complete a self-determined 5-min warm-up on an electronically-braked cycle ergometer (Velotron, SRAM, Spearfish, SD). Immediately after the warm-up, participants will be fitted with a metabolic mask (TrueOne 2400 Metabolic Cart, ParvoMedics, Sandy, Utah) then commence an incremental exercise test to exhaustion. The incremental test will consist of 3-min stages in which the resistance will begin at a relative intensity of 2 W·kg-1 and increase in 25 W increments until RER is greater than 1.0. At this point, the test will switch to 1-min stages with resistance increasing in 10 W increments until volitional exhaustion. A similar protocol is described elsewhere 223.
Afterwards, participants will be provided with their blinded supplement and instructed to consume 50 mg·kg-1 twice daily (~12 hr apart) with 6 ml·kg-1 water each time, for 7 days.
Familiarization Trials The familiarization trials will occur the first week of supplementation on days 2 and 4, and the second week of supplementation on days 16 and 18. On familiarization days, participants will be asked to arrive at the Sandels building in the morning in a euhydrated state, having consumed 6 ml·kg-1 water 60 minutes prior to arrival. Additionally, participants will be asked to arrive following an overnight fast (7-9 hr) having abstained from caffeine for the previous 12 hours, and having abstained from alcohol and exercise for the previous 24 hr. Upon arrival, the participant will be fitted with a heart rate monitor (Polar® FT4M, Sempele, Finland). Participants will enter the chamber (33° C, 35% RH), be fitted with a metabolic mask (TrueOne 2400 Metabolic Cart, ParvoMedics, Sandy, Utah) and cycle for 30 min at 70% VO2 peak. After a 5 min active recovery period, self-paced pedaling against 50 W, participants will perform four 12 s maximal effort sprints against 5.5% of their body mass, followed by one 30 s maximal effort sprint against 5.5% of their body mass. Participants will perform 2.5 min active recovery (self-paced pedaling against 50 W) between sprints. Participants will then exit the chamber and be allowed to drink ad libitum in a resting position.
Experimental Trials This section provides an overview of the experimental trials, with greater detail provided in the appropriate sections below.
The experimental trials will occur after the first week of supplementation on day 7, and the second week of supplementation on day 21. The participants will be asked to ingest a CorTemp Sensor (HQInc, Palmetto, FL) 10-12 hr before arrival. Participants will be asked to arrive at the Sandels building in the morning in a euhydrated state, having consumed 6 ml·kg-1 water 60 minutes prior to arrival. Additionally, participants will be asked to arrive following an overnight fast (7-9 hr) having abstained from caffeine for the previous 12 hours, and having abstained from alcohol and exercise for the previous 24 hr. Participants will be asked to provide a urine sample to confirm hydration status. A urine specific gravity (USG) measurement of >1.020 will be considered dehydrated, whereas a USG measurement of <1.020 will be considered euhydrated 124-126. If the participant is considered dehydrated upon arrival, they will be provided with 6 mL·kg-1 water and the experimental trial will be pushed back another 30 minutes. Additionally, hydration status will be measured via changes in pre- to post-exercise body mass. Participants, in a private room, will be asked to towel dry and provide a nude body weight while resting pre-exercise, and again after the 60 min bout of exercise. Prior to exercise, participants will be asked to rest quietly in a supine position for 5 minutes, before blood pressure will be measured via auscultation and sphygmomanometry (Grainger, Lake Forest, Illinois). While still in a supine position, fluid compartments will be measured via bioelectric impedance spectroscopy (BIS) (ImpediMed SFB7, ImpediMed Limited, Australia).
Participants will then be fitted with iButtons (iButton DS1921G-F5, Maxim Integrated, San Jose, CA, USA) to estimate whole body skin temperature from 7 standardized locations on the body. Specifically, the investigators will use the abdomen (site A), inferior angle of the left scapula (site B), left posterior forearm (site C), dorsal side of the left hand (site D), left anterior thigh (site E), posterior side of the lower leg (site F), and left mid-foot (site G) 224. Then, participants will be seated in an upright position and fitted with a heart rate monitor (Polar® FT4M, Sempele, Finland) and metabolic mask (TrueOne 2400 Metabolic Cart, ParvoMedics, Sandy, Utah). Baseline measures of core temperature, skin temperature, heart rate, gas exchange, and blood will be sampled at this time.
Following baseline measurements, participants will enter the chamber (33° C, 35% RH) and complete a workload corresponding to 70% VO2 peak for 60 min. Immediately following the steady state exercise bout, participants will have a 5 min rest period to collect a blood sample and nude body weight. Afterwards, participants will perform four 12 s maximal effort sprints against 5.5% of their body mass, followed by one 30 s maximal effort sprint against 5.5% of their body mass. Participants will perform 2.5 min active recovery (self-paced pedaling against 50 W) between sprints. Participants will then exit the chamber and be allowed to drink ad libitum in a resting position.
Environmental Chamber Ambient Temperature Ambient temperature and humidity will be controlled via the environmental chamber and will be secondarily confirmed (Vantage Vue Weather Station, Davis Instruments, Hayward, California) in 10 min increments throughout experimental visits.
Standardization of Diet and Training Prior to each familiarization and experimental visit, participants will be asked to maintain consistent dietary and exercise habits for 2 days. Additionally, for both days leading up to experimental trials, participants will be asked to exactly replicate their dietary intake from week to week. To ensure compliance, participants will be asked to complete a 48-hr dietary intake form (Appendix C) and a 48-hr exercise log (Appendix D) for the days preceding the experimental trial. Finally, participants will be asked to abstain from caffeine for the previous 12 hours, and abstain from alcohol and exercise for the previous 24 hr.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Betaine | Experimental | Dietary Supplement: Betaine, Dietary Supplement: BCAA Big 6, Dietary Supplement: PlaceboAim 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. |
| Placebo | Experimental | Dietary Supplement: Betaine, Dietary Supplement: BCAA Big 6, Dietary Supplement: PlaceboAim 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. |
| NOW Foods Big 6 | Experimental | Dietary Supplement: Betaine, Dietary Supplement: BCAA Big 6, Dietary Supplement: PlaceboAim 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sex: male
- Age: 18-45 yr
- Trained male cyclists: ≥ 3 yr cycling experience
- Participants' VO2 peak > 50.0 ml·kg·min-1
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BetaineAlso: Trimethylglycine50 mg/kg Betaine consumed twice daily for 7 days. | Dietary supplement | Betaine, NOW Foods Big 6, Placebo |
| BCAA Big 61 level scoop (~18 g) of NOW Foods BCAA Big 6, consumed once per day for 7 days. | Dietary supplement | Betaine, NOW Foods Big 6, Placebo |
| Placebo50 mg/kg Placebo consumed twice daily for 7 days. | Dietary supplement | Betaine, NOW Foods Big 6, Placebo |
Primary outcome
Fluid Compartment Volumes (Bioelectrical Impedance Spectrocopy)
Time frame: pre and post 7 days of supplementation
Intracellular fluid volume (L), extracellular fluid volume (L), plasma volume (L), total body water (L)
Thermoregulation (core temperature pills, skin temperature sensors)
Time frame: pre and post 7 days of supplementation & minutes 0, 15, 30, 45, 60, 75, and 90 during the experimental visit
Core temperature (Degrees C), skin temperature (Degrees C)
Thermoregulation (enzyme linked immunoassays)
Time frame: 7 days of supplementation & minutes 0, 30, 60, and 90 during the experimental visit
serum expression of heat shock protein 72 and plasma lipopolysaccharide concentrations
Thermoregulation (thermal sensation scale)
Time frame: minutes 0, 15, 30, 45, 60, 75, and 90 during the experimental visit
Subjective self-reported assessment of perceived thermal sensation (arbitrary units)
2 secondary outcomes
Exercise Metabolism and Performance (heart rate)
Time frame: minutes 0, 15, 30, 45, 60, 75, and 90 during the experimental visit
Exercise Metabolism and Performance (Oxygen Consumption)
Time frame: minutes 0-5, 25-30, and 55-60 during the experimental visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miachael Ormsbee, PhD study director
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betaine and BCAA Big 6 in people with Healthy, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid Compartment Volumes (Bioelectrical Impedance Spectrocopy) (time frame: pre and post 7 days of supplementation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.