Heat Acclimation and ThermotoleranceNCT05281198
Effects of Exercise & Tart Cherry Ingestion on Heat Acclimation and Gut Microbiome
A study testing tart cherry juice in people with Heat Acclimation and Thermotolerance, run by Ohio University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether tart cherry supplementation effects thermotolerance and heat acclimation in human subjects exposed to exercise/heat stress. Specific Aim I. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heat Acclimation and Thermotolerance
- What is being tested?
- tart cherry juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2022to 30 Apr 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- 18-55 years old
- Recreational cyclists (>150 minutes per week of cycling exercise)
- VO2max >60th percentile according to ACSM
Who cannot join
- Previous episode of heat illness, such as heat syncope, heat exhaustion or heat stroke
- Known cardiopulmonary disease, metabolic disorders, Parkinsons Disease, or multiple sclerosis or other autonomic nervous system conditions
- diagnosed with or being treated for arthritis or any inflammatory condition (such as Lupus, gout, or Sjogrens syndrome)
- Known or suspected orthostatic hypotension or low blood pressure
- Known issues with cooling or sweating
- currently smoke or quit smoking less than one year ago
Show all 10Show fewer
- not willing to self-insert a flexible, thin (3 mm) vinyl rectal probe and maintain this position throughout all exercise sessions.
- not willing to have blood drawn pre-supplementation and 4 times during heat stress test trials (a total of 10 times during the study).
- not willing to provide a stool sample pre- and post-heat stress tests (4 total samples).
- allergy to cherries or food dyes
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio University Exercise Physiology Lab
Athens, Ohio, 45701
About this study
The purpose of this study is to determine whether tart cherry supplementation effects thermotolerance and heat acclimation in human subjects exposed to exercise/heat stress.
Specific Aim I. To determine if tart cherry in combination with repeated bouts of thermally stressful exercise will impact the gut microbiome \& inflammation measured via stool sample \& blood samples for plasma endotoxin, inflammatory cytokines and HSP.
Read more
Specific Aim II. To determine whether whole body hyperthermia causes changes in bacterial populations in the gut microbiome, and if these changes are affected by washout or re-acclimation.
Specific Aim III. To determine whether tart cherry supplementation suppresses the ability of human subjects to acclimate to exercise/heat stress. This will be assessed via body temperature, heart rate, sweat and plasma volume responses, and exercise performance during standardized heat tolerance tests.
Read the detailed description
10 recreationally trained cyclists will be recruited and will complete the study in counter-balanced randomized order (5 will start with placebo and 5 will start with tart cherry juice, then have a 4 week washout and complete the other intervention). Participants will complete 15 total sessions in the exercise physiology lab including: a VO2max test, 4 heat stress tests (pre- and post-acclimation) and 5 consecutive days of heat acclimation sessions (twice).
The VO2max test will be an incremental cycling test, starting at 80 Watts and increasing 25 Watts per minute until fatigue. The maximal Wattage will be used to determine exercise intensity during the heat stress test and heat acclimation sessions.
The heat stress test and heat acclimation sessions will occur in a controlled environment of 38C and 25% humidity. Airflow will be provided with a fan at 1 m/s. Prior to entering the controlled environment, participants will provide a mid-stream urine sample to assess hydration status via urine specific gravity (USG) and osmolality (Vapro, ELITech), then empty their bladder, measure their nude body mass on a scale (in a private bathroom in the lab), and self-insert a rectal thermometer 10cm past the anal sphincter. If the participant is dehydrated, they will be instructed to drink 500 ml of water and wait to start exercise until their hydration level is normal (USG<1.020, urine osmolality 500 800 mOsm). Researchers will then affix skin temperature sensors to the participants chest, arm, thigh, and calf and a heart rate monitor to their chest. Participants will the enter the heat chamber and sit on the bicycle for 5 minutes to get acclimated to the environment and to obtain resting levels of thermal sensation and perceived effort. Following these 5 minutes, the participant will commence exercise (described below). Participants will be provided water kept in the controlled environment (to avoid cooling) to consume ad libitum throughout all exercise sessions. Following the exercise session, participants will exit the controlled environment and void their bladder, collecting all urine in a cylinder and towel dry and assess their nude body mass. These will be used along with volume of water consumed during exercise to assess body mass changes and sweat rate.
Heat stress test:
The heat stress test will consist of cycling at 40% of their maximal Watt output for 45 minutes, followed by a 5k time trial, where they will cover the 5k in as fast a time as possible.
Heat acclimation sessions Heat acclimation sessions will be 60 minutes and will utilize an isothermic heat acclimation modality where individuals will exercise at a self-selected cadence to reach a core temperature of 38.5C. Once 38.5C has been reached, they will stop exercising and rest. Typical time to reach a core body temperature of 38.5C is 30-50 minutes, so the individual will exercise for this time, and rest for the remainder of the 60 minutes. During this rest time, body temperature will continue to rise because of metabolic heat and heat produced from exercises. However if their temperature reduces below 38.5C, they will begin exercise again to maintain temperature above 38.5C. These sessions will occur daily for 5 days.
Supplementation Participants will begin supplementation 24 hours prior to their first heat stress test and throughout their heat acclimation sessions until the final heat stress test has been completed (7 days of supplementation total). Supplementation will consist of consuming an 8 oz bottle of tart cherry juice or placebo twice daily, once in the morning and once in the evening, at least 2 hours before bed. Following a 4 week washout period, participants will complete the opposite condition (placebo or polyphenol).
The investigators will assess the impact of hyperthermia on the gut microbiome before and after heat acclimation. Participants will provide a stool sample at pre-supplementation and 24 hours post each of the heat stress tests (pre- and post-acclimation) for each of the interventions (tart cherry and placebo). Participants will collect a stool sample using a toilet hat and aliquot three small samples. They will be provided with a toilet hat, a pair of gloves, a sterile spatula, and three sterile eppendorf tubes. They will be asked to put approximately a nickle sized sample in each of these tubes. These will be placed in the freezer and brought to the lab on ice (they will be provided with a biohazard cooler bag and ice pack for transport), where they will be stored at -80C until analysis.
- Conditions
- Heat Acclimation and Thermotolerance
- Being tested
- tart cherry juice, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tart cherry juiceDietary supplement
2, 8oz bottles of Montmorency tart cherry juice daily; 8oz taken in AM, 8oz taken in PM
PlaceboDietary supplement
2, 8oz bottles of placebo juice daily; 8oz taken in AM, 8oz taken in PM
| Study group | Role | What they receive |
|---|---|---|
| Experimental: tart cherry | Experimental | dietary supplement: tart cherry juice Receives: Dietary Supplement: tart cherry juice |
| Placebo | Placebo comparator | dietary supplement: placebo juice Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma TNF-a
Plasma TNF-a changes from pre to 1 hour post heat tolerance test
Measured: pre, 1 hour post heat tolerance test
Change in Plasma IL-6
Plasma IL-6 changes from pre to 1 hour post heat tolerance test
Measured: pre, 1 hour post heat tolerance test
Change in Plasma HSP70
Plasma HSP70 changes from pre to 1 hour post heat tolerance test
Measured: pre, 1 hour post heat tolerance test
Change in Plasma melatonin content
Plasma melatonin content from pre to post supplementation
Measured: pre- heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)
Change in Core temperature response to heat tolerance test
Core temperature response to heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress
Measured: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)
Change in Skin temperature response to heat tolerance test
Skin temperature response to heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress
Measured: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)
Change in Mean body temperature response to heat tolerance test
Mean body temperature response to heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress
Measured: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)
Change in Heart rate response to heat tolerance test
Heart rate response to heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress
Measured: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)
Change in Physiological strain response to heat tolerance test
Physiological strain response to heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress
Measured: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)
Change in gut microbial content
Gut microbial content from pre to post supplementation
Measured: pre- heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start26 Jan 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Why it stopped: Low enrollment of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat Acclimation and ThermotoleranceStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Hillman, PhD, Principal investigator, Division of Exercise Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281198
- Sponsor's protocol ID
- 21-F-33
- Status last verified
- Oct 2023
- First submitted
- 14 Feb 2022
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise & Tart Cherry Ingestion on Heat Acclimation and Gut Microbiome
- ClinicalTrials.gov ID
- NCT05281198
- Acronym / sponsor ID
- 21-F-33
- Conditions
- Heat Acclimation and Thermotolerance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment of participants
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 16 Mar 2022 (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.
The purpose of this study is to determine whether tart cherry supplementation effects thermotolerance and heat acclimation in human subjects exposed to exercise/heat stress.
Specific Aim I. To determine if tart cherry in combination with repeated bouts of thermally stressful exercise will impact the gut microbiome \& inflammation measured via stool sample \& blood samples for plasma endotoxin, inflammatory cytokines and HSP.
Specific Aim II. To determine whether whole body hyperthermia causes changes in bacterial populations in the gut microbiome, and if these changes are affected by washout or re-acclimation.
Specific Aim III. To determine whether tart cherry supplementation suppresses the ability of human subjects to acclimate to exercise/heat stress. This will be assessed via body temperature, heart rate, sweat and plasma volume responses, and exercise performance during standardized heat tolerance tests.
Detailed description
10 recreationally trained cyclists will be recruited and will complete the study in counter-balanced randomized order (5 will start with placebo and 5 will start with tart cherry juice, then have a 4 week washout and complete the other intervention). Participants will complete 15 total sessions in the exercise physiology lab including: a VO2max test, 4 heat stress tests (pre- and post-acclimation) and 5 consecutive days of heat acclimation sessions (twice).
The VO2max test will be an incremental cycling test, starting at 80 Watts and increasing 25 Watts per minute until fatigue. The maximal Wattage will be used to determine exercise intensity during the heat stress test and heat acclimation sessions.
The heat stress test and heat acclimation sessions will occur in a controlled environment of 38C and 25% humidity. Airflow will be provided with a fan at 1 m/s. Prior to entering the controlled environment, participants will provide a mid-stream urine sample to assess hydration status via urine specific gravity (USG) and osmolality (Vapro, ELITech), then empty their bladder, measure their nude body mass on a scale (in a private bathroom in the lab), and self-insert a rectal thermometer 10cm past the anal sphincter. If the participant is dehydrated, they will be instructed to drink 500 ml of water and wait to start exercise until their hydration level is normal (USG<1.020, urine osmolality 500 800 mOsm). Researchers will then affix skin temperature sensors to the participants chest, arm, thigh, and calf and a heart rate monitor to their chest. Participants will the enter the heat chamber and sit on the bicycle for 5 minutes to get acclimated to the environment and to obtain resting levels of thermal sensation and perceived effort. Following these 5 minutes, the participant will commence exercise (described below). Participants will be provided water kept in the controlled environment (to avoid cooling) to consume ad libitum throughout all exercise sessions. Following the exercise session, participants will exit the controlled environment and void their bladder, collecting all urine in a cylinder and towel dry and assess their nude body mass. These will be used along with volume of water consumed during exercise to assess body mass changes and sweat rate.
Heat stress test:
The heat stress test will consist of cycling at 40% of their maximal Watt output for 45 minutes, followed by a 5k time trial, where they will cover the 5k in as fast a time as possible.
Heat acclimation sessions Heat acclimation sessions will be 60 minutes and will utilize an isothermic heat acclimation modality where individuals will exercise at a self-selected cadence to reach a core temperature of 38.5C. Once 38.5C has been reached, they will stop exercising and rest. Typical time to reach a core body temperature of 38.5C is 30-50 minutes, so the individual will exercise for this time, and rest for the remainder of the 60 minutes. During this rest time, body temperature will continue to rise because of metabolic heat and heat produced from exercises. However if their temperature reduces below 38.5C, they will begin exercise again to maintain temperature above 38.5C. These sessions will occur daily for 5 days.
Supplementation Participants will begin supplementation 24 hours prior to their first heat stress test and throughout their heat acclimation sessions until the final heat stress test has been completed (7 days of supplementation total). Supplementation will consist of consuming an 8 oz bottle of tart cherry juice or placebo twice daily, once in the morning and once in the evening, at least 2 hours before bed. Following a 4 week washout period, participants will complete the opposite condition (placebo or polyphenol).
The investigators will assess the impact of hyperthermia on the gut microbiome before and after heat acclimation. Participants will provide a stool sample at pre-supplementation and 24 hours post each of the heat stress tests (pre- and post-acclimation) for each of the interventions (tart cherry and placebo). Participants will collect a stool sample using a toilet hat and aliquot three small samples. They will be provided with a toilet hat, a pair of gloves, a sterile spatula, and three sterile eppendorf tubes. They will be asked to put approximately a nickle sized sample in each of these tubes. These will be placed in the freezer and brought to the lab on ice (they will be provided with a biohazard cooler bag and ice pack for transport), where they will be stored at -80C until analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: tart cherry | Experimental | Dietary Supplement: tart cherry juicedietary supplement: tart cherry juice |
| Placebo | Placebo comparator | Dietary Supplement: Placebodietary supplement: placebo juice |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- 18-55 years old
- Recreational cyclists (>150 minutes per week of cycling exercise)
- VO2max >60th percentile according to ACSM
Key exclusion criteria (10 listed)
- Previous episode of heat illness, such as heat syncope, heat exhaustion or heat stroke
- Known cardiopulmonary disease, metabolic disorders, Parkinsons Disease, or multiple sclerosis or other autonomic nervous system conditions
- diagnosed with or being treated for arthritis or any inflammatory condition (such as Lupus, gout, or Sjogrens syndrome)
- Known or suspected orthostatic hypotension or low blood pressure
- Known issues with cooling or sweating
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 |
|---|---|---|
| tart cherry juice2, 8oz bottles of Montmorency tart cherry juice daily; 8oz taken in AM, 8oz taken in PM | Dietary supplement | Experimental: tart cherry |
| Placebo2, 8oz bottles of placebo juice daily; 8oz taken in AM, 8oz taken in PM | Dietary supplement | Placebo |
Primary outcome
Change in Plasma TNF-a
Time frame: pre, 1 hour post heat tolerance test
Plasma TNF-a changes from pre to 1 hour post heat tolerance test
Change in Plasma IL-6
Time frame: pre, 1 hour post heat tolerance test
Plasma IL-6 changes from pre to 1 hour post heat tolerance test
Change in Plasma HSP70
Time frame: pre, 1 hour post heat tolerance test
Plasma HSP70 changes from pre to 1 hour post heat tolerance test
Change in Plasma melatonin content
Time frame: pre- heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)
Plasma melatonin content from pre to post supplementation
Change in Core temperature response to heat tolerance test
Time frame: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)
Core temperature response to heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress
Change in Skin temperature response to heat tolerance test
Time frame: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)
Skin temperature response to heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress
Change in Mean body temperature response to heat tolerance test
Time frame: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)
Mean body temperature response to heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress
Change in Heart rate response to heat tolerance test
Time frame: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)
Heart rate response to heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress
Change in Physiological strain response to heat tolerance test
Time frame: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)
Physiological strain response to heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress
Change in gut microbial content
Time frame: pre- heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)
Gut microbial content from pre to post supplementation
Results and safety
The study was stopped early (reason given: Low enrollment of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
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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.
Angela Hillman, PhD principal investigator
Division of Exercise Physiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tart cherry juice in people with Heat Acclimation and Thermotolerance, run by Ohio 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 10 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: stopped early, as of the sponsor's last update on 16 Oct 2023. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Low enrollment of participants). Results are not available in the source record.
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?
Change in Plasma TNF-a (time frame: pre, 1 hour post heat tolerance test). The study lists 10 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 16 Oct 2023.