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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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

Other trials in United States

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.

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 groups in NCT05281198
Study groupRoleWhat they receive
Experimental: tart cherryExperimentaldietary supplement: tart cherry juice
Receives: Dietary Supplement: tart cherry juice
PlaceboPlacebo comparatordietary supplement: placebo juice
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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

  3. Change in Plasma HSP70

    Plasma HSP70 changes from pre to 1 hour post heat tolerance test

    Measured: pre, 1 hour post heat tolerance test

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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.

  1. First posted16 Mar 2022
  2. Study start26 Jan 2022
  3. Primary completion30 Apr 2023
  4. Study completion30 Apr 2023

Why it stopped: Low enrollment of participants

Resources

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)
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

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.

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