TerminatedNot Applicable

Effects of Exercise & Tart Cherry Ingestion on Heat Acclimation and Gut Microbiome

Stopped: Low enrollment of participants

United States4 participantsStarted 2022-01-26

Plain-language 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. 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.

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male * 18-55 years old * Recreational cyclists (\>150 minutes per week of cycling exercise) * VO2max \>60th percentile according to ACSM Exclusion Criteria: * 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 * 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

What they're measuring

Change in Plasma TNF-a

Timeframe: pre, 1 hour post heat tolerance test

Change in Plasma IL-6

Timeframe: pre, 1 hour post heat tolerance test

Change in Plasma HSP70

Timeframe: pre, 1 hour post heat tolerance test

Change in Plasma melatonin content

Timeframe: 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

Timeframe: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)

Change in Skin temperature response to heat tolerance test

Timeframe: 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

Timeframe: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)

Trial details

NCT IDNCT05281198

SponsorOhio University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-30

View on ClinicalTrials.gov More Heat Acclimation and Thermotolerance trials

Plain-language summary

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Plasma TNF-a

Timeframe: pre, 1 hour post heat tolerance test

Change in Plasma IL-6

Timeframe: pre, 1 hour post heat tolerance test

Change in Plasma HSP70

Timeframe: pre, 1 hour post heat tolerance test

Change in Plasma melatonin content

Timeframe: 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

Timeframe: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)

Change in Skin temperature response to heat tolerance test

Timeframe: 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

Timeframe: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)