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

NCT05281198 | Terminated

• 1 other identifier: 21-F-33
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heat Acclimation and Thermotolerance

Outcome Measures

Primary Outcomes (10)

• Change in Plasma TNF-a

  Plasma TNF-a changes from pre to 1 hour post heat tolerance test

  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

  pre, 1 hour post heat tolerance test

• Change in Plasma HSP70

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

  pre, 1 hour post heat tolerance test

• Change in Plasma melatonin content

  Plasma melatonin content from pre to post supplementation

  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

  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

  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

  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

  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

  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

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

Study Arms (2)

Experimental: tart cherry

EXPERIMENTAL

dietary supplement: tart cherry juice

Dietary Supplement: tart cherry juice

Placebo

PLACEBO COMPARATOR

dietary supplement: placebo juice

Dietary Supplement: Placebo

Interventions

tart cherry juice DIETARY_SUPPLEMENT

2, 8oz bottles of Montmorency tart cherry juice daily; 8oz taken in AM, 8oz taken in PM

Experimental: tart cherry

Placebo DIETARY_SUPPLEMENT

2, 8oz bottles of placebo juice daily; 8oz taken in AM, 8oz taken in PM

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• years old
• Recreational cyclists (\>150 minutes per week of cycling exercise)
• VO2max \>60th percentile according to ACSM

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio University: lead

Study Sites (1)

Ohio University Exercise Physiology Lab

Athens, Ohio, 45701, United States

Location

Study Officials

• Angela Hillman, PhD

  Division of Exercise Physiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 16, 2022
• Study Start: January 26, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

US (1)