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Antioxidant Supplementation + Heat Exercise for Heat Stress Disorders (ATHENA Trial)

N/A

Recruiting

Led By Douglas J Casa, PhD

Research Sponsored by University of Connecticut

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measurement completed during each exercise-heat stress bout (heat tolerance tests 1 [days 5 and 12] and 2 [days 6 and 13]) both before and immediately after heat acclimation as well as the final heat acclimation session (ha5 - day 11)

Awards & highlights

ATHENA Trial Summary

This trial seeks to compare the impact of heat and exercise on men and women to better understand and prevent injury and illnesses.

Who is the study for?

This trial is for healthy men and women, aged 18-50, with good aerobic fitness (VO2max ≥45 ml·kg-1·min-1 for males, ≥40 ml·kg-1·min-1 for females), who can understand English. It's not suitable for those with heat stress issues, blood draw or biopsy contraindications, on certain diets like fasting or veganism, pregnant women, people unable to commit to the schedule, hypertensive individuals or those with recent illness including COVID.Check my eligibility

What is being tested?

The study investigates how men and women respond differently to intense exercise in hot conditions by looking at various tissues' responses. Participants will undergo a heat acclimation protocol followed by acute exercise tests. Some will also take an antioxidant berry supplement or placebo to see if it improves performance.See study design

What are the potential side effects?

Potential side effects may include discomfort from heat exposure during exercises and reactions related to the antioxidant supplementation such as allergies. The procedures might cause temporary soreness where blood draws or biopsies are taken.

ATHENA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measurement completed during each exercise-heat stress bout (heat tolerance tests 1 [days 5 and 12] and 2 [days 6 and 13]) both before and immediately after heat acclimation as well as the final heat acclimation session (ha5 - day 11)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measurement completed during each exercise-heat stress bout (heat tolerance tests 1 [days 5 and 12] and 2 [days 6 and 13]) both before and immediately after heat acclimation as well as the final heat acclimation session (ha5 - day 11)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measurement completed during each exercise-heat stress bout (heat tolerance tests 1 [days 5 and 12] and 2 [days 6 and 13]) both before and immediately after heat acclimation as well as the final heat acclimation session (ha5 - day 11) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Circulatory Indicators of Inflammation - IFN-gamma

Change in Circulatory Indicators of Inflammation - IL-1B

Change in Circulatory Indicators of Inflammation - TNF-a

+38 more

Secondary outcome measures

Change in Body Mass

Change in Cardiovascular Response - Blood Pressure

Change in Environmental Perception

+9 more

ATHENA Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Acute and Chronic Exercise-Heat StressExperimental Treatment1 Intervention

All participants (male and female) will be exposed to repeated bouts of exercise-heat stress.

Group II: Exercise-Heat Stress + Antioxidant Berry SupplementationActive Control2 Interventions

All participants (male and female) will be exposed to repeated bouts of exercise-heat stress. Participants who opt-in may be randomly assigned to receive bioactive (antioxidant berry supplement) ingredient in addition to repeated bouts of exercise-heat stress.

Group III: Exercise-Heat Stress + Placebo (Non-juice) SupplementationPlacebo Group2 Interventions

All participants (male and female) will be exposed to repeated bouts of exercise-heat stress. Participants who opt-in may be randomly assigned to receive placebo (non-juice) ingredient in addition to repeated bouts of exercise-heat stress.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ConnecticutLead Sponsor

183 Previous Clinical Trials

158,113 Total Patients Enrolled

1 Trials studying Heat Stress

18 Patients Enrolled for Heat Stress

United States Department of DefenseFED

863 Previous Clinical Trials

227,572 Total Patients Enrolled

1 Trials studying Heat Stress

18 Patients Enrolled for Heat Stress

Douglas J Casa, PhDPrincipal InvestigatorKorey Stringer Institute - UConn

3 Previous Clinical Trials

72 Total Patients Enrolled

1 Trials studying Heat Stress

18 Patients Enrolled for Heat Stress

Media Library

Acute and Chronic Exercise-Heat Stress Clinical Trial Eligibility Overview. Trial Name: NCT05678738 — N/A

Heat Stress Research Study Groups: Acute and Chronic Exercise-Heat Stress, Exercise-Heat Stress + Antioxidant Berry Supplementation, Exercise-Heat Stress + Placebo (Non-juice) Supplementation

Heat Stress Clinical Trial 2023: Acute and Chronic Exercise-Heat Stress Highlights & Side Effects. Trial Name: NCT05678738 — N/A

Acute and Chronic Exercise-Heat Stress 2023 Treatment Timeline for Medical Study. Trial Name: NCT05678738 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings remaining for participation in this clinical research?

"Evidently, this medical experiment is currently enrolling participants. The trial was first published on September 16th 2021 and the information has been updated most recently on December 28th 2022."

Answered by AI

Are elders of a certain age eligible to join the experiment?

"According to the study's inclusivity parameters, applicants must be between 18 and 50 years old. Additionally, there are 12 studies for younger individuals and 167 experiments targeting those over 65."

Answered by AI

What aim does this research endeavor to fulfill?

"The primary objective in this trial, which will take an average of 14 days to complete, is to assess the change in rectal temperature rate of rise. Secondary endpoints measure alterations in thirst level on a 0-9 scale (where higher scores signify more intense levels of thirst), environmental perception using the modified Environmental Symptoms Questionnaire (ESQ) and rating of perceived exertion with a 6-20 point range where larger numbers denote greater effort expended."

Answered by AI

Is there an opportunity for me to join the experiment?

"This study is recruiting 60 healthy male and female participants between 18-50 years old who are proficient in English. Qualifying subjects must demonstrate a minimum VO2max of 45 ml·kg-1·min-1 for males, 40 ml·kg-1·min-1 for females, have no vision or auditory impairments, and possess the capability to operate a computer keyboard and mouse as well as read from a screen."

Answered by AI

To what extent has recruitment for this clinical trial been successful?

"Affirmative. The clinicaltrials.gov database indicates that this medical study, which was initiated on September 16th 2021, is actively seeking volunteers to enroll. Around 60 people are needed from one trial site for the experiment to continue."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Acquiring and Targeting Heat Exposures Necessary for Action

Douglas J Casa 2021. "Acquiring and Targeting Heat Exposures Necessary for Action". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05678738.