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Acquiring and Targeting Heat Exposures Necessary for Action (ATHENA)

Primary Purpose

Heat Intolerance, Heat Stress, Fatigue; Heat

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Antioxidant Berry Supplementation
Acute and Chronic Exercise-Heat Stress
Placebo (non-juice) Supplementation
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Heat Intolerance focused on measuring Sex Differences, Physical Performance, Body Composition, Heat Acclimation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participants will be healthy men and women, aged 18-50 years, who speak and read the English language fluently. This is required because some of the cognitive tests test grammatical reasoning and offer directional cues recorded as audio files in English. VO2max tests will provide evidence of level of aerobic fitness required to participate in this study. The investigators will use ≥45 ml·kg-1·min-1 for male participants, ≥40 ml·kg-1·min-1 for female participants as our threshold for inclusion. The target composition of our subject sample is 50% men and 50% women. No difficulties with vision, hearing, or ability to read a computer screen and operate a computer keyboard and mouse. Exclusion Criteria: unable to visit the laboratory on the required, consistent schedule and consecutive required days (Days 2 and 3, Days 12 and 13) any contraindications to participating in exercise lasting 60-120 minutes daily during a period of 2 consecutive days, 5 days within an 8-day period, and 2 additional days (if subjects elect to participate in the entire study, all options), screening will include resting blood pressure to exclude pre-hypertensive or hypertensive participants (resting BP > 120 mmHg and 80mmHg systolic and diastolic, respectively) any contraindications to exposure to exercise-heat stress (e.g., medications that affect thermoregulation, family or personal history of issues with anesthetics that indicate possible susceptibility to malignant hyperthermia, evidence of past heat intolerance) tobacco use or electronic cigarettes (e-cigarettes) within the past 6 months chronic illness (including diabetes, metabolic syndrome, thyroid disease, for example) or other chronic illnesses that make it unsafe for participants to participate in daily rigorous exercise in the heat regular supplementation with blood thinners, including the use of aspirin acute illness (e.g., influenza, head cold, gastrointestinal illness) during the week of scheduled testing current positive COVID-test or infection and past COVID infection within past 6 months contraindications to blood draw and if elected to be considered for participation with microdialysis and skeletal muscle biopsy procedures, contraindications to those individual procedures for subjects who may not complete a DXA scan, history of claustrophobia history of allergic reactions to medical tape and/or latex currently participating in "non-traditional" diets including diets such as intermittent fasting, caloric restriction, highly limited consumption of large food classes (e.g., vegan) consumption of antioxidant supplementation on a regular, long-term basis outside of the aronia supplementation regime for the study limited decision-making ability inability to participate in extended physical activity on a treadmill (i.e., standing, running, jogging, walking) consumption of a non-traditional diet including diets such as intermittent fasting, caloric restriction, highly limited consumption of large food classes (e.g., vegan) (this includes individuals who are suffering with current diagnosed or undiagnosed eating disorder) allergy to povidone, ethyl chloride, lidocaine, or bacitracin pregnant or positive pregnancy test during DXA pre-procedures (see DXA SOP) allergy to aronia berries, monkfruit, or sham juice ingredients

Sites / Locations

  • Human Performance Laboratory at the University of ConnecticutRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Acute and Chronic Exercise-Heat Stress

Exercise-Heat Stress + Antioxidant Berry Supplementation

Exercise-Heat Stress + Placebo (Non-juice) Supplementation

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Change in Rectal Temperature at Rest
Rectal thermometer will be self-inserted by participants to assess core temperature prior to exercise-heat stress bouts
Change in Rectal Temperature Rate of Rise
Rectal thermometer will be self-inserted by participants to assess core temperature during exercise-heat stress bouts
Change in Rectal Temperature at Thermal Threshold (38.5C)
Rectal thermometer will be self-inserted by participants to assess core temperature during exercise-heat stress bouts at the thermal threshold of 38.5C
Change in Mean Skin Temperature
Prior to start of exercise, participants will be instrumented with iButton skin temperature sensors on the chest, shoulder, abdomen, neck, back, thigh, and calf
Change in Heart Rate
A heart rate monitor will be worn by participants throughout the exercise-heat stress bouts
Change in Heart Rate at Thermal Threshold (38.5C)
A heart rate monitor will be worn by participants throughout the exercise-heat stress bouts to assess HR at the thermal threshold of 38.5C
Change in Whole Body Sweat Rate
Difference in body weight measurement measured prior to and at the cessation of each exercise-heat stress bout
Change in Sweat Metabolite and Protein Expression
Sweat samples will be collected and assessed for metabolite and protein expression discovery via mass spectrometry
Change in Cognitive Measures - Visual Vigilance
Participants will perform an assessment of visual vigilance through a validated computer programming system. The test is part of a larger Testing battery which should take approximately 30 minutes for completion
Change in Cognitive Measures - Psychomotor Vigilance
Participants will perform an assessment of psychomotor vigilance through a validated computer programming system. The test is part of a larger Testing battery which should take approximately 30 minutes for completion
Change in Cognitive Measures - Four Choice Task
Participants will perform an assessment of four choice task success through a validated computer programming system. The test is part of a larger Testing battery which should take approximately 30 minutes for completion
Change in Cognitive Measures - Match to Sample
Participants will perform an assessment of match to sample success through a validated computer programming system. The test is part of a larger Testing battery which should take approximately 30 minutes for completion
Change in Cognitive Measures - Repeated Acquisition
Participants will perform an assessment of repeated acquisition through a validated computer programming system. The test is part of a larger Testing battery which should take approximately 30 minutes for completion
Change in Cognitive Measures - Grammatical Reasoning
Participants will perform an assessment of grammatical reasoning through a validated computer programming system. The test is part of a larger Testing battery which should take approximately 30 minutes for completion
Change in Cognitive Measures - Profile of Mood States
Participants will perform an assessment of profile of mood states through a validated computer programming system. The test is part of a larger Testing battery which should take approximately 30 minutes for completion
Change in Cognitive Measures - Stroop Task
Participants will perform an assessment of stroop task success through a validated computer programming system. The test is part of a larger Testing battery which should take approximately 30 minutes for completion
Change in Physical Performance - Anaerobic Performance
Participants will be assessed for anaerobic performance with the completion of a 400 meter sprint for time. This test is part of a larger physical performance battery test which should take approximately 30 minutes for completion
Change in Physical Performance - Agility Performance
Participants will be assessed for anaerobic performance with the completion of a quick feet agility test. This test is part of a larger physical performance battery test which should take approximately 30 minutes for completion
Change in Physical Performance - Upper Body Strength Performance
Participants will be assessed for upper body strength performance with the completion of a handgrip strength test. This test is part of a larger physical performance battery test which should take approximately 30 minutes for completion
Change in Physical Performance - Lower Body Power Performance
Participants will be assessed for lower body power performance with the completion of a vertical jump test. This test is part of a larger physical performance battery test which should take approximately 30 minutes for completion
Change in Physical Performance - Lower Body Kinematic Performance
Participants will be assessed for lower body kinematic performance with the completion of the Landing Error Scoring System (LESS) Test. This test is part of a larger physical performance battery test which should take approximately 30 minutes for completion
Change in Physical Performance - Balance Performance
Participants will be assessed for balance performance with the completion of the Balance Error Scoring System (BESS) Test. This test is part of a larger physical performance battery test which should take approximately 30 minutes for completion
Change in Musculoskeletal Gene and Protein Expression
Musculoskeletal tissue samples will be collected for analysis via RNA-seq
Change in Musculoskeletal Fiber-Typing
Musculoskeletal tissue samples will be collected for fiber-type analysis via immunohistochemical procedures
Change in Musculoskeletal Mitochondrial Function
Musculoskeletal tissue samples will be collected for analysis of mitochondrial function
Change in Subcutaneous Abdominal Tissue (SCAAT) Lipolysis Rate
SCAAT lipolysis rate (interstitial glycerol and ethanol output:input) will be collected and assessed for fat mobilization and subcutaneous adipose tissue blood flow during exercise-heat stress bouts
Change in Resting Energy Expenditure and Macronutrient Oxidation
Participant resting energy expenditure, fat oxidation, and carbohydrate oxidation will be assessed via indirect calorimetry for the measurement of respiratory quotient and respiratory exchange ratio
Change in Circulatory Indicators of Lipid Metabolism - NEFAs
Blood samples will be collected and assessed for the expression of lipid metabolism biomarker Non-Essential Fatty Acids (NEFAs)
Change in Circulatory Indicators of Lipid Metabolism - Insulin
Blood samples will be collected and assessed for the expression of lipid metabolism biomarker Insulin
Change in Circulatory Indicators of Lipid Metabolism - IGF-1
Blood samples will be collected and assessed for the expression of lipid metabolism biomarker Insulin Growth Factor-1 (IGF-1)
Change in Circulatory Indicators of Stress - Epinephrine
Blood samples will be collected and assessed for the expression of physiological stress biomarker Epinephrine
Change in Circulatory Indicators of Stress - Norepinephrine
Blood samples will be collected and assessed for the expression of physiological stress biomarker Norepinephrine
Change in Circulatory Indicators of Stress - Cortisol
Blood samples will be collected and assessed for the expression of physiological stress biomarker Cortisol
Change in Circulatory RNA Content
Blood samples will be collected and assessed for intracellular RNA content
Change in Circulatory Indicators of Inflammation - IL-1B
Blood samples will be collected and assessed for the expression of inflammatory biomarker IL-1B
Change in Circulatory Indicators of Inflammation - TNF-a
Blood samples will be collected and assessed for the expression of inflammatory biomarker TNF-a
Change in Circulatory Indicators of Inflammation - IFN-gamma
Blood samples will be collected and assessed for the expression of inflammatory biomarker IFN-gamma
Change in Gut Microbiome Diversity
Stool samples will be collected and assessed for the impact of gut microbiome diversity on heat intolerance
Change in Saliva Metabolite Expression
Saliva samples will be collected and assessed for metabolite expression
Change in Thermal Sensation
0-8 Scale (cold to hot) that indicated how cold or hot the participant feels. 0 = extremely cold, 8 = extremely hot
Change in Recovery
Participants will be provided a WHOOP strap after the completion of their baseline visit and will be instructed on how to download the associated application and use of the device. The WHOOP device will be used to provide data on sleep quality and quantity, strain, and recovery

Secondary Outcome Measures

Change in Perception of Fatigue
0-10 (no fatigue to extreme fatigue), scale indicates how fatigued the participant feels. High score indicates more fatigue (negative outcome)
Change in Perception of Thirst
0-9 (no thirst to extreme thirst), scale that indicates how thirsty the subject feels, a higher score is considered a negative outcome (more thirsty)
Change in Environmental Perception
Scale to assess participant perception of the environmental conditions, measurement scale identified as the modified environmental symptoms questionnaire (ESQ) which includes a minimum scale of "Not at all" and a maximum scale of "Extreme". Outcomes are considered worse when associated with greater extremes in documented answers
Change in Rating of Perceived Exertion
6-20 scale to assess participant perceived exertion levels (how hard they are working) during exercise-heat stress bouts. A greater score indicates greater levels of exertion.
Change in Sleep Quality
Scale to assess participant sleep habits including quantity and quality, measurement scale identified as the Kalinska sleep diary (KSD) which is a 9-point scale with increasing severity from 1 (extremely alert) to 9 (extremely sleepy - fighting sleep)
Change in Body Mass
Participants will have nude body weight (kg) assessed at the beginning and end of each testing session
Change in Reproductive Hormone State - Estradiol
Blood plasma samples will be collected for the measurement of circulating estradiol
Change in Reproductive Hormone State - Progesterone
Blood plasma samples will be collected for the measurement of circulating progesterone
Change in Reproductive Hormone State - Testosterone
Blood plasma samples will be collected for the measurement of circulating testosterone
Change in Reproductive Hormone State - LH
Blood plasma samples will be collected for the measurement of circulating luteinizing hormone (LH)
Change in Reproductive Hormone State - FSH
Blood plasma samples will be collected for the measurement of circulating follicle stimulating hormone (FSH)
Change in Cardiovascular Response - Blood Pressure
Blood pressure will be measured manually prior to each testing session with the documentation of systolic and diastolic measurements

Full Information

First Posted
December 16, 2022
Last Updated
December 28, 2022
Sponsor
University of Connecticut
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT05678738
Brief Title
Acquiring and Targeting Heat Exposures Necessary for Action
Acronym
ATHENA
Official Title
Enhancing Lethality by Targeting Cognitive and Physiological Mechanisms of Female Warfighter Resiliency to Consecutive Days of Intense Exercise in the Heat
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2021 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to better understand ways that women and men differ physiologically, cognitively, physically, and cellularly to better prescribe helpful interventions that will prevent injury and risk of conditions like exertional heat illnesses or heatstroke. The main questions this project aims to answer are: What is the relative stress contributing to performance differences between women and men during intense exercise in extremely hot and humid environments in response to exertional heat stress? What is the relative contribution of responses in adipose tissue, cardiovascular tissue, gut microbiota, and musculoskeletal tissue on heat tolerance in women (vs. men) to exertional heat stress? What is the impact of adding an antioxidant juice consumption regime and will it assist in enhancing performance during an acute bout of exercise-heat stress before and after heat acclimation? Subjects enrolled and approved for participation will perform: a heat acclimation protocol which includes the completion of 5 days of prescribed exercise-heat exposure two separate acute exercise-heat exposures for the assessment of thermotolerance and the investigation of potential enhancements in thermoregulatory performance that may occur after the completion of a 5-day heat acclimation protocol a subset of subjects enrolled and approved for participation who opt in to antioxidant berry supplement consumption will either consume the active or placebo product throughout their participation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heat Intolerance, Heat Stress, Fatigue; Heat
Keywords
Sex Differences, Physical Performance, Body Composition, Heat Acclimation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will consist of both male and female subjects who will be exposed to similar bouts of exertional heat stress. Analysis will be completed to assess for potential sex-based differences in outcomes measured (male vs. female). Participants (both male and female) who opt-in for antioxidant berry supplementation will be assigned to a subgroup parallel study model where subjects will be exposed to similar bouts of exertional heat stress while consuming either the antioxidant or placebo supplement.
Masking
ParticipantInvestigator
Masking Description
Participants who opt-in for antioxidant berry supplementation will be randomly assigned to either the group receiving the bioactive ingredient (berry fruit juice) or the placebo group. Both groups will receive 300mL to consume every morning and afternoon during participation.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acute and Chronic Exercise-Heat Stress
Arm Type
Experimental
Arm Description
All participants (male and female) will be exposed to repeated bouts of exercise-heat stress.
Arm Title
Exercise-Heat Stress + Antioxidant Berry Supplementation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exercise-Heat Stress + Placebo (Non-juice) Supplementation
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Antioxidant Berry Supplementation
Intervention Description
Participants who opt-in will be instructed to consume 300mL of the bioactive (antioxidant berry) supplement every morning and afternoon during days of participation.
Intervention Type
Other
Intervention Name(s)
Acute and Chronic Exercise-Heat Stress
Intervention Description
All participants (male and female) will be exposed to repeated bouts of exercise-heat stress.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo (non-juice) Supplementation
Intervention Description
Participants who opt-in will be instructed to consume 300mL of the placebo (non-juice) supplement every morning and afternoon during days of participation.
Primary Outcome Measure Information:
Title
Change in Rectal Temperature at Rest
Description
Rectal thermometer will be self-inserted by participants to assess core temperature prior to exercise-heat stress bouts
Time Frame
Through study completion, an average of 14 days
Title
Change in Rectal Temperature Rate of Rise
Description
Rectal thermometer will be self-inserted by participants to assess core temperature during exercise-heat stress bouts
Time Frame
Through study completion, an average of 14 days
Title
Change in Rectal Temperature at Thermal Threshold (38.5C)
Description
Rectal thermometer will be self-inserted by participants to assess core temperature during exercise-heat stress bouts at the thermal threshold of 38.5C
Time Frame
Measured throughout 5 90-minute exercise-heat stress bouts (heat acclimation sessions)
Title
Change in Mean Skin Temperature
Description
Prior to start of exercise, participants will be instrumented with iButton skin temperature sensors on the chest, shoulder, abdomen, neck, back, thigh, and calf
Time Frame
Through study completion, an average of 14 days
Title
Change in Heart Rate
Description
A heart rate monitor will be worn by participants throughout the exercise-heat stress bouts
Time Frame
Through study completion, an average of 14 days
Title
Change in Heart Rate at Thermal Threshold (38.5C)
Description
A heart rate monitor will be worn by participants throughout the exercise-heat stress bouts to assess HR at the thermal threshold of 38.5C
Time Frame
Measured throughout 5 90-minute exercise-heat stress bouts (heat acclimation sessions)
Title
Change in Whole Body Sweat Rate
Description
Difference in body weight measurement measured prior to and at the cessation of each exercise-heat stress bout
Time Frame
Measured at the beginning and end of 5 90-minute exercise-heat stress bouts (heat acclimation sessions)
Title
Change in Sweat Metabolite and Protein Expression
Description
Sweat samples will be collected and assessed for metabolite and protein expression discovery via mass spectrometry
Time Frame
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)
Title
Change in Cognitive Measures - Visual Vigilance
Description
Participants will perform an assessment of visual vigilance through a validated computer programming system. The test is part of a larger Testing battery which should take approximately 30 minutes for completion
Time Frame
Measurement completed immediately after one exercise-heat stress bout (Heat Tolerance Test 2 - days 6 and 13) both before and immediately after heat acclimation
Title
Change in Cognitive Measures - Psychomotor Vigilance
Description
Participants will perform an assessment of psychomotor vigilance through a validated computer programming system. The test is part of a larger Testing battery which should take approximately 30 minutes for completion
Time Frame
Measurement completed immediately after one exercise-heat stress bout (Heat Tolerance Test 2 - days 6 and 13) both before and immediately after heat acclimation
Title
Change in Cognitive Measures - Four Choice Task
Description
Participants will perform an assessment of four choice task success through a validated computer programming system. The test is part of a larger Testing battery which should take approximately 30 minutes for completion
Time Frame
Measurement completed immediately after one exercise-heat stress bout (Heat Tolerance Test 2 - days 6 and 13) both before and immediately after heat acclimation
Title
Change in Cognitive Measures - Match to Sample
Description
Participants will perform an assessment of match to sample success through a validated computer programming system. The test is part of a larger Testing battery which should take approximately 30 minutes for completion
Time Frame
Measurement completed immediately after one exercise-heat stress bout (Heat Tolerance Test 2 - days 6 and 13) both before and immediately after heat acclimation
Title
Change in Cognitive Measures - Repeated Acquisition
Description
Participants will perform an assessment of repeated acquisition through a validated computer programming system. The test is part of a larger Testing battery which should take approximately 30 minutes for completion
Time Frame
Measurement completed immediately after one exercise-heat stress bout (Heat Tolerance Test 2 - days 6 and 13) both before and immediately after heat acclimation
Title
Change in Cognitive Measures - Grammatical Reasoning
Description
Participants will perform an assessment of grammatical reasoning through a validated computer programming system. The test is part of a larger Testing battery which should take approximately 30 minutes for completion
Time Frame
Measurement completed immediately after one exercise-heat stress bout (Heat Tolerance Test 2 - days 6 and 13) both before and immediately after heat acclimation
Title
Change in Cognitive Measures - Profile of Mood States
Description
Participants will perform an assessment of profile of mood states through a validated computer programming system. The test is part of a larger Testing battery which should take approximately 30 minutes for completion
Time Frame
Measurement completed immediately after one exercise-heat stress bout (Heat Tolerance Test 2 - days 6 and 13) both before and immediately after heat acclimation
Title
Change in Cognitive Measures - Stroop Task
Description
Participants will perform an assessment of stroop task success through a validated computer programming system. The test is part of a larger Testing battery which should take approximately 30 minutes for completion
Time Frame
Measurement completed immediately after one exercise-heat stress bout (Heat Tolerance Test 2 - days 6 and 13) both before and immediately after heat acclimation
Title
Change in Physical Performance - Anaerobic Performance
Description
Participants will be assessed for anaerobic performance with the completion of a 400 meter sprint for time. This test is part of a larger physical performance battery test which should take approximately 30 minutes for completion
Time Frame
Measurements completed immediately after the cognitive battery performed during the Heat Tolerance Test 2 (days 6 and 13) both before and immediately after heat acclimation
Title
Change in Physical Performance - Agility Performance
Description
Participants will be assessed for anaerobic performance with the completion of a quick feet agility test. This test is part of a larger physical performance battery test which should take approximately 30 minutes for completion
Time Frame
Measurements completed immediately after the cognitive battery performed during the Heat Tolerance Test 2 (days 6 and 13) both before and immediately after heat acclimation
Title
Change in Physical Performance - Upper Body Strength Performance
Description
Participants will be assessed for upper body strength performance with the completion of a handgrip strength test. This test is part of a larger physical performance battery test which should take approximately 30 minutes for completion
Time Frame
Measurements completed immediately after the cognitive battery performed during the Heat Tolerance Test 2 (days 6 and 13) both before and immediately after heat acclimation
Title
Change in Physical Performance - Lower Body Power Performance
Description
Participants will be assessed for lower body power performance with the completion of a vertical jump test. This test is part of a larger physical performance battery test which should take approximately 30 minutes for completion
Time Frame
Measurements completed immediately after the cognitive battery performed during the Heat Tolerance Test 2 (days 6 and 13) both before and immediately after heat acclimation
Title
Change in Physical Performance - Lower Body Kinematic Performance
Description
Participants will be assessed for lower body kinematic performance with the completion of the Landing Error Scoring System (LESS) Test. This test is part of a larger physical performance battery test which should take approximately 30 minutes for completion
Time Frame
Measurements completed immediately after the cognitive battery performed during the Heat Tolerance Test 2 (days 6 and 13) both before and immediately after heat acclimation
Title
Change in Physical Performance - Balance Performance
Description
Participants will be assessed for balance performance with the completion of the Balance Error Scoring System (BESS) Test. This test is part of a larger physical performance battery test which should take approximately 30 minutes for completion
Time Frame
Measurements completed immediately after the cognitive battery performed during the Heat Tolerance Test 2 (days 6 and 13) both before and immediately after heat acclimation
Title
Change in Musculoskeletal Gene and Protein Expression
Description
Musculoskeletal tissue samples will be collected for analysis via RNA-seq
Time Frame
Measurement completed after the performance of an exercise-heat stress bout and physical performance battery (Heat Tolerance Test 2 - days 6 and 13) both before and immediately after heat acclimation
Title
Change in Musculoskeletal Fiber-Typing
Description
Musculoskeletal tissue samples will be collected for fiber-type analysis via immunohistochemical procedures
Time Frame
Measurement completed after the performance of an exercise-heat stress bout and physical performance battery (Heat Tolerance Test 2 - days 6 and 13) both before and immediately after heat acclimation
Title
Change in Musculoskeletal Mitochondrial Function
Description
Musculoskeletal tissue samples will be collected for analysis of mitochondrial function
Time Frame
Measurement completed after the performance of an exercise-heat stress bout and physical performance battery (Heat Tolerance Test 2 - days 6 and 13) both before and immediately after heat acclimation
Title
Change in Subcutaneous Abdominal Tissue (SCAAT) Lipolysis Rate
Description
SCAAT lipolysis rate (interstitial glycerol and ethanol output:input) will be collected and assessed for fat mobilization and subcutaneous adipose tissue blood flow during exercise-heat stress bouts
Time Frame
Measurement completed after the performance of an exercise-heat stress bout and physical performance battery (Heat Tolerance Test 2 - days 6 and 13) both before and immediately after heat acclimation
Title
Change in Resting Energy Expenditure and Macronutrient Oxidation
Description
Participant resting energy expenditure, fat oxidation, and carbohydrate oxidation will be assessed via indirect calorimetry for the measurement of respiratory quotient and respiratory exchange ratio
Time Frame
Measurement completed after the performance of an exercise-heat stress bout and physical performance battery (Heat Tolerance Test 2 - days 6 and 13) both before and immediately after heat acclimation
Title
Change in Circulatory Indicators of Lipid Metabolism - NEFAs
Description
Blood samples will be collected and assessed for the expression of lipid metabolism biomarker Non-Essential Fatty Acids (NEFAs)
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Circulatory Indicators of Lipid Metabolism - Insulin
Description
Blood samples will be collected and assessed for the expression of lipid metabolism biomarker Insulin
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Circulatory Indicators of Lipid Metabolism - IGF-1
Description
Blood samples will be collected and assessed for the expression of lipid metabolism biomarker Insulin Growth Factor-1 (IGF-1)
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Circulatory Indicators of Stress - Epinephrine
Description
Blood samples will be collected and assessed for the expression of physiological stress biomarker Epinephrine
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Circulatory Indicators of Stress - Norepinephrine
Description
Blood samples will be collected and assessed for the expression of physiological stress biomarker Norepinephrine
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Circulatory Indicators of Stress - Cortisol
Description
Blood samples will be collected and assessed for the expression of physiological stress biomarker Cortisol
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Circulatory RNA Content
Description
Blood samples will be collected and assessed for intracellular RNA content
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Circulatory Indicators of Inflammation - IL-1B
Description
Blood samples will be collected and assessed for the expression of inflammatory biomarker IL-1B
Time Frame
Measurement completed during the completion of exercise-heat stress bouts (Heat Tolerance Tests 1 [days 5 and 12] and 2 [days 6 and 13]) both before and immediately after heat acclimation
Title
Change in Circulatory Indicators of Inflammation - TNF-a
Description
Blood samples will be collected and assessed for the expression of inflammatory biomarker TNF-a
Time Frame
Measurement completed during the completion of exercise-heat stress bouts (Heat Tolerance Tests 1 [days 5 and 12] and 2 [days 6 and 13]) both before and immediately after heat acclimation
Title
Change in Circulatory Indicators of Inflammation - IFN-gamma
Description
Blood samples will be collected and assessed for the expression of inflammatory biomarker IFN-gamma
Time Frame
Measurement completed during the completion of exercise-heat stress bouts (Heat Tolerance Tests 1 [days 5 and 12] and 2 [days 6 and 13]) both before and immediately after heat acclimation
Title
Change in Gut Microbiome Diversity
Description
Stool samples will be collected and assessed for the impact of gut microbiome diversity on heat intolerance
Time Frame
Measurement completed prior to the completion of an exercise-heat stress bout (Heat Tolerance Test 2) both before and after heat acclimation
Title
Change in Saliva Metabolite Expression
Description
Saliva samples will be collected and assessed for metabolite expression
Time Frame
Measurement completed during each exercise-heat stress bout (Heat Tolerance Tests 1 and 2) both before and after heat acclimation as well as the final heat acclimation session (HA5)
Title
Change in Thermal Sensation
Description
0-8 Scale (cold to hot) that indicated how cold or hot the participant feels. 0 = extremely cold, 8 = extremely hot
Time Frame
Through study completion, an average of 14 days
Title
Change in Recovery
Description
Participants will be provided a WHOOP strap after the completion of their baseline visit and will be instructed on how to download the associated application and use of the device. The WHOOP device will be used to provide data on sleep quality and quantity, strain, and recovery
Time Frame
Throughout study completion, an average of 14 days
Secondary Outcome Measure Information:
Title
Change in Perception of Fatigue
Description
0-10 (no fatigue to extreme fatigue), scale indicates how fatigued the participant feels. High score indicates more fatigue (negative outcome)
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Perception of Thirst
Description
0-9 (no thirst to extreme thirst), scale that indicates how thirsty the subject feels, a higher score is considered a negative outcome (more thirsty)
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Environmental Perception
Description
Scale to assess participant perception of the environmental conditions, measurement scale identified as the modified environmental symptoms questionnaire (ESQ) which includes a minimum scale of "Not at all" and a maximum scale of "Extreme". Outcomes are considered worse when associated with greater extremes in documented answers
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Rating of Perceived Exertion
Description
6-20 scale to assess participant perceived exertion levels (how hard they are working) during exercise-heat stress bouts. A greater score indicates greater levels of exertion.
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Sleep Quality
Description
Scale to assess participant sleep habits including quantity and quality, measurement scale identified as the Kalinska sleep diary (KSD) which is a 9-point scale with increasing severity from 1 (extremely alert) to 9 (extremely sleepy - fighting sleep)
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Body Mass
Description
Participants will have nude body weight (kg) assessed at the beginning and end of each testing session
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Reproductive Hormone State - Estradiol
Description
Blood plasma samples will be collected for the measurement of circulating estradiol
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Reproductive Hormone State - Progesterone
Description
Blood plasma samples will be collected for the measurement of circulating progesterone
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Reproductive Hormone State - Testosterone
Description
Blood plasma samples will be collected for the measurement of circulating testosterone
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Reproductive Hormone State - LH
Description
Blood plasma samples will be collected for the measurement of circulating luteinizing hormone (LH)
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Reproductive Hormone State - FSH
Description
Blood plasma samples will be collected for the measurement of circulating follicle stimulating hormone (FSH)
Time Frame
Throughout study completion, an average of 14 days
Title
Change in Cardiovascular Response - Blood Pressure
Description
Blood pressure will be measured manually prior to each testing session with the documentation of systolic and diastolic measurements
Time Frame
Throughout study completion, an average of 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants will be healthy men and women, aged 18-50 years, who speak and read the English language fluently. This is required because some of the cognitive tests test grammatical reasoning and offer directional cues recorded as audio files in English. VO2max tests will provide evidence of level of aerobic fitness required to participate in this study. The investigators will use ≥45 ml·kg-1·min-1 for male participants, ≥40 ml·kg-1·min-1 for female participants as our threshold for inclusion. The target composition of our subject sample is 50% men and 50% women. No difficulties with vision, hearing, or ability to read a computer screen and operate a computer keyboard and mouse. Exclusion Criteria: unable to visit the laboratory on the required, consistent schedule and consecutive required days (Days 2 and 3, Days 12 and 13) any contraindications to participating in exercise lasting 60-120 minutes daily during a period of 2 consecutive days, 5 days within an 8-day period, and 2 additional days (if subjects elect to participate in the entire study, all options), screening will include resting blood pressure to exclude pre-hypertensive or hypertensive participants (resting BP > 120 mmHg and 80mmHg systolic and diastolic, respectively) any contraindications to exposure to exercise-heat stress (e.g., medications that affect thermoregulation, family or personal history of issues with anesthetics that indicate possible susceptibility to malignant hyperthermia, evidence of past heat intolerance) tobacco use or electronic cigarettes (e-cigarettes) within the past 6 months chronic illness (including diabetes, metabolic syndrome, thyroid disease, for example) or other chronic illnesses that make it unsafe for participants to participate in daily rigorous exercise in the heat regular supplementation with blood thinners, including the use of aspirin acute illness (e.g., influenza, head cold, gastrointestinal illness) during the week of scheduled testing current positive COVID-test or infection and past COVID infection within past 6 months contraindications to blood draw and if elected to be considered for participation with microdialysis and skeletal muscle biopsy procedures, contraindications to those individual procedures for subjects who may not complete a DXA scan, history of claustrophobia history of allergic reactions to medical tape and/or latex currently participating in "non-traditional" diets including diets such as intermittent fasting, caloric restriction, highly limited consumption of large food classes (e.g., vegan) consumption of antioxidant supplementation on a regular, long-term basis outside of the aronia supplementation regime for the study limited decision-making ability inability to participate in extended physical activity on a treadmill (i.e., standing, running, jogging, walking) consumption of a non-traditional diet including diets such as intermittent fasting, caloric restriction, highly limited consumption of large food classes (e.g., vegan) (this includes individuals who are suffering with current diagnosed or undiagnosed eating disorder) allergy to povidone, ethyl chloride, lidocaine, or bacitracin pregnant or positive pregnancy test during DXA pre-procedures (see DXA SOP) allergy to aronia berries, monkfruit, or sham juice ingredients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine C Lee, PhD
Phone
860-486-3169
Email
elaine.c.lee@uconn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Douglas J Casa, PhD
Phone
860 486-3624
Email
douglas.casa@uconn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas J Casa, PhD
Organizational Affiliation
Korey Stringer Institute - UConn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Performance Laboratory at the University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeb Struder
Phone
860-486-3077
Email
jeb.struder@uconn.edu
First Name & Middle Initial & Last Name & Degree
Staci Thornton
Email
staci.thornton@uconn.edu
First Name & Middle Initial & Last Name & Degree
Douglas J Casa
First Name & Middle Initial & Last Name & Degree
Elaine C Lee

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Acquiring and Targeting Heat Exposures Necessary for Action

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