Acquiring and Targeting Heat Exposures Necessary for Action | NCT05678738

NCT05678738

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
BA200299	Other Grant/Funding Number	U.S. Army medical research and Development Command (USAMRDC)

Status Module

Name	Class
United States Department of Defense	FED

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acute and Chronic Exercise-Heat Stress	Experimental	All participants (male and female) will be exposed to repeated bouts of exercise-heat stress.	Other: Acute and Chronic Exercise-Heat Stress
Exercise-Heat Stress + Antioxidant Berry Supplementation	Active Comparator	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.	Dietary Supplement: Antioxidant Berry Supplementation Other: Acute and Chronic Exercise-Heat Stress
Exercise-Heat Stress + Placebo (Non-juice) Supplementation	Placebo Comparator	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.	Other: Acute and Chronic Exercise-Heat Stress Dietary Supplement: Placebo (non-juice) Supplementation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antioxidant Berry Supplementation	Dietary Supplement	Participants who opt-in will be instructed to consume 300mL of the bioactive (antioxidant berry) supplement every morning and afternoon during days of participation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Rectal Temperature at Rest	Rectal thermometer will be self-inserted by participants to assess core temperature prior to exercise-heat stress bouts	Through study completion, an average of 14 days
Change in Rectal Temperature Rate of Rise	Rectal thermometer will be self-inserted by participants to assess core temperature during exercise-heat stress bouts	Through study completion, an average of 14 days
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	Measured throughout 5 90-minute exercise-heat stress bouts (heat acclimation sessions)
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	Through study completion, an average of 14 days
Change in Heart Rate	A heart rate monitor will be worn by participants throughout the exercise-heat stress bouts	Through study completion, an average of 14 days
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	Measured throughout 5 90-minute exercise-heat stress bouts (heat acclimation sessions)

Secondary Outcomes

Measure	Description	Time Frame
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)	Throughout study completion, an average of 14 days
Change in Perception of Thirst

Eligibility Module

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

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages