Clinical trial NCT02310334: The Pacing (Guided Vs Unguided) Strategies Study
Official title: The Impact of Real-Time Physiological Status Based Pacing Guidance on Physiological Strain for Exercising Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Temperature Changes
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: United States Army Research Institute of Environmental Medicine
First posted: 2014-12-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objectives of this study are to demonstrate that real time physiological status monitoring and the use of optimization techniques during exercise can have a positive impact on physiological status, and to collect metabolic flexibility profiles of young fit adults during rest and exercise.

Detailed description: This experiment aims to accomplish two goals: collect additional metabolic flexibility data with young fit adults in response to exercise; and demonstrate that automated pace guidance generated from real-time thermal-work strain monitoring and an optimized pacing policy will allow less stressful completion of a timed (60 minute) treadmill exercise of 5 miles. Each participant will undergo two treatments of first UNGUIDED followed by GUIDED exercise. The two exercise sessions will be conducted as part of a \~24 hour stay in an indirect calorimetry chamber.

Eligibility criteria: Inclusion Criteria:

* Male and Female
* Ages 18 to 29 at the beginning of the study
* Relatively fit can run 2 miles in under 16 minutes

Exclusion Criteria:

* History of Skin Sensitivity to Nickel
* Hypertension
* Alcoholism
* Diabetes
* Pregnant
* Age \>29
* Cannot run 2 miles in less than 16 minutes
* No regular weekly exercise
* Difficulty Swallowing Food or Large Pills
* Diverticulitis
* Inflammatory Bowel Disease
* Peptic Ulcer Disease
* Crohn's Disease
* Ulcerative Colitis
* Previous Gastrointestinal Surgery
* Possible Nuclear Magnetic Resonance Scan
* Women who have given birth during the previous 12 months
* Pregnant women or women who plan to become pregnant or become pregnant during the study
* Lactating women
* History or presence of kidney disease, liver disease, certain cancers, gastrointestinal, pancreatic, other metabolic diseases, or malabsorption syndromes
* History of bariatric or certain other surgeries related to weight control
* Smokers or other tobacco users (for at least 6 months prior to the start of the study)
* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
* Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months
* Unable or unwilling to give informed consent or communicate with study staff.
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
* Blood donation within the previous month

Primary outcomes:
measure: Physiological Strain Index (PSI)
timeFrame: During 2-hour exercise session
Secondary outcomes:
measure: Metabolic Flexibility
timeFrame: 24 hours
measure: Continuous Glucose Monitoring
timeFrame: 24 hours
measure: Self Perception Scales
timeFrame: During 2-hour exercise session
measure: Profile of Mood States (POMS) Questionnaire
timeFrame: During 2-hour exercise session
measure: Thermal Sensation Scale
timeFrame: During 2-hour exercise session
measure: Perceived Exertion Scale
timeFrame: During 2-hour exercise session
measure: Feeling Scale
timeFrame: During 2-hour exercise session
measure: Motivation
timeFrame: During 2-hour exercise session
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
affiliation: USDA Beltsville Human Nutrition Research Center
name: William V Rumpler, PhD
role: PRINCIPAL_INVESTIGATOR
References: