Clinical trial NCT04307212: How Exercise Signals Health Responses
Official title: Exercise is Medicine. How Exercise Signals Health Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2020-03-13
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A 3-way factorial design will be employed with training status as a between-subjects variable, and exercise intensity and time as within-subjects variables. The order of exercise intensity will be counterbalanced across subjects.
Primary purpose: OTHER

Brief summary: The purpose of this research is to determine the blood signals that promote health and well-being in response to exercise at different intensities.

Detailed description: Most studies find a dose-response relationship between exercise participation and all-cause mortality. In contrast, physical inactivity and consequent overweight or obese status is associated with a cadre of health consequences. Frequently, comorbidities of obesity are mechanistically linked via chronic low grade inflammation stemming from increases in adiposity. Although exercise is known to combat obesity and obesity related disease states, the mechanisms of action are not fully understood. Therefore, the investigators propose the following study in an attempt to elucidate anti- and pro-inflammatory endocrine responses to exercise. Initial studies in animal models have provided evidence that exercise induces long-term anti-inflammatory effects, potentially via myokine signaling following skeletal muscle activation. Humans are an ideal study population as the investigators can prescribe multiple exercise protocols that mimic human behavior, and control exercise intensity to meet recommendations. Also, humans allow the investigators to collect larger plasma samples and therefore measure more circulating proteins of interest over multiple time-points. Finally, the investigators can select individuals that exercise at different frequencies, allowing the investigators to analyze the differences in endocrine responses to exercise over differing levels of fitness. In summary, a human model will allow for a much better understanding of the human condition.

Eligibility criteria: Inclusion Criteria:

* No tobacco use
* Not pregnant, lactating, or planning to become pregnant in the next 6 months
* Regular menses for the past 6 months
* No use of hormone replacement for metabolic conditions (use of hormonal contraceptives are not exclusionary)
* No physical limitations
* Has the ability to safely perform exercise

Exclusion Criteria:

* Has no major health problems
* Cannot have known cardiovascular (cardiac, peripheral vascular, cerebrovascular), pulmonary (COPD, interstitial lung disease, cystic fibrosis) or metabolic (diabetes, thyroid disorders, renal or liver disease) disease

Primary outcomes:
measure: Change in plasma myokine concentration
timeFrame: Pre-exercise, 0, 30, 60, 90 minutes post-exercise
Secondary outcomes:
measure: Change in plasma adipokine concentration
timeFrame: Pre-exercise, 0, 30, 60, 90 minutes post-exercise
measure: Change in plasma cytokine concentration
timeFrame: Pre-exercise, 0, 30, 60, 90 minutes post-exercise
measure: Relative reinforcing value (RRV) of exercise
timeFrame: Week 0
measure: Minutes of physical activity, as assessed by activity tracker
timeFrame: Week 0
measure: Usual modes of sedentary behavior
timeFrame: Week 0
measure: Preference for intense physical activity and tolerance for exercise discomfort
timeFrame: Week 0
measure: Fat mass as assessed by dual energy x-ray absorptiometry (DXA) scans
timeFrame: Week 0
measure: Fat-free lean mass as assessed by DXA scans
timeFrame: Week 0
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: James Roemmich, PhD
role: PRINCIPAL_INVESTIGATOR
References: