How Exercise Signals Health Responses

Overweight Clinical Trial

Official title:

Exercise is Medicine. How Exercise Signals Health Responses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04307212
• Other study ID #: GFHNRC409
• Status: Completed
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: September 12, 2023

Study information

• Verified date: September 2023
• Source: USDA Grand Forks Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 12, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight

Intervention

Other:
• 50% heart rate reserve (HRR) low intensity exercise
Trained and untrained participants will exercise at a constant load intensity of 50% HRR (low intensity)
• 75% HRR moderate intensity exercise
Trained and untrained participants will exercise at a constant load intensity of 75% HRR (moderate intensity)
• Control no exercise
Trained and untrained participants will have a no exercise control day

Locations

Country	Name	City	State
United States	USDA Grand Forks Human Nutrition Research Center	Grand Forks	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
USDA Grand Forks Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma myokine concentration	Blood samples collected during exercise will be analyzed for the concentration of plasma myokines including Brain Derived Neurotropic Factor (BDNF), Secreted Protein Acidic and Rich in Cysteine (SPARC), Leukemia Inhibitory Factor (LIF), Interleukin (IL) 15, IL-6, Myostatin, Irisin, Follistatin-like 1 (FSTL-1), Fibroblast Growth Factor 21 (FGF-21), IL-4, IL-7 receptor agonist (ra), IL-7, beta-aminoisobutyric acid (BAIBA), IL-1ra, Growth Differentiation Factor (GDF) 8, Insulin-Like Growth Factor-1 (IGF1).	Pre-exercise, 0, 30, 60, 90 minutes post-exercise
Secondary	Change in plasma adipokine concentration	Blood samples collected during exercise will be analyzed for the concentration of plasma adipokines including myonectin.	Pre-exercise, 0, 30, 60, 90 minutes post-exercise
Secondary	Change in plasma cytokine concentration	Blood samples collected during exercise will be analyzed for the concentration of plasma cytokines including IL-8, Tumor necrosis factor alpha (TNFa), C-reactive protein (CRP), fibrinogen, and IGF1.	Pre-exercise, 0, 30, 60, 90 minutes post-exercise
Secondary	Relative reinforcing value (RRV) of exercise	RRV of exercise will be assessed by evaluating the number of responses (mouse button presses) a participant is willing to complete to gain access to exercise or an alternative (magazines, word games, puzzles).	Week 0
Secondary	Minutes of physical activity, as assessed by activity tracker	Minutes of physical activity will be assessed by having participants wear an Actigraph accelerometer for 7 days (minimum 10 hours per day) on the right hip.	Week 0
Secondary	Usual modes of sedentary behavior	Usual modes of sedentary behavior will be determined via the validated International Physical Activity Questionnaire (IPAQ). The IPAQ measures habitual physical activity for the past 7 days and consists of four domains of physical activity: job-related (7 items), transportation (6 items), household/gardening (6 items), and leisure-time activities (6 items). To show sedentary behavior, two questions regarding time spent sitting are also included. The number of minutes for each activity class is multiplied by the MET score for that activity to convert the IPAQ data into metabolic equivalent scores (MET-min-week-1). Physical activity levels are then classified as being inactive, minimally active, and health-enhancing physically active.	Week 0
Secondary	Preference for intense physical activity and tolerance for exercise discomfort	Preference for intense physical activity and tolerance for exercise discomfort will be assessed by self-report questionnaire responses to the Preference for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q). The PRETIE-Q measures preference for high intensity vs. low intensity exercise and ability to persist or tolerate the discomfort associated with intense exercise. The PRETIE-Q consists of two subscales: Preference for Exercise Intensity and Tolerance of Exercise Intensity. Each subscale has 8 items rated on a 5-point response scale (range 8 - 40). Higher scores indicate greater preference for intense exercise and/or greater tolerance for exercise discomfort. Total scale scores are not used. Scale averages will be used.	Week 0
Secondary	Fat mass as assessed by dual energy x-ray absorptiometry (DXA) scans	Participants will be instructed to lie supine with hands by their sides on a GE Lunar iDXA machine for a full-body x-ray scan which will measure grams and percentage changed in fat mass.	Week 0
Secondary	Fat-free lean mass as assessed by DXA scans	Participants will be instructed to lie supine with hands by their sides on a GE Lunar iDXA machine for a full-body x-ray scan which will measure grams and percentage changed in fat-free lean mass.	Week 0

External Links

•   USDA Grand Forks Human Nutrition Research Center Current Nutrition Studies