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Completed

NCT Number: NCT04307212

How Exercise Signals Health Responses

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

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

50% heart rate reserve (HRR) low intensity exercise

Other

Trained and untrained participants will exercise at a constant load intensity of 50% HRR (low intensity)

75% HRR moderate intensity exercise

Other

Trained and untrained participants will exercise at a constant load intensity of 75% HRR (moderate intensity)

Control no exercise

Other

Trained and untrained participants will have a no exercise control day

Primary outcomes

  1. Change in plasma myokine concentration

    Time frame: Pre-exercise, 0, 30, 60, 90 minutes post-exercise

    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).

Secondary outcomes

  1. Change in plasma adipokine concentration

    Time frame: Pre-exercise, 0, 30, 60, 90 minutes post-exercise

    Blood samples collected during exercise will be analyzed for the concentration of plasma adipokines including myonectin.

  2. Change in plasma cytokine concentration

    Time frame: Pre-exercise, 0, 30, 60, 90 minutes post-exercise

    Blood samples collected during exercise will be analyzed for the concentration of plasma cytokines including IL-8, Tumor necrosis factor alpha (TNFα), C-reactive protein (CRP), fibrinogen, and IGF1.

  3. Relative reinforcing value (RRV) of exercise

    Time frame: Week 0

    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).

  4. Minutes of physical activity, as assessed by activity tracker

    Time frame: Week 0

    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.

  5. Usual modes of sedentary behavior

    Time frame: Week 0

    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.

  6. Preference for intense physical activity and tolerance for exercise discomfort

    Time frame: Week 0

    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.

  7. Fat mass as assessed by dual energy x-ray absorptiometry (DXA) scans

    Time frame: Week 0

    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.

  8. Fat-free lean mass as assessed by DXA scans

    Time frame: Week 0

    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.

Sponsors and collaborators

Lead sponsor

USDA Grand Forks Human Nutrition Research Center

Fed

Registry information

Official study title

Exercise is Medicine. How Exercise Signals Health Responses

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 13, 2020
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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