How Exercise Signals Health Responses
Primary Purpose
Overweight
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
50% heart rate reserve (HRR) low intensity exercise
75% HRR moderate intensity exercise
Control no exercise
Sponsored by

About this trial
This is an interventional other trial for Overweight
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
Sites / Locations
- USDA Grand Forks Human Nutrition Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Trained
Untrained
Arm Description
Participants who have been CrossFit training at least 3 times per week for the previous 3 months. These individuals will be invited in person to participate in the study.
Nonactive/non--exercise trained participants who have participated in any type of exercise no more than 2 times per week for the past 3 months. These individuals will be recruited from the general public.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Change in plasma adipokine concentration
Blood samples collected during exercise will be analyzed for the concentration of plasma adipokines including myonectin.
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 (TNFα), C-reactive protein (CRP), fibrinogen, and IGF1.
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).
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04307212
First Posted
February 27, 2020
Last Updated
September 24, 2023
Sponsor
USDA Grand Forks Human Nutrition Research Center
1. Study Identification
Unique Protocol Identification Number
NCT04307212
Brief Title
How Exercise Signals Health Responses
Official Title
Exercise is Medicine. How Exercise Signals Health Responses
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
September 12, 2023 (Actual)
Study Completion Date
September 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
USDA Grand Forks Human Nutrition Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trained
Arm Type
Active Comparator
Arm Description
Participants who have been CrossFit training at least 3 times per week for the previous 3 months. These individuals will be invited in person to participate in the study.
Arm Title
Untrained
Arm Type
Active Comparator
Arm Description
Nonactive/non--exercise trained participants who have participated in any type of exercise no more than 2 times per week for the past 3 months. These individuals will be recruited from the general public.
Intervention Type
Other
Intervention Name(s)
50% heart rate reserve (HRR) low intensity exercise
Intervention Description
Trained and untrained participants will exercise at a constant load intensity of 50% HRR (low intensity)
Intervention Type
Other
Intervention Name(s)
75% HRR moderate intensity exercise
Intervention Description
Trained and untrained participants will exercise at a constant load intensity of 75% HRR (moderate intensity)
Intervention Type
Other
Intervention Name(s)
Control no exercise
Intervention Description
Trained and untrained participants will have a no exercise control day
Primary Outcome Measure Information:
Title
Change in plasma myokine concentration
Description
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).
Time Frame
Pre-exercise, 0, 30, 60, 90 minutes post-exercise
Secondary Outcome Measure Information:
Title
Change in plasma adipokine concentration
Description
Blood samples collected during exercise will be analyzed for the concentration of plasma adipokines including myonectin.
Time Frame
Pre-exercise, 0, 30, 60, 90 minutes post-exercise
Title
Change in plasma cytokine concentration
Description
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.
Time Frame
Pre-exercise, 0, 30, 60, 90 minutes post-exercise
Title
Relative reinforcing value (RRV) of exercise
Description
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).
Time Frame
Week 0
Title
Minutes of physical activity, as assessed by activity tracker
Description
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.
Time Frame
Week 0
Title
Usual modes of sedentary behavior
Description
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.
Time Frame
Week 0
Title
Preference for intense physical activity and tolerance for exercise discomfort
Description
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.
Time Frame
Week 0
Title
Fat mass as assessed by dual energy x-ray absorptiometry (DXA) scans
Description
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.
Time Frame
Week 0
Title
Fat-free lean mass as assessed by DXA scans
Description
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.
Time Frame
Week 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Roemmich, PhD
Organizational Affiliation
USDA Grand Forks Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Grand Forks Human Nutrition Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/
Description
USDA Grand Forks Human Nutrition Research Center Current Nutrition Studies
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How Exercise Signals Health Responses
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