OverweightNCT04307212
How Exercise Signals Health Responses
A study testing 50% heart rate reserve (HRR) low intensity exercise and 75% HRR moderate intensity exercise in people with Overweight, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- 50% heart rate reserve (HRR) low intensity exercise and 75% HRR moderate intensity exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to 12 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
Official title: Exercise is Medicine. 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.
Read the 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.
- Conditions
- Overweight
- Being tested
- 50% heart rate reserve (HRR) low intensity exercise, 75% HRR moderate intensity exercise, Control no exercise
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50% heart rate reserve (HRR) low intensity exerciseOther
Trained and untrained participants will exercise at a constant load intensity of 50% HRR (low intensity)
75% HRR moderate intensity exerciseOther
Trained and untrained participants will exercise at a constant load intensity of 75% HRR (moderate intensity)
Control no exerciseOther
Trained and untrained participants will have a no exercise control day
| Study group | Role | What they receive |
|---|---|---|
| Trained | Active comparator | 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. Receives: Other: 50% heart rate reserve (HRR) low intensity exercise; Other: 75% HRR moderate intensity exercise; Other: Control no exercise |
| Untrained | Active comparator | 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. Receives: Other: 50% heart rate reserve (HRR) low intensity exercise; Other: 75% HRR moderate intensity exercise; Other: Control no exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Pre-exercise, 0, 30, 60, 90 minutes post-exercise
Secondary outcomes (8)
Change in plasma adipokine concentration
Blood samples collected during exercise will be analyzed for the concentration of plasma adipokines including myonectin.
Measured: Pre-exercise, 0, 30, 60, 90 minutes post-exercise
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.
Measured: Pre-exercise, 0, 30, 60, 90 minutes post-exercise
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).
Measured: Week 0
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.
Measured: Week 0
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.
Measured: Week 0
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.
Measured: Week 0
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.
Measured: Week 0
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.
Measured: Week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start10 Jan 2020
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- James Roemmich, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307212
- Sponsor's protocol ID
- GFHNRC409
- Status last verified
- Apr 2025
- First submitted
- 27 Feb 2020
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise is Medicine. How Exercise Signals Health Responses
- ClinicalTrials.gov ID
- NCT04307212
- Acronym / sponsor ID
- GFHNRC409
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Trained | Active comparator | Other: 50% heart rate reserve (HRR) low intensity exercise, Other: 75% HRR moderate intensity exercise, Other: Control no exerciseParticipants 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. |
| Untrained | Active comparator | Other: 50% heart rate reserve (HRR) low intensity exercise, Other: 75% HRR moderate intensity exercise, Other: Control no exerciseNonactive/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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50% heart rate reserve (HRR) low intensity exerciseTrained and untrained participants will exercise at a constant load intensity of 50% HRR (low intensity) | Other | Trained, Untrained |
| 75% HRR moderate intensity exerciseTrained and untrained participants will exercise at a constant load intensity of 75% HRR (moderate intensity) | Other | Trained, Untrained |
| Control no exerciseTrained and untrained participants will have a no exercise control day | Other | Trained, Untrained |
Primary outcome
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).
8 secondary outcomes
Change in plasma adipokine concentration
Time frame: Pre-exercise, 0, 30, 60, 90 minutes post-exercise
Change in plasma cytokine concentration
Time frame: Pre-exercise, 0, 30, 60, 90 minutes post-exercise
Relative reinforcing value (RRV) of exercise
Time frame: Week 0
Minutes of physical activity, as assessed by activity tracker
Time frame: Week 0
Usual modes of sedentary behavior
Time frame: Week 0
Preference for intense physical activity and tolerance for exercise discomfort
Time frame: Week 0
Fat mass as assessed by dual energy x-ray absorptiometry (DXA) scans
Time frame: Week 0
Fat-free lean mass as assessed by DXA scans
Time frame: Week 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- USDA Grand Forks Human Nutrition Research Center Current Nutrition StudiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Roemmich, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 50% heart rate reserve (HRR) low intensity exercise and 75% HRR moderate intensity exercise in people with Overweight, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma myokine concentration (time frame: Pre-exercise, 0, 30, 60, 90 minutes post-exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.