Grand Forks, North Dakota 58203

  • Overweight

Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

GFHNRC409


NCT ID:

NCT04307212


Secondary ID:


Study Acronym:


Brief Title:

How Exercise Signals Health Responses


Official Title:

Exercise is Medicine. How Exercise Signals Health Responses


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

USDA Grand Forks Human Nutrition Research Center


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:James Roemmich, PhD
Principal Investigator
USDA Grand Forks Human Nutrition Research Center
Primary Contact:James Roemmich, PhD
701-795-8272
james.roemmich@usda.gov
Backup Contact:William Siders, PhD
701-795-8430
william.siders@usda.gov

Study Dates

Start Date:January 10, 2020
Completion Date:July 2023
Completion Type:Anticipated
Primary Completion Date:July 2023
Primary Completion Type:Anticipated
Verification Date:April 2021
Last Changed Date:April 8, 2021
First Received Date:February 27, 2020

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Fat-free lean mass as assessed by DXA scans
Time Frame:Week 0
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Fat mass as assessed by dual energy x-ray absorptiometry (DXA) scans
Time Frame:Week 0
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Preference for intense physical activity and tolerance for exercise discomfort
Time Frame:Week 0
Safety Issues:False
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 prefere
Outcome Type:Secondary Outcome
Measure:Usual modes of sedentary behavior
Time Frame:Week 0
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure:Minutes of physical activity, as assessed by activity tracker
Time Frame:Week 0
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Relative reinforcing value (RRV) of exercise
Time Frame:Week 0
Safety Issues:False
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).
Outcome Type:Secondary Outcome
Measure:Change in plasma cytokine concentration
Time Frame:Pre-exercise, 0, 30, 60, 90 minutes post-exercise
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Change in plasma adipokine concentration
Time Frame:Pre-exercise, 0, 30, 60, 90 minutes post-exercise
Safety Issues:False
Description:Blood samples collected during exercise will be analyzed for the concentration of plasma adipokines including myonectin.
Outcome Type:Primary Outcome
Measure:Change in plasma myokine concentration
Time Frame:Pre-exercise, 0, 30, 60, 90 minutes post-exercise
Safety Issues:False
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) 1

Study Interventions

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

Study Arms

Study Arm Type:Active Comparator
Arm Name:Untrained
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.
Study Arm Type:Active Comparator
Arm Name:Trained
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.

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:USDA Grand Forks Human Nutrition Research Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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