How Exercise Signals Health Responses

NCT ID: NCT04307212

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2023-09-12

Brief Summary

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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

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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

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Trained

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.

Group Type ACTIVE_COMPARATOR

50% heart rate reserve (HRR) low intensity exercise

Intervention Type OTHER

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

75% HRR moderate intensity exercise

Intervention Type OTHER

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

Control no exercise

Intervention Type OTHER

Trained and untrained participants will have a no exercise control day

Untrained

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.

Group Type ACTIVE_COMPARATOR

50% heart rate reserve (HRR) low intensity exercise

Intervention Type OTHER

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

75% HRR moderate intensity exercise

Intervention Type OTHER

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

Control no exercise

Intervention Type OTHER

Trained and untrained participants will have a no exercise control day

Interventions

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50% heart rate reserve (HRR) low intensity exercise

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

Intervention Type OTHER

75% HRR moderate intensity exercise

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

Intervention Type OTHER

Control no exercise

Trained and untrained participants will have a no exercise control day

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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USDA Grand Forks Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Roemmich, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA Grand Forks Human Nutrition Research Center

Locations

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USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/

USDA Grand Forks Human Nutrition Research Center Current Nutrition Studies

Other Identifiers

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GFHNRC409

Identifier Type: -

Identifier Source: org_study_id

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