NCT04307212

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2023

Completed
Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

3.7 years

First QC Date

February 27, 2020

Last Update Submit

April 8, 2025

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

  • 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).

    Pre-exercise, 0, 30, 60, 90 minutes post-exercise

Secondary Outcomes (8)

  • Change in plasma adipokine concentration

    Pre-exercise, 0, 30, 60, 90 minutes post-exercise

  • Change in plasma cytokine concentration

    Pre-exercise, 0, 30, 60, 90 minutes post-exercise

  • Relative reinforcing value (RRV) of exercise

    Week 0

  • Minutes of physical activity, as assessed by activity tracker

    Week 0

  • Usual modes of sedentary behavior

    Week 0

  • +3 more secondary outcomes

Study Arms (2)

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.

Other: 50% heart rate reserve (HRR) low intensity exerciseOther: 75% HRR moderate intensity exerciseOther: 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.

Other: 50% heart rate reserve (HRR) low intensity exerciseOther: 75% HRR moderate intensity exerciseOther: Control no exercise

Interventions

50% heart rate reserve (HRR) low intensity exerciseOTHER

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

TrainedUntrained
75% HRR moderate intensity exerciseOTHER

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

TrainedUntrained
Control no exerciseOTHER

Trained and untrained participants will have a no exercise control day

TrainedUntrained

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No tobacco use
  • Not pregnant, lactating, or planning to become pregnant in the next 6 months
  • Regular menses for the past 6 months
  • No physical limitations
  • Has the ability to safely perform exercise

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

Location

Related Links

MeSH Terms

Conditions

Overweight

Interventions

Recombinational DNA Repair

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DNA RepairBiochemical PhenomenaChemical PhenomenaGenetic PhenomenaHomologous RecombinationRecombination, Genetic

Study Officials

  • James Roemmich, PhD

    USDA Grand Forks Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2020

First Posted

March 13, 2020

Study Start

January 10, 2020

Primary Completion

September 12, 2023

Study Completion

September 12, 2023

Last Updated

April 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)