Exercise and Weight Control

April 8, 2025 updated by: USDA Grand Forks Human Nutrition Research Center

Exercise and Weight Control: A Search for Biological and Neurobehavioral Compensatory Mechanisms That Defend Against Exercise-Induced Negative Energy Balance

The purpose of this study is to research the effects of exercise on calories eaten and expended. The investigator expects to find out whether subjects change their eating and activity behaviors when starting an exercise program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Grand Forks, North Dakota, United States, 58203
        • USDA Grand Forks Human Nutrition Reserach Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 to 40 years old
  • BMI of 25.0 - 35 kg/m2
  • willing to consent to study conditions
  • not taking medications that affects energy expenditure or eating
  • not using tobacco or nicotine products
  • no food allergies or limitations to eating certain food that would prohibit them from eating the study foods
  • not be dieting to lose weight
  • no major health problems
  • cannot have known cardiovascular, pulmonary or metabolic disease
  • cannot be regularly exercising in an aerobic manner more than twice per week
  • must have a liking of at least 5 out of 10 for 75% of the study foods

Exclusion Criteria:

  • < 18 or > 40 years old
  • BMI < 25 or >35 kg/m2
  • currently pregnant or trying to become pregnant, or lactating
  • currently using tobacco or nicotine
  • taking medication that affects energy expenditure or eating
  • food allergies to foods used in the study
  • regularly exercising in an aerobic manner more than twice per week
  • major health problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise Energy Expenditure 300 kcal/day
Subjects will be randomly assigned to this group and will exercise energy expenditure of 300 kcal/day.
Other: Exercise Energy Expenditure 300 kcal/day
Experimental: Exercise Energy Expenditure 600 kcal/day
Subjects will be randomly assigned to this group and will exercise energy expenditure of 600 kcal/day.
Other: Exercise Energy Expenditure 600 kcal/day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Negative Energy Balance as assessed by changes in adipose tissue
Time Frame: End Training (weeks 10-12)
Whether participants were able to maintain a negative energy balance will be assessed by pre-post changes in stored adipose tissue, as assessed by a dual-energy x-ray absorptiometry scan (DEXA).
End Training (weeks 10-12)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in relative reinforcing value (RRV) of food
Time Frame: Pre-intervention (week 0) and End Training (weeks 10-12)
RRV of food will be assessed by evaluating the number of responses (mouse button presses) a participant is willing to complete to gain access to food or an alternative sedentary activity.
Pre-intervention (week 0) and End Training (weeks 10-12)
Average daily calories consumed as assessed by dietary recall
Time Frame: Pre-intervention (week 0) and End Training (weeks 10-12)
On two weekdays and one weekend day, participants will fill out the Automated Self-Administered 24-Hour Dietary Recall (ASA24) to estimate dietary intake (total energy, grams carbohydrates, fat, protein, alcohol).
Pre-intervention (week 0) and End Training (weeks 10-12)
Pre-post intervention changes in Ghrelin plasma levels
Time Frame: Pre-intervention (week 0) and End Training (weeks 10-12)
Participants will provide a fasting blood sample collected in ethylenediaminetetraacetic acid (EDTA)-coated and serum tubes. Changes in acylated Ghrelin will be measured via enzyme-linked immunosorbent assay (ELISA).
Pre-intervention (week 0) and End Training (weeks 10-12)
Pre-post intervention changes in glucagon-like peptide 1 (GLP-1) plasma levels
Time Frame: Pre-intervention (week 0) and End Training (weeks 10-12)
Participants will provide a fasting blood sample collected in EDTA-coated and serum tubes. Changes in GLP-1 concentrations will be measured via ELISA.
Pre-intervention (week 0) and End Training (weeks 10-12)
Pre-post intervention changes in Ghrelin concentrations
Time Frame: Pre-intervention (week 0) and End Training (weeks 10-12)
Participants will provide a fasting blood sample collected in EDTA-coated and serum tubes. Changes in Ghrelin concentrations will be measured via ELISA.
Pre-intervention (week 0) and End Training (weeks 10-12)
Pre-post intervention changes in irisin concentrations
Time Frame: Pre-intervention (week 0) and End Training (weeks 10-12)
Participants will provide a fasting blood sample collected in EDTA-coated and serum tubes. Changes in irisin concentrations will be measured via ELISA.
Pre-intervention (week 0) and End Training (weeks 10-12)
Pre-post intervention changes in myostatin plasma levels
Time Frame: Pre-intervention (week 0) and End Training (weeks 10-12)
Participants will provide a fasting blood sample collected in EDTA-coated and serum tubes. Changes in myostatin levels will be measured via ELISA.
Pre-intervention (week 0) and End Training (weeks 10-12)
Change in relative reinforcing value (RRV) of physical activity
Time Frame: Pre-intervention (week 0) and End Training (weeks 10-12)
RRV of physical activity will be assessed by evaluating the number of responses (mouse button presses) a subject is willing to complete to gain access to physical activity or a sedentary alternative.
Pre-intervention (week 0) and End Training (weeks 10-12)
Change in minutes of sedentary behavior, as assessed by activity tracker
Time Frame: Pre-intervention (week 0) and End Training (weeks 10-12)
Minutes of sedentary behavior (non-exercise activity) will be assessed by having participants wear an Actigraph accelerometer for 7 days (minimum 10 hours per day) on the right hip.
Pre-intervention (week 0) and End Training (weeks 10-12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
USDA Grand Forks Human Nutrition Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Roemmich, PhD, USDA GFHNRC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GFHNRC028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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