OverweightNCT02152501
Exercise and Weight Control
A study testing Exercise Energy Expenditure 300 kcal/day and Exercise Energy Expenditure 600 kcal/day in people with Overweight and Obese, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obese
- What is being tested?
- Exercise Energy Expenditure 300 kcal/day and Exercise Energy Expenditure 600 kcal/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jan 2017
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Reserach Center
Grand Forks, North Dakota, 58203
About this study
Official title: 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.
- Conditions
- Overweight, Obese
- Being tested
- Exercise Energy Expenditure 300 kcal/day, Exercise Energy Expenditure 600 kcal/day
- Keywords
- obese, overweight, exercise, energy expenditure differences, relative reinforcing values (RRV), food, physical activity, biological, neurobehavioral, behavioral
- Medical subject headings
- Overweight, Obesity, Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Energy Expenditure 300 kcal/dayOther
Exercise Energy Expenditure 600 kcal/dayOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise Energy Expenditure 300 kcal/day | Experimental | Subjects will be randomly assigned to this group and will exercise energy expenditure of 300 kcal/day. Receives: Other: Exercise Energy Expenditure 300 kcal/day |
| Exercise Energy Expenditure 600 kcal/day | Experimental | Subjects will be randomly assigned to this group and will exercise energy expenditure of 600 kcal/day. Receives: Other: Exercise Energy Expenditure 600 kcal/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Energy Balance as assessed by changes in adipose tissue
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).
Measured: End Training (weeks 10-12)
Secondary outcomes (9)
Change in relative reinforcing value (RRV) of food
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.
Measured: Pre-intervention (week 0) and End Training (weeks 10-12)
Average daily calories consumed as assessed by dietary recall
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).
Measured: Pre-intervention (week 0) and End Training (weeks 10-12)
Pre-post intervention changes in Ghrelin plasma levels
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).
Measured: Pre-intervention (week 0) and End Training (weeks 10-12)
Pre-post intervention changes in glucagon-like peptide 1 (GLP-1) plasma levels
Participants will provide a fasting blood sample collected in EDTA-coated and serum tubes. Changes in GLP-1 concentrations will be measured via ELISA.
Measured: Pre-intervention (week 0) and End Training (weeks 10-12)
Pre-post intervention changes in Ghrelin concentrations
Participants will provide a fasting blood sample collected in EDTA-coated and serum tubes. Changes in Ghrelin concentrations will be measured via ELISA.
Measured: Pre-intervention (week 0) and End Training (weeks 10-12)
Pre-post intervention changes in irisin concentrations
Participants will provide a fasting blood sample collected in EDTA-coated and serum tubes. Changes in irisin concentrations will be measured via ELISA.
Measured: Pre-intervention (week 0) and End Training (weeks 10-12)
Pre-post intervention changes in myostatin plasma levels
Participants will provide a fasting blood sample collected in EDTA-coated and serum tubes. Changes in myostatin levels will be measured via ELISA.
Measured: Pre-intervention (week 0) and End Training (weeks 10-12)
Change in relative reinforcing value (RRV) of physical activity
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.
Measured: Pre-intervention (week 0) and End Training (weeks 10-12)
Change in minutes of sedentary behavior, as assessed by activity tracker
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.
Measured: Pre-intervention (week 0) and End Training (weeks 10-12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startApr 2016
- Primary completionNov 2016
- Study completionJan 2017
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 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 GFHNRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152501
- Sponsor's protocol ID
- GFHNRC028
- Status last verified
- Apr 2025
- First submitted
- 22 May 2014
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 and Weight Control: A Search for Biological and Neurobehavioral Compensatory Mechanisms That Defend Against Exercise-Induced Negative Energy Balance
- ClinicalTrials.gov ID
- NCT02152501
- Acronym / sponsor ID
- GFHNRC028
- Conditions
- Overweight, Obese
- Keywords
- obese, overweight, exercise, energy expenditure differences, relative reinforcing values (RRV), food, physical activity, biological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Apr 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 2 Jun 2014 (estimated)
- 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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Energy Expenditure 300 kcal/day | Experimental | Other: Exercise Energy Expenditure 300 kcal/daySubjects will be randomly assigned to this group and will exercise energy expenditure of 300 kcal/day. |
| Exercise Energy Expenditure 600 kcal/day | Experimental | Other: Exercise Energy Expenditure 600 kcal/daySubjects will be randomly assigned to this group and will exercise energy expenditure of 600 kcal/day. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- < 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
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 |
|---|---|---|
| Exercise Energy Expenditure 300 kcal/day | Other | Exercise Energy Expenditure 300 kcal/day |
| Exercise Energy Expenditure 600 kcal/day | Other | Exercise Energy Expenditure 600 kcal/day |
Primary outcome
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).
9 secondary outcomes
Change in relative reinforcing value (RRV) of food
Time frame: 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)
Pre-post intervention changes in Ghrelin plasma levels
Time frame: 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)
Pre-post intervention changes in Ghrelin concentrations
Time frame: 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)
Pre-post intervention changes in myostatin plasma levels
Time frame: 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)
Change in minutes of sedentary behavior, as assessed by activity tracker
Time frame: Pre-intervention (week 0) and End Training (weeks 10-12)
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.
- 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 GFHNRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Energy Expenditure 300 kcal/day and Exercise Energy Expenditure 600 kcal/day in people with Overweight and Obese, 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 11 inclusion and 8 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?
Negative Energy Balance as assessed by changes in adipose tissue (time frame: End Training (weeks 10-12)). 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.