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CompletedNCT02152501Updated Apr 11, 2025

Exercise and Weight Control

An interventional study of Exercise Energy Expenditure 300 kcal/day and Exercise Energy Expenditure 600 kcal/day in Overweight and Obese, sponsored by USDA Grand Forks Human Nutrition Research Center. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-11.

Sponsored by USDA Grand Forks Human Nutrition Research Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Overweight
  • Obese

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Keywords

  • obese
  • overweight
  • exercise
  • energy expenditure differences
  • relative reinforcing values (RRV)
  • food
  • physical activity
  • biological
  • neurobehavioral
  • behavioral
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 29 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

USDA Grand Forks Human Nutrition Research Center is the lead sponsor of 58 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • 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

Interventions

  • OtherExercise Energy Expenditure 300 kcal/day
  • OtherExercise Energy Expenditure 600 kcal/day
06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: End Training (weeks 10-12)

Secondary outcomes

  1. 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.

    Time frame: Pre-intervention (week 0) and End Training (weeks 10-12)

  2. 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).

    Time frame: Pre-intervention (week 0) and End Training (weeks 10-12)

  3. 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).

    Time frame: Pre-intervention (week 0) and End Training (weeks 10-12)

  4. 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.

    Time frame: Pre-intervention (week 0) and End Training (weeks 10-12)

  5. 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.

    Time frame: Pre-intervention (week 0) and End Training (weeks 10-12)

  6. 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.

    Time frame: Pre-intervention (week 0) and End Training (weeks 10-12)

  7. 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.

    Time frame: Pre-intervention (week 0) and End Training (weeks 10-12)

  8. 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.

    Time frame: Pre-intervention (week 0) and End Training (weeks 10-12)

  9. 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.

    Time frame: Pre-intervention (week 0) and End Training (weeks 10-12)

07

Study locations

1 site
  • USDA Grand Forks Human Nutrition Reserach Center
    Grand Forks, North Dakota 58203, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02152501
Lead sponsor
USDA Grand Forks Human Nutrition Research Center
Responsible party
Sponsor
First posted
Jun 2, 2014
Start date
Apr 2016
Primary completion
Nov 2016
Completion
Jan 2017
Last update
Apr 11, 2025

Study contacts

James Roemmich, PhD
principal investigator · USDA GFHNRC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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