Skip to content

Exercise and Weight Control

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02152501
Enrollment
29
Registered
2014-06-02
Start date
2016-04-30
Completion date
2017-01-31
Last updated
2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese, Overweight

Keywords

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

Brief 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.

Interventions

OTHERExercise Energy Expenditure 300 kcal/day
OTHERExercise Energy Expenditure 600 kcal/day

Sponsors

USDA Grand Forks Human Nutrition Research Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
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

* \< 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

Design outcomes

Primary

MeasureTime frameDescription
Negative Energy Balance as assessed by changes in adipose tissueEnd 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).

Secondary

MeasureTime frameDescription
Average daily calories consumed as assessed by dietary recallPre-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-post intervention changes in Ghrelin plasma levelsPre-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-post intervention changes in glucagon-like peptide 1 (GLP-1) plasma levelsPre-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-post intervention changes in Ghrelin concentrationsPre-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.
Change in relative reinforcing value (RRV) of foodPre-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-post intervention changes in myostatin plasma levelsPre-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.
Change in relative reinforcing value (RRV) of physical activityPre-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.
Change in minutes of sedentary behavior, as assessed by activity trackerPre-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-post intervention changes in irisin concentrationsPre-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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026