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Exercise and Weight Control

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ClinicalTrials.gov Identifier: NCT02152501
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
James Roemmich, USDA Grand Forks Human Nutrition Research Center

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.

Condition or disease Intervention/treatment Phase
Overweight Obese Other: Exercise Energy Expenditure 300 kcal/day Other: Exercise Energy Expenditure 600 kcal/day Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Exercise and Weight Control: A Search for Biological and Neurobehavioral Compensatory Mechanisms That Defend Against Exercise-Induced Negative Energy Balance
Actual Study Start Date : April 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152501


Locations
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United States, North Dakota
USDA Grand Forks Human Nutrition Reserach Center
Grand Forks, North Dakota, United States, 58203
Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
Investigators
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Principal Investigator: James Roemmich, PhD USDA GFHNRC

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Responsible Party: James Roemmich, PhD, Research Leader, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT02152501     History of Changes
Other Study ID Numbers: GFHNRC028
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by James Roemmich, USDA Grand Forks Human Nutrition Research Center:
obese
overweight
exercise
energy expenditure differences
relative reinforcing values (RRV)
food
physical activity
biological
neurobehavioral
behavioral
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms