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Completed

NCT Number: NCT02152501

Exercise and Weight Control

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.

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Key information

Conditions

Overweight Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA Grand Forks Human Nutrition Reserach Center

Grand Forks, North Dakota, 58203, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Energy Expenditure 300 kcal/day

Other

Exercise Energy Expenditure 600 kcal/day

Other

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

USDA Grand Forks Human Nutrition Research Center

Fed

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jun 2, 2014
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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