Exercise and Weight Control

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152501
• Other study ID #: GFHNRC028
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: January 2017

Study information

• Verified date: July 2019
• Source: USDA Grand Forks Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Obese
• Overweight

Intervention

Other:
• Exercise Energy Expenditure 300 kcal/day

• Exercise Energy Expenditure 600 kcal/day

Locations

Country	Name	City	State
United States	USDA Grand Forks Human Nutrition Reserach Center	Grand Forks	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
USDA Grand Forks Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	End Training (weeks 10-12)
Secondary	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.	Pre-intervention (week 0) and End Training (weeks 10-12)
Secondary	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).	Pre-intervention (week 0) and End Training (weeks 10-12)
Secondary	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).	Pre-intervention (week 0) and End Training (weeks 10-12)
Secondary	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.	Pre-intervention (week 0) and End Training (weeks 10-12)
Secondary	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.	Pre-intervention (week 0) and End Training (weeks 10-12)
Secondary	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.	Pre-intervention (week 0) and End Training (weeks 10-12)
Secondary	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.	Pre-intervention (week 0) and End Training (weeks 10-12)
Secondary	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.	Pre-intervention (week 0) and End Training (weeks 10-12)
Secondary	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.	Pre-intervention (week 0) and End Training (weeks 10-12)