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Effects of Exercise Intensity on Energy Intake, Appetite and Enjoyment in Overweight and Obese Females

Primary Purpose

Overweight and Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional basic science trial for Overweight and Obesity

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Female
Adult
apparently healthy
overweight or class I obese
eumenorrheic

Exclusion Criteria:

Diabetes
pregnancy
cardiovascular disease
greater than 1 hour of structured physical activity per week
thyroid disease
polycystic ovary disease

Sites / Locations

Human Physiology Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

high-intensity

low-intensity

Arm Description

Outcomes

Primary Outcome Measures

Change in energy expenditure

caloric expenditure measured via indirect calorimetry

Change in energy intake

measured via standardized lunch

Change in appetite

measured via circulating hormones leptin and acylated ghrelin

Change in subjective hunger

via visual analogue scale 100 mm, higher scores indicate greater hunger

Secondary Outcome Measures

Full Information

NCT ID

NCT04437550

First Posted

June 15, 2020

Last Updated

June 16, 2020

Sponsor

Ohio University

Collaborators

Marywood University

1. Study Identification

Unique Protocol Identification Number

NCT04437550

Brief Title

Effects of Exercise Intensity on Energy Intake, Appetite and Enjoyment in Overweight and Obese Females

Official Title

Effects of Exercise Intensity on Energy Intake, Appetite and Enjoyment in Overweight and Obese Females

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio University

Collaborators

Marywood University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Interval exercise involves short bouts of high intensity exercise interspersed with periods of lower intensity exercise. The benefit is that a shorter total duration of exercise may be required to achieve cardiovascular benefits similar to or even superior to traditional longer bouts of steady state endurance exercise. However how this type of exercise affects appetite and energy intake, particularly in overweight and obese females is not well known. This study involves two trials of exercise, one at high intensity and one at low intensity, followed by a buffet lunch, in overweight and obese females.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

high-intensity

Arm Type

Experimental

Arm Title

low-intensity

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Exercise

Intervention Description

high intensity exercise = 15 x 60 s sprints at 85% velocity of VO2max (vVO2max) with 60 s walking at 20% vVO2max or moderate intensity exercise = walking at 60% vVO2max

Primary Outcome Measure Information:

Title

Change in energy expenditure

Description

caloric expenditure measured via indirect calorimetry

Time Frame

immediately pre-breakfast, immediately pre-exercise, during exercise, and immediately post-exercise.

Title

Change in energy intake

Description

measured via standardized lunch

Time Frame

immediately post exercise

Title

Change in appetite

Description

measured via circulating hormones leptin and acylated ghrelin

Time Frame

immediately pre-breakfast, immediately post-breakfast, immediately post-exercise and immediately pre-lunch

Title

Change in subjective hunger

Description

via visual analogue scale 100 mm, higher scores indicate greater hunger

Time Frame

baseline, immediately pre-exercise, immediately post-exercise, immediately pre-lunch, and immediately post-lunch

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female Adult apparently healthy overweight or class I obese eumenorrheic Exclusion Criteria: Diabetes pregnancy cardiovascular disease greater than 1 hour of structured physical activity per week thyroid disease polycystic ovary disease

Facility Information:

Facility Name

Human Physiology Lab

City

Scranton

State/Province

Pennsylvania

ZIP/Postal Code

18509

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Effects of Exercise Intensity on Energy Intake, Appetite and Enjoyment in Overweight and Obese Females

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