- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01645956
Consistency in Individual Differences in Energy Intake Following Acute Exercise
February 18, 2015 updated by: The Miriam Hospital
The importance of exercise for weight control is well documented; however if exercise results in an increase in food intake, the beneficial effect of exercise may not be seen.
This study addresses a gap in the current literature and examines why some people eat more after exercise and why some people eat less and also examines whether these responses are consistent over time.
Participants in this study will be asked to come to our center on 7 different occasions over a 3-4 month period.
The first visit will be an assessment visit where body weight and body composition will be measured, questionnaires will be completed, and an exercise test will be performed.
During the remaining 6 visits (3 pairs of sessions with visits in each pair separated by 48-96 hours) the procedures will be nearly identical.
Upon arrival at our center, participants will consume a meal replacement, complete a series of questionnaires and then either rest or walk on a treadmill for 30 minutes (3 days will be resting and 3 will be exercising).
One hour following the exercise/resting session, individuals will be given access to a buffet of food, unaware that their food intake will be monitored.
All food will be weighed and measured before and after the eating period and the amount of food consumed after each pair of exercise and resting conditions will be compared to one another.
It is hypothesized that the difference in food intake will be consistent across pairs of testing sessions.
Findings from this study will help us to better understand the relationship between exercise and food intake and may ultimately lead to future studies that can address the clinically significant question of why some individuals gain weight and others lose weight when engaging in exercise training programs.
Findings from this study may also help to develop exercise programs that maximize the beneficial effect of exercise on body weight.
Study Overview
Study Type
Observational
Enrollment (Actual)
28
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
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Providence, Rhode Island, United States, 02903
- Weight Control and Diabetes Research Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Relatively sedentary (exercising less than 60 minutes/week over the past 6 months) overweight and obese (BMI: 25.0 to <35.0 kg/m2) women between the ages of 18 and 45.
Description
Inclusion Criteria:
- Age 18-45 years
- BMI between 25.0 and <35.0 kg/m2
- Female
- Sedentary, defined as exercising at a moderate-intensity for less than 60 minutes/week over the past 6 months.
Exclusion Criteria:
- Presence of any condition that would limit one's ability from exercising (i.e., orthopedic limitations)
- Recent weight gain or weight loss (± 10 pounds within the past 6 months)
- Currently enrolled in a weight loss program
- History of heart disease or diabetes
- Currently taking any medication that would alter heart rate (e.g., beta blocker) or metabolism
- Women who are pregnant, planning on becoming pregnant in the next 2 months, or those pregnant within the past 6 months
- Uncontrolled hypertension (currently taking blood pressure medication or having a resting systolic blood pressure ≥140/90 mmHg
- Get an average of <6 hours of sleep/night
- Does not currently eat breakfast regularly
- Known food allergies to test foods or states a disliking or unwillingness to eat more than 25% of the buffet foods.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Single group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
energy intake
Time Frame: 1 hour post exercise/rest
|
1 hour post exercise/rest
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jessica L Unick, PhD, The Miriam Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
July 18, 2012
First Submitted That Met QC Criteria
July 18, 2012
First Posted (Estimate)
July 20, 2012
Study Record Updates
Last Update Posted (Estimate)
February 19, 2015
Last Update Submitted That Met QC Criteria
February 18, 2015
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 400012
- 1R03CA162965-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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