- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06602973
Relationships Between Exercise and Appetite in Women With Loss of Control Eating
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Athens, Ohio, United States, 45701
- Ohio University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Engage in loss of control eating at least 12 times in the last three months
- Clinically significant eating disorder-related impairment (CIA > 15)
- Minimum VO2max of 50th percentile for age and sex assigned at birth
- Be willing to eat study-provided foods
- Likes chocolate (at least 6/10 on 10 point scale)
Exclusion Criteria:
- BMI < 18.5 kgm/2
- Medical conditions that affect appetite or weight (e.g., diabetes mellitus, thyroid disease)
- Recent pregnancy or breastfeeding (prior 6 months)
- Relevant food allergies (e.g., wheat, chocolate)
- Specific phobia, blood-injection-injury type
- Medical condition that precludes safe participation in exercise (e.g., stress fracture)
- Medications that acutely affect appetite (e.g., GLP-1 agonists; psychiatric medications allowed)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rest, Fed Exercise, Fasted Exercise
At Study Visit 2, participants will eat breakfast and rest (abstain from exercise). At Study Visit 3, participants will eat breakfast and exercise. At Study Visit 4, participants will abstain from breakfast and will engage in exercise. |
Participants will eat breakfast but abstain from exercise
Participants will eat breakfast and engage in 30 minutes of physical activity at 75% of their personal V02max.
Participants will engage in 30 minutes of physical activity at their personal 75% V02max after abstaining from breakfast.
|
|
Experimental: Rest, Fasted Exercise, Fed Exercise
At Study Visit 2, participants will eat breakfast and rest (abstain from exercise). At Study Visit 3, participants will abstain from breakfast and will engage in exercise. At Study Visit 4, participants will eat breakfast and exercise. |
Participants will eat breakfast but abstain from exercise
Participants will eat breakfast and engage in 30 minutes of physical activity at 75% of their personal V02max.
Participants will engage in 30 minutes of physical activity at their personal 75% V02max after abstaining from breakfast.
|
|
Experimental: Fed Exercise, Rest, Fasted Exercise
At Study Visit 2, participants will eat breakfast and exercise. At Study Visit 3, participants will eat breakfast and rest (abstain from exercise). At Study Visit 4, participants will abstain from breakfast and will engage in exercise. |
Participants will eat breakfast but abstain from exercise
Participants will eat breakfast and engage in 30 minutes of physical activity at 75% of their personal V02max.
Participants will engage in 30 minutes of physical activity at their personal 75% V02max after abstaining from breakfast.
|
|
Experimental: Fed Exercise, Fasted Exercise, Rest
At Study Visit 2, participants will eat breakfast and exercise. At Study Visit 3, participants will abstain from breakfast and will engage in exercise. At Study Visit 4, participants will eat breakfast and rest (abstain from exercise). |
Participants will eat breakfast but abstain from exercise
Participants will eat breakfast and engage in 30 minutes of physical activity at 75% of their personal V02max.
Participants will engage in 30 minutes of physical activity at their personal 75% V02max after abstaining from breakfast.
|
|
Experimental: Fasted Exercise, Fed Exercise, Rest
At Study Visit 2, participants will abstain from breakfast and will engage in exercise. At Study Visit 3, participants will eat breakfast and exercise. At Study Visit 4, participants will eat breakfast and rest (abstain from exercise) |
Participants will eat breakfast but abstain from exercise
Participants will eat breakfast and engage in 30 minutes of physical activity at 75% of their personal V02max.
Participants will engage in 30 minutes of physical activity at their personal 75% V02max after abstaining from breakfast.
|
|
Experimental: Fasted Exercise, Rest, Fed Exercise
At Study Visit 2, participants will abstain from breakfast and will engage in exercise. At Study Visit 3, participants will eat breakfast and rest (abstain from exercise). At Study Visit 4, participants will eat breakfast and exercise. |
Participants will eat breakfast but abstain from exercise
Participants will eat breakfast and engage in 30 minutes of physical activity at 75% of their personal V02max.
Participants will engage in 30 minutes of physical activity at their personal 75% V02max after abstaining from breakfast.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relative Energy Intake
Time Frame: Food intake from 8 am to 8 am; Energy expenditure from approximately 9 am to 9:05 am and 9:25 to 9:30 am, coinciding with study condition (rest or exercise)
|
Relative energy intake for 24 hours will be calculated as absolute energy intake from the breakfast (if consumed), lunch, food reward value task, and take home cooler minus energy expenditure during exercise (or comparable time period during rest).
|
Food intake from 8 am to 8 am; Energy expenditure from approximately 9 am to 9:05 am and 9:25 to 9:30 am, coinciding with study condition (rest or exercise)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lactate
Time Frame: 30 minutes, pre-post exercise (or rest)
|
Lactate values
|
30 minutes, pre-post exercise (or rest)
|
|
Acylated ghrelin
Time Frame: Immediately prior to lunch
|
Acylated ghrelin
|
Immediately prior to lunch
|
|
Self-reported binge eating
Time Frame: 24 and 48 hours after exercise/rest study visit
|
Participants will rate the extent the following questions, considering the time frame "since yesterday morning at 8 am" on a 1 to 5 scale from "not at all" to "extremely": "While you were eating, to what extent did you feel a sense of loss of control?," "While you were eating, to what extent did you feel that you could not resist eating," "While you were eating, to what extent did you feel that you could not stop eating once you had started," and "While you were eating, to what extent did you feel driven or compelled to eat?" An answer of 4 or higher on any item will be categorized as binge eating present. Any reported binge eating on either day will be coded as binge eating being present |
24 and 48 hours after exercise/rest study visit
|
|
Food reward value
Time Frame: Approximately 3:30 pm day of study visit
|
Number of trials according to task developed by Bodell and Keel 2015
|
Approximately 3:30 pm day of study visit
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB_FY24-403
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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