Eating DisordersNCT06602973
Relationships Between Exercise and Appetite in Women With Loss of Control Eating
A study testing Rest, Fed Exercise and Fasted Exercise in people with Eating Disorders and Binge-Eating Disorder, run by Ohio University at 1 site in United States.
Trial summary
This pilot study is a first step in looking at the relationship between exercise and appetite in women with loss of control eating. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Eating Disorders, Binge-Eating Disorder, Bulimia Nervosa
- What is being tested?
- Rest, Fed Exercise and Fasted Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2024to 21 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study is a first step in looking at the relationship between exercise and appetite in women with loss of control eating.
- Conditions
- Eating Disorders, Binge-Eating Disorder, Bulimia Nervosa
- Being tested
- Rest, Fed Exercise, Fasted Exercise
- Keywords
- exercise, eating disorders
- Medical subject headings
- Feeding and Eating Disorders, Binge-Eating Disorder, Bulimia Nervosa, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestBehavioural
Participants will eat breakfast but abstain from exercise
Fed ExerciseBehavioural
Participants will eat breakfast and engage in 30 minutes of physical activity at 75% of their personal V02max.
Fasted ExerciseBehavioural
Participants will engage in 30 minutes of physical activity at their personal 75% V02max after abstaining from breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Rest, Fed Exercise, Fasted Exercise | Experimental | 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. Receives: Behavioral: Rest; Behavioral: Fed Exercise; Behavioral: Fasted Exercise |
| Rest, Fasted Exercise, Fed Exercise | Experimental | 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. Receives: Behavioral: Rest; Behavioral: Fed Exercise; Behavioral: Fasted Exercise |
| Fed Exercise, Rest, Fasted Exercise | Experimental | 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. Receives: Behavioral: Rest; Behavioral: Fed Exercise; Behavioral: Fasted Exercise |
| Fed Exercise, Fasted Exercise, Rest | Experimental | 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). Receives: Behavioral: Rest; Behavioral: Fed Exercise; Behavioral: Fasted Exercise |
| Fasted Exercise, Fed Exercise, Rest | Experimental | 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) Receives: Behavioral: Rest; Behavioral: Fed Exercise; Behavioral: Fasted Exercise |
| Fasted Exercise, Rest, Fed Exercise | Experimental | 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. Receives: Behavioral: Rest; Behavioral: Fed Exercise; Behavioral: Fasted Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Energy Intake
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).
Measured: 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 outcomes (4)
Lactate
Lactate values
Measured: 30 minutes, pre-post exercise (or rest)
Acylated ghrelin
Acylated ghrelin
Measured: Immediately prior to lunch
Self-reported binge eating
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
Measured: 24 and 48 hours after exercise/rest study visit
Food reward value
Number of trials according to task developed by Bodell and Keel 2015
Measured: Approximately 3:30 pm day of study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Aug 2024
- Primary completion21 Apr 2026
- Study completion21 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine J. Forney, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602973
- Sponsor's protocol ID
- IRB_FY24-403
- Status last verified
- Apr 2026
- First submitted
- 12 Sep 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be shared on a public repository, such as the Open Science Framework
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Between Exercise and Appetite in Women With Loss of Control Eating
- ClinicalTrials.gov ID
- NCT06602973
- Acronym / sponsor ID
- IRB_FY24-403
- Conditions
- Eating Disorders, Binge-Eating Disorder, Bulimia Nervosa
- Keywords
- exercise, eating disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study is a first step in looking at the relationship between exercise and appetite in women with loss of control eating.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Rest, Fed Exercise, Fasted Exercise | Experimental | Behavioral: Rest, Behavioral: Fed Exercise, Behavioral: Fasted ExerciseAt 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. |
| Rest, Fasted Exercise, Fed Exercise | Experimental | Behavioral: Rest, Behavioral: Fed Exercise, Behavioral: Fasted ExerciseAt 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. |
| Fed Exercise, Rest, Fasted Exercise | Experimental | Behavioral: Rest, Behavioral: Fed Exercise, Behavioral: Fasted ExerciseAt 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. |
| Fed Exercise, Fasted Exercise, Rest | Experimental | Behavioral: Rest, Behavioral: Fed Exercise, Behavioral: Fasted ExerciseAt 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). |
| Fasted Exercise, Fed Exercise, Rest | Experimental | Behavioral: Rest, Behavioral: Fed Exercise, Behavioral: Fasted ExerciseAt 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) |
| Fasted Exercise, Rest, Fed Exercise | Experimental | Behavioral: Rest, Behavioral: Fed Exercise, Behavioral: Fasted ExerciseAt 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RestParticipants will eat breakfast but abstain from exercise | Behavioural | Fasted Exercise, Fed Exercise, Rest, Fasted Exercise, Rest, Fed Exercise, Fed Exercise, Fasted Exercise, Rest, Fed Exercise, Rest, Fasted Exercise, Rest, Fasted Exercise, Fed Exercise, Rest, Fed Exercise, Fasted Exercise |
| Fed ExerciseParticipants will eat breakfast and engage in 30 minutes of physical activity at 75% of their personal V02max. | Behavioural | Fasted Exercise, Fed Exercise, Rest, Fasted Exercise, Rest, Fed Exercise, Fed Exercise, Fasted Exercise, Rest, Fed Exercise, Rest, Fasted Exercise, Rest, Fasted Exercise, Fed Exercise, Rest, Fed Exercise, Fasted Exercise |
| Fasted ExerciseParticipants will engage in 30 minutes of physical activity at their personal 75% V02max after abstaining from breakfast. | Behavioural | Fasted Exercise, Fed Exercise, Rest, Fasted Exercise, Rest, Fed Exercise, Fed Exercise, Fasted Exercise, Rest, Fed Exercise, Rest, Fasted Exercise, Rest, Fasted Exercise, Fed Exercise, Rest, Fed Exercise, Fasted Exercise |
Primary outcome
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).
4 secondary outcomes
Lactate
Time frame: 30 minutes, pre-post exercise (or rest)
Acylated ghrelin
Time frame: Immediately prior to lunch
Self-reported binge eating
Time frame: 24 and 48 hours after exercise/rest study visit
Food reward value
Time frame: Approximately 3:30 pm day of study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Undecided. Data may be shared on a public repository, such as the Open Science Framework
Related trials for Eating Disorders
Enrolling by invitationPhase 3
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
Binge-Eating Disorder
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Recruiting
Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa
Bulimia Nervosa, Feeding and Eating Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rest, Fed Exercise and Fasted Exercise in people with Eating Disorders and Binge-Eating Disorder, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.