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Exercise for Binge Eating Disorder

N/A

Recruiting

Research Sponsored by Ohio University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Taking hormonal contraception

Minimum VO2max of 50th percentile for age and sex assigned at birth

Must not have

Medical condition that precludes safe participation in exercise (e.g., stress fracture)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately prior to lunch

Awards & highlights

No Placebo-Only Group

Summary

"This trial is the first step in examining how exercise affects appetite in women who struggle with loss of control eating."

Who is the study for?

This trial is for women who experience loss of control eating at least 12 times in the last three months, have a clinically significant eating disorder, meet minimum fitness levels, enjoy chocolate, and are on hormonal contraception. It's not for those underweight, recently pregnant or breastfeeding, with certain phobias or allergies, conditions affecting appetite/weight like diabetes or thyroid disease, or on appetite-affecting meds.

What is being tested?

The study explores how exercise affects appetite in women with uncontrolled eating by comparing their responses to exercising while fed versus fasted and resting without exercise. Participants will eat specific foods provided by the study during this process.

What are the potential side effects?

Since this trial involves common activities such as exercising and resting there may be minimal side effects related to physical activity such as muscle soreness or fatigue. No severe side effects are expected from these interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently using hormonal birth control.

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My fitness level is at least average for my age and sex.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any health issues that prevent me from safely exercising.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relative Energy Intake

Secondary study objectives

Acylated ghrelin

Food reward value

Lactate

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Rest, Fed Exercise, Fasted ExerciseExperimental Treatment3 Interventions

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.

Group II: Rest, Fasted Exercise, Fed ExerciseExperimental Treatment3 Interventions

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.

Group III: Fed Exercise, Rest, Fasted ExerciseExperimental Treatment3 Interventions

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.

Group IV: Fed Exercise, Fasted Exercise, RestExperimental Treatment3 Interventions

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).

Group V: Fasted Exercise, Rest, Fed ExerciseExperimental Treatment3 Interventions

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.

Group VI: Fasted Exercise, Fed Exercise, RestExperimental Treatment3 Interventions

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rest

2016

Completed Phase 1

~1390

Fasted Exercise

2019

N/A

~40