Relationships Between Exercise and Appetite in Women With Loss of Control Eating

NCT06602973 | Completed

• 1 other identifier: IRB_FY24-403
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

exercise; eating disorders

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  30 minutes, pre-post exercise (or rest)

• Acylated ghrelin

  Immediately prior to lunch

• Self-reported binge eating

  24 and 48 hours after exercise/rest study visit

• Food reward value

  Approximately 3:30 pm day of study visit

Study Arms (6)

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.

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.

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.

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).

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)

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.

Behavioral: Rest; Behavioral: Fed Exercise; Behavioral: Fasted Exercise

Interventions

Rest BEHAVIORAL

Participants will eat breakfast but abstain from exercise

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 Exercise BEHAVIORAL

Participants will eat breakfast and engage in 30 minutes of physical activity at 75% of their personal V02max.

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 Exercise BEHAVIORAL

Participants will engage in 30 minutes of physical activity at their personal 75% V02max after abstaining from breakfast.

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio University: lead

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa; Motor Activity

Interventions

RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: August 30, 2024
• Primary Completion: April 21, 2026
• Study Completion: April 21, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)