Fear, Gastrointestinal Distress, and Interoception: Physiological and Psychological Mechanisms in Eating Disorders

Ohio University

Status: Enrolling

Conditions: Feeding and Eating Disorders

Treatments: Other: Test meal description changed

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05382702

21-F-14

R15MH128703 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance.

Enrollment: 152 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female
• DSM-5 eating disorder
• score 16 or higher on the Clinical Impairment Assessment
• experience nausea or stomachache after eating at least "sometimes"
• 18 to 40 years old
• body mass index between 18.5 and 26.5 kg/m2

Exclusion criteria

• medical conditions affect appetite or weight
• Recent pregnancy or current breastfeeding
• Dairy, strawberry or honey food allergy
• Specific phobia, blood-injection-injury type

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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152 participants in 2 patient groups

High Fat Yogurt - Low Fat Yogurt

Other group

Description:

Participants will eat yogurt described as 'high fat' at Study Visit 2 and yogurt described as 'low fat' at Study Visit 3.

Treatment:

Other: Test meal description changed

Low Fat Yogurt - High Fat Yogurt

Other group

Description:

Participants will eat yogurt described as 'low fat' at Study Visit 2 and yogurt described as 'high fat' at Study Visit 3.

Treatment:

Other: Test meal description changed