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

Not Applicable

Recruiting

• Conditions: Feeding and Eating Disorders
• Interventions: Other: Test meal description changed

• Registration Number: NCT05382702
• Lead Sponsor: Ohio University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-22
• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Fat Yogurt - Low Fat Yogurt	Test meal description changed	Participants will eat yogurt described as 'high fat' at Study Visit 2 and yogurt described as 'low fat' at Study Visit 3.
Low Fat Yogurt - High Fat Yogurt	Test meal description changed	Participants will eat yogurt described as 'low fat' at Study Visit 2 and yogurt described as 'high fat' at Study Visit 3.

Primary Outcome Measures

Name	Time	Method
Subjective rating of fullness	0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention	Fullness will be the averaged visual analogue scale ratings of "full" and "satiated(satisfied)" ranging from "Not At All" to "Extreme." Area under the curve with respect to increase (AUCi) will be used to characterize changes in fullness from immediately before the test meal to 90 minutes after. The 10-minute assessment of fullness will be used in testing fullness as a mediator of the relationship between fear and gastrointestinal distress and the 20 minute assessment will be used for the exploratory serial mediation model.
Peptide YY response	0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention	Blood will be drawn repeatedly. PYY3-36 values in plasma will be quantified using a commercially available enzyme immunoassay. Area under the curve with respect to increase (AUCi) will be calculated for all time periods to compare between test meal instructions. PYY values 10 minutes after the intervention will be used in mediation models.
Skin conductance	-10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention	Skin conductance data will be collected using a Biopac Bionomadix EDA System. Difference scores will be computed for both test meals by comparing mean skin conductance level (expressed in log units) over the 10 minute meal period to the 10 minute period before the meal.
Subjective rating of fear	-10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention	Area under the curve with respect to increase (AUCi) from the 10 minutes period prior to the meal until immediately after the meal will be used to characterize changes in Visual Analogue Scale ratings of momentary fear ranging from "Not at All" to "Extreme." Subjective fear immediately before the meal will be used in mediation models.
Gastrointestinal distress	-10 minutes, 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention	Gastrointestinal distress will be the averaged visual analogue scale ratings of "Nausea" and "Stomach Ache" ranging from "Not At All" to "Extreme." Area under the curve with respect to increase (AUCi) from the 10 minutes period prior to the meal until immediately after the meal will be used to characterize changes gastrointestinal distress. The 20-minute assessment of gastrointestinal distress will be used for the hypothesis testing mediators of the relationship between fear and gastrointestinal distress and the 30 minute assessment will be used for the exploratory serial multiple mediation model.
Cholecystokinin response	0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention	Blood will be drawn repeatedly. Cholecystokinin (CCK) values in plasma will be quantified using a commercially available enzyme immunoassay. Area under the curve with respect to increase (AUCi) will be calculated for all time periods to compare between test meal instructions. CCK values 10 minutes after the intervention will be used in mediation models.
Urges to restrict food intake	60 minutes post-intervention	Visual analogue scales will assess momentary "urge to restrict" from "Not At All" (0) to "Extreme" (100). The 60 minute assessment will be used for the exploratory serial mediation model.

Trial Locations

Locations (1)

Ohio University; 🇺🇸 Athens, Ohio, United States