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

NCT05382702 | Completed Results

• 2 other identifiers: 21-F-14R15MH128703
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Feeding and Eating Disorders

Outcome Measures

Primary Outcomes (7)

• Subjective Rating of Fear

  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 (0)" to "Extreme (100)." AUCi was calculated as: (((Fear at -10 minutes)+ (Fear at 0 minutes))\*10/2) + (((Fear at 0 Minutes)+(Fear at +10 minutes))\*10/2) - (Fear at -10 minutes)\*20. A more positive score indicates greater increases in fear over the pre to post meal period.

  -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention

• Difference in Average Skin Conductance

  Skin conductance data will be collected in microsiemens using a Biopac Bionomadix EDA System during the period before and after the test meal. The difference in average microsiemens will be computed for each test meal using the following equation: (Average activity for the 10 minute meal period) - (average activity for the 10 minutes prior to the meal). A higher difference indicates increased physiological activation during the meal period relative to the pre-meal period.

  -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention

• Gastrointestinal Distress

  Gastrointestinal distress will be the averaged visual analogue scale ratings of "Nausea" and "Stomach Ache" ranging from "Not At All (0)" to "Extreme (100)." 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. AUCi was calculated as: (((Gastrointestinal distress at -10 minutes)+ (Gastrointestinal distress at 0 minutes))\*10/2) + (((Gastrointestinal distress at 0 Minutes)+(Gastrointestinal distress at +10 minutes))\*10/2) - (Gastrointestinal distress at -10 minutes)\*20. A more positive score indicates greater increases in gastrointestinal distress over the pre to post meal period.

  -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention

• Cholecystokinin Response

  Blood was drawn repeatedly. Cholecystokinin (CCK) values in plasma were quantified in ng/mL using a commercially available enzyme immunoassay (Phoenix Pharmaceuticals EK-069-02). Area under the curve with respect to increase (AUCi) was calculated from the time period immediately before the test meal to 90 minutes after the test meal. AUCi was calculated as: (((CCK at 0 Minutes)+( CCK at +10 minutes))\*10/2) + (((CCK at 10 Minutes)+( CCK at +20 minutes))\*10/2) + (((CCK at 20 Minutes)+( CCK at +30 minutes))\*10/2) + (((CCK at 30 Minutes)+( CCK at +60 minutes))\*30/2) + (((CCK at+ 60 Minutes)+( CCK at +90 minutes))\*30/2) - (CCK at -10 minutes)\*90. A more positive score indicates greater increases in CCK over the pre to post meal period.

  0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention

• Peptide YY Response

  Blood was drawn repeatedly. Peptide YY (PYY) values in plasma were quantified in ng/mL using a commercially available enzyme immunoassay (Phoenix Pharmaceuticals EK-059-02). Area under the curve with respect to increase (AUCi) was calculated from the time period immediately before the test meal to 90 minutes after the test meal. AUCi was calculated as: (((PYY at 0 Minutes)+( PYY at +10 minutes))\*10/2) + (((PYY at 10 Minutes)+(PYY at +20 minutes))\*10/2) + (((PYY at 20 Minutes)+( PYY at +30 minutes))\*10/2) + (((PYY at 30 Minutes)+( PYY at +60 minutes))\*30/2) + (((PYY at+ 60 Minutes)+( PYY at +90 minutes))\*30/2) - (PYY at -10 minutes)\*90. A more positive score indicates greater increases in PYY over the pre to post meal period.

  0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention

• Subjective Rating of Fullness

  Fullness will be the averaged visual analogue scale ratings of "full" and "satiated(satisfied)" ranging from "Not At All (0)" to "Extreme (100)." 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. AUCi was calculated as: (((Fullness at -10 minutes)+ (Fullness at 0 minutes))\*10/2) + (((Fullness at 0 Minutes)+( Fullness at +10 minutes))\*10/2) + (((Fullness at 10 Minutes)+( Fullness at +20 minutes))\*10/2) + (((Fullness at 20 Minutes)+( Fullness at +30 minutes))\*10/2) + (((Fullness at 30 Minutes)+( Fullness at +60 minutes))\*30/2) + (((Fullness at 60 Minutes)+( Fullness at +90 minutes))\*30/2) - (Fullness at -10 minutes)\*100. A more positive score indicates greater increases in fullness over the pre to post meal period.

  0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention

• Urges to Restrict Food Intake

  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.

  60 minutes post-intervention

Study Arms (2)

High Fat Yogurt - Low Fat Yogurt

OTHER

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

Other: Test meal description changed

Low Fat Yogurt - High Fat Yogurt

OTHER

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

Other: Test meal description changed

Interventions

Test meal description changed OTHER

Using a within-subjects crossover design, on two separate mornings participants will eat yogurt described as 'high fat' and 'low fat.' In actuality, the meals will not differ.

High Fat Yogurt - Low Fat Yogurt; Low Fat Yogurt - High Fat Yogurt

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jean Forney
• Organization: Ohio University

forney@ohio.edu

740-593-1085

Study Officials

• Katherine J Forney, PhD

  Ohio University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 19, 2022
• Study Start: April 22, 2022
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: April 15, 2026
• Results First Posted: April 15, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)