Skip to main content
OpenTrials
Completed

NCT Number: NCT05382702

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ohio University

Athens, Ohio, 45701, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Subjective Rating of Fear

    Time frame: -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 (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.

  2. Difference in Average Skin Conductance

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

    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.

  3. Gastrointestinal Distress

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

    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.

  4. Cholecystokinin Response

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

    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.

  5. Peptide YY Response

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

    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.

  6. Subjective Rating of Fullness

    Time frame: 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 (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.

  7. Urges to Restrict Food Intake

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 19, 2022
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.