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

Feeding and Eating Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05382702
• Other study ID #: 21-F-14
• Secondary ID: R15MH128703
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Ohio University
• Contact: Katherine J Forney, PhD
• Phone: 740-593-1085
• Email: forney[@]ohio.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Feeding and Eating Disorders

Intervention

Other:
• Test meal description changed
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.

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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" to "Extreme." Subjective fear immediately before the meal will be used in mediation models.	-10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention
Primary	Skin conductance	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.	-10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention
Primary	Gastrointestinal distress	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.	-10 minutes, 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
Primary	Cholecystokinin response	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.	0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
Primary	Peptide YY response	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.	0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
Primary	Subjective rating of fullness	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.	0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
Primary	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