Back to resultsFear, Gastrointestinal Distress, and Interoception: Physiological and Psychological Mechanisms in Eating Disorders
Primary Purpose
Feeding and Eating Disorders
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Test meal description changed
Sponsored by
About this trial
This is an interventional basic science trial for Feeding and Eating Disorders
Eligibility Criteria
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 condition or medication that affect appetite or weight (excluding hormonal contraceptives and stable dose (e.g., 8 weeks) of a selective serotonin re-uptake inhibitor)
- Recent pregnancy or current breastfeeding
- Dairy, strawberry or honey food allergy
- Specific phobia, blood-injection-injury type
Sites / Locations
- Ohio UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
High Fat Yogurt - Low Fat Yogurt
Low Fat Yogurt - High Fat Yogurt
Arm Description
Participants will eat yogurt described as 'high fat' at Study Visit 2 and yogurt described as 'low fat' at Study Visit 3.
Participants will eat yogurt described as 'low fat' at Study Visit 2 and yogurt described as 'high fat' at Study Visit 3.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05382702
First Posted
May 11, 2022
Last Updated
January 26, 2023
Sponsor
Ohio University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05382702
Brief Title
Fear, Gastrointestinal Distress, and Interoception: Physiological and Psychological Mechanisms in Eating Disorders
Official Title
Fear, Gastrointestinal Distress, and Interoception: Physiological and Psychological Mechanisms in Eating Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding and Eating Disorders
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
152 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High Fat Yogurt - Low Fat Yogurt
Arm Type
Other
Arm Description
Participants will eat yogurt described as 'high fat' at Study Visit 2 and yogurt described as 'low fat' at Study Visit 3.
Arm Title
Low Fat Yogurt - High Fat Yogurt
Arm Type
Other
Arm Description
Participants will eat yogurt described as 'low fat' at Study Visit 2 and yogurt described as 'high fat' at Study Visit 3.
Intervention Type
Other
Intervention Name(s)
Test meal description changed
Intervention Description
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 Outcome Measure Information:
Title
Subjective rating of fear
Description
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.
Time Frame
-10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention
Title
Skin conductance
Description
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.
Time Frame
-10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention
Title
Gastrointestinal distress
Description
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.
Time Frame
-10 minutes, 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
Title
Cholecystokinin response
Description
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.
Time Frame
0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
Title
Peptide YY response
Description
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.
Time Frame
0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
Title
Subjective rating of fullness
Description
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.
Time Frame
0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
Title
Urges to restrict food intake
Description
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.
Time Frame
60 minutes post-intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine J Forney, PhD
Phone
740-593-1085
Email
forney@ohio.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine J Forney, PhD
Organizational Affiliation
Ohio University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio University
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine J Forney, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared according to the NIMH Data Sharing Policy (NOT-MH-19-033), including being shared with the NIMH Data Archive.
Learn more about this trial
Fear, Gastrointestinal Distress, and Interoception: Physiological and Psychological Mechanisms in Eating Disorders
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