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

March 26, 2026 updated by: Ohio University
The proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
133

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Katherine J Forney, PhD
  • Phone Number: 740-593-1085
  • Email: forney@ohio.edu

Study Locations

  • United States
    • Ohio
      • Athens, Ohio, United States, 45701
        • Ohio University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: High Fat Yogurt - Low Fat Yogurt
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
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.
Other: Low Fat Yogurt - High Fat Yogurt
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
-10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention
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.
-10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention
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.
-10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention
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.
0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
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.
0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
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.
0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
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.
60 minutes post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine J Forney, PhD, Ohio University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-F-14
  • R15MH128703 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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