- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02638155
Food Addiction and Hormone Study
March 26, 2026 updated by: Cynthia Jefferson, Texas Tech University
Food Addition and Hormone Study
The purpose of this exploratory study is to use Electrogastrography (EGG) to measure and compare the gastric myoelectrical activity between persons with food addiction (FA) and a control group.
Additionally, this study will explore if differences exist between perceived hunger and satiety and hormone levels related to hunger and satiety in both groups.
The comparison of the EGG readings and hormone levels is the next step in furthering our understanding of food addiction and how the physiology - not simply the symptomatology - of FA does or does not relate to weight management.
Study Overview
Status
Completed
Conditions
Detailed Description
The study will be conducted over 2 days and will consist of psychological assessments as well as EGG measurement (similar to EGG) and blood draws to examine hunger and satiety hormones.
Study Type
Observational
Enrollment (Actual)
23
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Lubbock, Texas, United States, 79409
- TTU College of Human Sciences
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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
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
men and women 18-65 who are able to come to TTU for testing and meet eligibility criteria
Description
Inclusion Criteria:
- Participants will include men and women who identify with weight struggles related to disordered eating and a control sample of people who do not identify with weight issues or disordered eating. Must be able to read and write English
Exclusion Criteria:
- Anyone with a chronic disease including type II diabetes, hypothyroidism, hypoparathyroidism, cardiovascular disease, cancer of any type
- Anyone who is currently pregnant, or lactating
- Medications that may influence or inhibit appetite, sensory functioning, or hormone signaling- e.g. antibiotics, anti-depressants, obesity medications
- Report of medical condition or surgical intervention that affects swallowing ability
- Allergy, aversion, or dislike to any of the meal replacements or snacks offered
- Previous or current diagnosis of a psychiatric illness such as schizophrenia or any other psychotic disorder listed in the DSM-IV or DSM-5
- Report of medical conditions that prohibits overnight fasting
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
Cohorts and Interventions
Group / Cohort |
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Food Addiction Group
Those participants identified as having food addiction by the Yale Food Addiction Scale.
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No Food Addiction Group
Those participants with no identified food addiction
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Electrogastrography (EGG) using Bipoac Systems EGG machine
Time Frame: the participant will be tested continuously for approximately 3 1/2 hours on 1 day, readings are collected on a PC
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Skin electrode similar to EKG attached to abdomen and readings taken
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the participant will be tested continuously for approximately 3 1/2 hours on 1 day, readings are collected on a PC
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ghrelin
Time Frame: collected via IV catheter over approximately 3 1/2 hours on one day
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hormone assay
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collected via IV catheter over approximately 3 1/2 hours on one day
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Peptide YY
Time Frame: collected via IV catheter over approximately 3 1/2 hours on one day
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hormone assay
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collected via IV catheter over approximately 3 1/2 hours on one day
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GLP-1
Time Frame: collected via IV catheter over approximately 3 1/2 hours on one day
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hormone assay
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collected via IV catheter over approximately 3 1/2 hours on one day
|
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Insulin
Time Frame: collected via IV catheter over approximately 3 1/2 hours on one day
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hormone assay
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collected via IV catheter over approximately 3 1/2 hours on one day
|
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Glucose
Time Frame: collected via IV catheter over approximately 3 1/2 hours on one day
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Blood glucose levels
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collected via IV catheter over approximately 3 1/2 hours on one day
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The Center for Epidemiologic Studies Depression Scale
Time Frame: Day 1-5-10 minutes
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Depression will be measured using The Center for Epidemiologic Studies Depression Scale Revised , a 20-item measure of depression that measures nine different symptom groups of depression according to the American Psychiatric Association Diagnostic and Statistical Manual, fourth edition.
These symptom groups include Sadness, Loss of Interest, Appetite, Sleep, Thinking/Concentration, Guilt, Tired, Movement, and Suicidal Ideation.
Responses regard frequency of symptoms and are given on 5-point Likert-type scale ranging from 0 (Not at all or less than one day) to 4 (Nearly every day for two weeks).
Sample items include "My appetite was poor" and "Nothing made me happy."
Item responses are summed to calculate a total score of depression that can be used to classify depression severity.
This assessment will take approximately 5-10 minutes.
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Day 1-5-10 minutes
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GAD-7
Time Frame: Day 1 5-10 minutes
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Anxiety will be measured using the GAD-7 measure used to assess for generalized anxiety disorder and will take less than 5 minutes to complete.
The GAD-7 measures anxiety using seven items to assess frequency of anxiety symptoms on which responses are given on a 4-point Likert-type scale ranging from 0 (Not at all) to 3 (Nearly every day).
Sample items include "Feeling anxious, nervous, or on edge" and "Becoming easily annoyed or irritable."
All items are summed; and higher scores represent higher levels of anxiety and can be used to classify anxiety severity.
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Day 1 5-10 minutes
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Yale Food Addiction Scale 2.0
Time Frame: Day 1 5-10 minutes
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The YFAS is a 35-item measure developed to operationalize food addiction by assessing signs of substance-dependence symptoms (e.g., tolerance, withdrawal, loss of control) in eating behavior.
The YFAS has shown internal consistency, as well as convergent and incremental validity.
The YFAS provides 2 scoring options: a symptom count version and a diagnostic version.
To receive a "diagnosis" of FA, it is necessary to report experiencing 3 or more symptoms in the past year and clinically significant impairment or distress.
The version of the YFAS used in the current study will measure all items on a Likert scale.
In line with YFAS scoring instructions, 5 of the Likert scale items were dichotomized, such that participants who indicated that they had never experienced the symptom were assigned a value of zero, and those reporting ever experiencing the symptom in the past year were assigned a value of 1.
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Day 1 5-10 minutes
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Power of Food Scale
Time Frame: Day 1 5-10 minutes
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The Power of Food Scale (PFS) is a 15-item questionnaire on a 5-point Likert scale ranging from 1 (don't agree) to 5 (strongly agree), and it is designed to measure appetite drive towards highly palatable foods through examining appetite-related thoughts, feelings, and motivations
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Day 1 5-10 minutes
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Multidimensional Body-Self Relations Questionnaire - Appearance Scales
Time Frame: Day 1 5-10 minutes
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The Multidimensional Body-Self Relations Questionnaire - Appearance Scales (MBSRQ-AS) is a 34 item measure on a five point Likert scale that is made up of five subscales: Appearance Evaluation, Appearance Orientation, Overweight Preoccupation, Self-Classified Weight, and the Body Areas Satisfaction Scale.
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Day 1 5-10 minutes
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Trait and State Food Cravings Questionnaires
Time Frame: Day 1 5-10 minutes
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The Trait and State Food Cravings Questionnaire is comprised of two questionnaires that measure state (FCQ-S) and trait (FCQ-T) of food cravings.
The FCQ-S is comprised of 15 items, and the FCQ-T is comprised of 21 items.
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Day 1 5-10 minutes
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Food Preoccupation Questionnaire
Time Frame: Day 1 5-10 minutes
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The Food Preoccupation Questionnaire (FPQ) is a 26 Likert item questionnaire that measures the frequency and emotionality of thoughts related to food.
It is comprised of four subscales: thought frequency as well as positive, negative, and neutral emotional valences.
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Day 1 5-10 minutes
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Automated Self-Administered (ASA) 24 Hour Recall
Time Frame: Day 1 5-10 minutes
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The Automated Self-Administered 24 hour Dietary Recall is a web-based tool that enables automated self-administered 24-hour recalls.
It was developed by the National Cancer Institute and has been used in over 200 research studies with over 45,000 participants.
Response data are secured at the hosting site using industry standard security controls, including firewalls and encryption.
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Day 1 5-10 minutes
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Resting Metabolic Rate
Time Frame: 10 min
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participant breathes into mouthpiece of handheld device for 10 minutes
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10 min
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cynthia Dsauza, PhD, Assistant Professor
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
August 1, 2016
Primary Completion (Actual)
November 11, 2016
Study Completion (Actual)
November 11, 2016
Study Registration Dates
First Submitted
December 3, 2015
First Submitted That Met QC Criteria
December 17, 2015
First Posted (Estimated)
December 23, 2015
Study Record Updates
Last Update Posted (Actual)
April 1, 2026
Last Update Submitted That Met QC Criteria
March 26, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 505490
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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