Disordered EatingNCT02638155
Food Addiction and Hormone Study
An observational study of Disordered Eating, run by Texas Tech University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Disordered Eating
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 11 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: men and women 18-65 who are able to come to TTU for testing and meet eligibility criteria
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Disordered Eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Food Addiction Group | Those participants identified as having food addiction by the Yale Food Addiction Scale. | |
| No Food Addiction Group | Those participants with no identified food addiction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrogastrography (EGG) using Bipoac Systems EGG machine
Skin electrode similar to EKG attached to abdomen and readings taken
Measured: the participant will be tested continuously for approximately 3 1/2 hours on 1 day, readings are collected on a PC
Secondary outcomes (14)
Ghrelin
hormone assay
Measured: collected via IV catheter over approximately 3 1/2 hours on one day
Peptide YY
hormone assay
Measured: collected via IV catheter over approximately 3 1/2 hours on one day
GLP-1
hormone assay
Measured: collected via IV catheter over approximately 3 1/2 hours on one day
Insulin
hormone assay
Measured: collected via IV catheter over approximately 3 1/2 hours on one day
Glucose
Blood glucose levels
Measured: collected via IV catheter over approximately 3 1/2 hours on one day
The Center for Epidemiologic Studies Depression Scale
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.
Measured: Day 1-5-10 minutes
GAD-7
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.
Measured: Day 1 5-10 minutes
Yale Food Addiction Scale 2.0
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.
Measured: Day 1 5-10 minutes
Power of Food Scale
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
Measured: Day 1 5-10 minutes
Multidimensional Body-Self Relations Questionnaire - Appearance Scales
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.
Measured: Day 1 5-10 minutes
Trait and State Food Cravings Questionnaires
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.
Measured: Day 1 5-10 minutes
Food Preoccupation Questionnaire
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.
Measured: Day 1 5-10 minutes
Automated Self-Administered (ASA) 24 Hour Recall
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.
Measured: Day 1 5-10 minutes
Resting Metabolic Rate
participant breathes into mouthpiece of handheld device for 10 minutes
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startAug 2016
- Primary completion11 Nov 2016
- Study completion11 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disordered EatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Jefferson, Texas Tech University
- Investigators
- Cynthia Dsauza, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638155
- Sponsor's protocol ID
- 505490
- Status last verified
- Mar 2026
- First submitted
- 3 Dec 2015
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Addition and Hormone Study
- ClinicalTrials.gov ID
- NCT02638155
- Acronym / sponsor ID
- 505490
- Conditions
- Disordered Eating
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 11 Nov 2016 (actual)
- Study completion
- 11 Nov 2016 (actual)
- First posted
- 23 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food Addiction Group | – | –Those participants identified as having food addiction by the Yale Food Addiction Scale. |
| No Food Addiction Group | – | –Those participants with no identified food addiction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- men and women 18-65 who are able to come to TTU for testing and meet eligibility criteria
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Skin electrode similar to EKG attached to abdomen and readings taken
14 secondary outcomes
Ghrelin
Time frame: collected via IV catheter over approximately 3 1/2 hours on one day
Peptide YY
Time frame: collected via IV catheter over approximately 3 1/2 hours on one day
GLP-1
Time frame: collected via IV catheter over approximately 3 1/2 hours on one day
Insulin
Time frame: collected via IV catheter over approximately 3 1/2 hours on one day
Glucose
Time frame: collected via IV catheter over approximately 3 1/2 hours on one day
The Center for Epidemiologic Studies Depression Scale
Time frame: Day 1-5-10 minutes
GAD-7
Time frame: Day 1 5-10 minutes
Yale Food Addiction Scale 2.0
Time frame: Day 1 5-10 minutes
Power of Food Scale
Time frame: Day 1 5-10 minutes
Multidimensional Body-Self Relations Questionnaire - Appearance Scales
Time frame: Day 1 5-10 minutes
Trait and State Food Cravings Questionnaires
Time frame: Day 1 5-10 minutes
Food Preoccupation Questionnaire
Time frame: Day 1 5-10 minutes
Automated Self-Administered (ASA) 24 Hour Recall
Time frame: Day 1 5-10 minutes
Resting Metabolic Rate
Time frame: 10 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Dsauza, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disordered Eating, run by Texas Tech University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.