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Completed

NCT Number: NCT02638155

Food Addiction 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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

TTU College of Human Sciences

Lubbock, Texas, 79409, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Ghrelin

    Time frame: collected via IV catheter over approximately 3 1/2 hours on one day

    hormone assay

  2. Peptide YY

    Time frame: collected via IV catheter over approximately 3 1/2 hours on one day

    hormone assay

  3. GLP-1

    Time frame: collected via IV catheter over approximately 3 1/2 hours on one day

    hormone assay

  4. Insulin

    Time frame: collected via IV catheter over approximately 3 1/2 hours on one day

    hormone assay

  5. Glucose

    Time frame: collected via IV catheter over approximately 3 1/2 hours on one day

    Blood glucose levels

  6. The Center for Epidemiologic Studies Depression Scale

    Time frame: Day 1-5-10 minutes

    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.

  7. GAD-7

    Time frame: Day 1 5-10 minutes

    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.

  8. Yale Food Addiction Scale 2.0

    Time frame: Day 1 5-10 minutes

    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.

  9. Power of Food Scale

    Time frame: Day 1 5-10 minutes

    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

  10. Multidimensional Body-Self Relations Questionnaire - Appearance Scales

    Time frame: Day 1 5-10 minutes

    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.

  11. Trait and State Food Cravings Questionnaires

    Time frame: Day 1 5-10 minutes

    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.

  12. Food Preoccupation Questionnaire

    Time frame: Day 1 5-10 minutes

    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.

  13. Automated Self-Administered (ASA) 24 Hour Recall

    Time frame: Day 1 5-10 minutes

    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.

  14. Resting Metabolic Rate

    Time frame: 10 min

    participant breathes into mouthpiece of handheld device for 10 minutes

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Registry information

Official study title

Food Addition and Hormone Study

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2015
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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