Food Addiction and Hormone Study

Sponsor
Texas Tech University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02638155
Collaborator
(none)
30
1
4
7.5

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Food Addition and Hormone Study
    Study Start Date :
    Aug 1, 2016
    Anticipated Primary Completion Date :
    Nov 1, 2016
    Anticipated Study Completion Date :
    Dec 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Electrogastrography (EGG) using Bipoac Systems EGG machine [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 Outcome Measures

    1. Ghrelin [collected via IV catheter over approximately 3 1/2 hours on one day]

      hormone assay

    2. Peptide YY [collected via IV catheter over approximately 3 1/2 hours on one day]

      hormone assay

    3. GLP-1 [collected via IV catheter over approximately 3 1/2 hours on one day]

      hormone assay

    4. Insulin [collected via IV catheter over approximately 3 1/2 hours on one day]

      hormone assay

    5. Glucose [collected via IV catheter over approximately 3 1/2 hours on one day]

      Blood glucose levels

    6. The Center for Epidemiologic Studies Depression Scale [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 [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 [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 [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 [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 [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 [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 [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 [10 min]

      participant breathes into mouthpiece of handheld device for 10 minutes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 TTU College of Human Sciences Lubbock Texas United States 79409

    Sponsors and Collaborators

    • Texas Tech University

    Investigators

    • Principal Investigator: Cynthia Dsauza, PhD, Assistant Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cynthia Dsauza, Assistant Professor, Texas Tech University
    ClinicalTrials.gov Identifier:
    NCT02638155
    Other Study ID Numbers:
    • 505490
    First Posted:
    Dec 23, 2015
    Last Update Posted:
    Oct 19, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Oct 19, 2016