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Food Addiction and Hormone Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638155
Recruitment Status : Unknown
Verified October 2016 by Cynthia Dsauza, Texas Tech University.
Recruitment status was:  Recruiting
First Posted : December 23, 2015
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Cynthia Dsauza, Texas Tech University

Study Description
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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
Disordered Eating

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
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Food Addition and Hormone Study
Study Start Date : August 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638155


Contacts
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Contact: Cynthia DSauza, PhD cmdsauza@ttu.edu
Contact: Allison Childress, MS allison.childress@ttu.edu

Locations
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United States, Texas
TTU College of Human Sciences Recruiting
Lubbock, Texas, United States, 79409
Contact: Allison Childress    806-834-6371    allison.childress@ttu.edu   
Contact: Cynthia Dsauza    8067437335      
Sponsors and Collaborators
Texas Tech University
Investigators
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Principal Investigator: Cynthia Dsauza, PhD Assistant Professor
More Information
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Responsible Party: Cynthia Dsauza, Assistant Professor, Texas Tech University
ClinicalTrials.gov Identifier: NCT02638155    
Other Study ID Numbers: 505490
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No