Food Addiction and Hormone Study

Disordered Eating Clinical Trial

Official title:

Food Addition and Hormone Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02638155
• Other study ID #: 505490
• Status: Recruiting
• Phase: N/A
• First received: December 3, 2015
• Last updated: October 18, 2016
• Start date: August 2016
• Est. completion date: December 2016

Study information

• Verified date: October 2016
• Source: Texas Tech University
• Contact: Cynthia DSauza, PhD
• Email: cmdsauza[@]ttu.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disordered Eating

Locations

Country	Name	City	State
United States	TTU College of Human Sciences	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrogastrography (EGG) using Bipoac Systems EGG machine	Skin electrode similar to EKG attached to abdomen and readings taken	the participant will be tested continuously for approximately 3 1/2 hours on 1 day, readings are collected on a PC	No
Secondary	Ghrelin	hormone assay	collected via IV catheter over approximately 3 1/2 hours on one day	No
Secondary	Peptide YY	hormone assay	collected via IV catheter over approximately 3 1/2 hours on one day	No
Secondary	GLP-1	hormone assay	collected via IV catheter over approximately 3 1/2 hours on one day	No
Secondary	Insulin	hormone assay	collected via IV catheter over approximately 3 1/2 hours on one day	No
Secondary	Glucose	Blood glucose levels	collected via IV catheter over approximately 3 1/2 hours on one day	No
Secondary	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.	Day 1-5-10 minutes	No
Secondary	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.	Day 1 5-10 minutes	No
Secondary	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.	Day 1 5-10 minutes	No
Secondary	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	Day 1 5-10 minutes	No
Secondary	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.	Day 1 5-10 minutes	No
Secondary	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.	Day 1 5-10 minutes	No
Secondary	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.	Day 1 5-10 minutes	No
Secondary	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.	Day 1 5-10 minutes	No
Secondary	Resting Metabolic Rate	participant breathes into mouthpiece of handheld device for 10 minutes	10 min	No