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
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Observational Model:||Case Control|
|Official Title:||Food Addition and Hormone Study|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||December 2016|
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
- 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
- Ghrelin [ Time Frame: collected via IV catheter over approximately 3 1/2 hours on one day ]hormone assay
- Peptide YY [ Time Frame: collected via IV catheter over approximately 3 1/2 hours on one day ]hormone assay
- GLP-1 [ Time Frame: collected via IV catheter over approximately 3 1/2 hours on one day ]hormone assay
- Insulin [ Time Frame: collected via IV catheter over approximately 3 1/2 hours on one day ]hormone assay
- Glucose [ Time Frame: collected via IV catheter over approximately 3 1/2 hours on one day ]Blood glucose levels
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- Resting Metabolic Rate [ Time Frame: 10 min ]participant breathes into mouthpiece of handheld device for 10 minutes
Biospecimen Retention: Samples With DNA
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
|Contact: Cynthia DSauza, PhDfirstname.lastname@example.org|
|Contact: Allison Childress, MSemail@example.com|
|United States, Texas|
|TTU College of Human Sciences||Recruiting|
|Lubbock, Texas, United States, 79409|
|Contact: Allison Childress 806-834-6371 firstname.lastname@example.org|
|Contact: Cynthia Dsauza 8067437335|
|Principal Investigator:||Cynthia Dsauza, PhD||Assistant Professor|