Clinical trial NCT02638155: Food Addiction and Hormone Study
Official title: Food Addition and Hormone Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disordered Eating
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2015-12-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Electrogastrography (EGG) using Bipoac Systems EGG machine
timeFrame: the participant will be tested continuously for approximately 3 1/2 hours on 1 day, readings are collected on a PC
Secondary outcomes:
measure: Ghrelin
timeFrame: collected via IV catheter over approximately 3 1/2 hours on one day
measure: Peptide YY
timeFrame: collected via IV catheter over approximately 3 1/2 hours on one day
measure: GLP-1
timeFrame: collected via IV catheter over approximately 3 1/2 hours on one day
measure: Insulin
timeFrame: collected via IV catheter over approximately 3 1/2 hours on one day
measure: Glucose
timeFrame: collected via IV catheter over approximately 3 1/2 hours on one day
measure: The Center for Epidemiologic Studies Depression Scale
timeFrame: Day 1-5-10 minutes
measure: GAD-7
timeFrame: Day 1 5-10 minutes
measure: Yale Food Addiction Scale 2.0
timeFrame: Day 1 5-10 minutes
measure: Power of Food Scale
timeFrame: Day 1 5-10 minutes
measure: Multidimensional Body-Self Relations Questionnaire - Appearance Scales
timeFrame: Day 1 5-10 minutes
measure: Trait and State Food Cravings Questionnaires
timeFrame: Day 1 5-10 minutes
measure: Food Preoccupation Questionnaire
timeFrame: Day 1 5-10 minutes
measure: Automated Self-Administered (ASA) 24 Hour Recall
timeFrame: Day 1 5-10 minutes
measure: Resting Metabolic Rate
timeFrame: 10 min
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: TTU College of Human Sciences
state: Texas
Study officials:
affiliation: Assistant Professor
name: Cynthia Dsauza, PhD
role: PRINCIPAL_INVESTIGATOR
References: