NCT02638155

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 23, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2016

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

December 3, 2015

Last Update Submit

March 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (14)

  • Ghrelin

    collected via IV catheter over approximately 3 1/2 hours on one day

  • Peptide YY

    collected via IV catheter over approximately 3 1/2 hours on one day

  • GLP-1

    collected via IV catheter over approximately 3 1/2 hours on one day

  • Insulin

    collected via IV catheter over approximately 3 1/2 hours on one day

  • Glucose

    collected via IV catheter over approximately 3 1/2 hours on one day

  • +9 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

men and women 18-65 who are able to come to TTU for testing and meet eligibility criteria

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TTU College of Human Sciences

Lubbock, Texas, 79409, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

Study Officials

  • Cynthia Dsauza, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 3, 2015

First Posted

December 23, 2015

Study Start

August 1, 2016

Primary Completion

November 11, 2016

Study Completion

November 11, 2016

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations