NCT05649189

Brief Summary

The purpose of this descriptive study is to examine telomere length between two groups of people, those with and those without food addiction and identify possible relationships that may play a role in food addiction, it's behaviors and consequences. Research subjects would be adults age 19-70. They would be recruited from the Rural Nebraska Panhandle population. All COVID precautions will be enforced. Human subjects safety plans will be in place for this study.Eligibility: YaleFAS-2 Food Addiction Scale will be used to screen for presence or absence of food addiction. AT a later time, Eligible persons will be given the research consent form to read through and determine if they want to become a participant. If so, they will be consented. The participants will then be assigned an identification number to maintain confidentiality. Intervention: Participants will be given a Oragene saliva DNA collection kit to use and return to investigators. Evaluation:The Oragene saliva DNA collection kit will then be sent in for telomere length testing. Telomere Results will be correlated with food addiction diagnoses and behaviors to identify potential relationships. Follow up: Publication of results

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

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

Study Start

First participant enrolled

October 17, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

December 3, 2022

Last Update Submit

January 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • telomere length

    cross sectional saliva sample from which telomere length is measured

    at baseline only

Study Arms (2)

Participants testing positive for Food Addiction (FA)

these participants have tested positive for Food Addiction (FA) at a severe level using the YaleFAS-2 Food Addiction Scale.

Diagnostic Test: telomere length measure

Participants testing negative for Food Addiction (FA)

these participants have tested negative for Addiction (FA) using the YaleFAS-2 Food Addiction Scale.

Diagnostic Test: telomere length measure

Interventions

length of telomere between two groups

Participants testing negative for Food Addiction (FA)Participants testing positive for Food Addiction (FA)

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All those enrolled (n = 120) were adults (age 19-70) with overweight/obesity (BMI ≥ 25). Half were positive for severe FA (≥ 6 symptoms plus clinical significance) and half were negative for FA (≤ 1 symptom and no clinical significance). These criteria were selected to best define the FA+ and FA- subtypes (Aguirre et al., 2022). Most participants were female (87.5%) and Caucasian (65%). The remainder were Latino (24%), African American (7%), Asian (4%), or Native American (2%). Reported health conditions include diabetes (n = 5), hypertension (n = 20), smoking (n = 4).

You may qualify if:

  • Obese Food addicted persons between ages 19 and 70
  • Obese Non Food addicted persons between ages 19 and 70

You may not qualify if:

  • persons with active liver disease
  • persons with active cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center, College of Nursing

Scottsbluff, Nebraska, 69361, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Conditions

Food Addiction

Condition Hierarchy (Ancestors)

Behavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorFeeding and Eating DisordersMental Disorders

Study Officials

  • Trina M Aguirre, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2022

First Posted

December 13, 2022

Study Start

October 17, 2021

Primary Completion

March 15, 2022

Study Completion

March 15, 2022

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Group data will be shared via publication.Genetic data will not be shared with individuals or other researchers.

Locations