- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05649189
Differences in Length of Telomere in Food Addicted vs Non Food Addicted Persons
A Study of the Differences in Telomere Length Between Patients With and Without Food Addiction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Food Addiction is often accompanied by overweight/obesity and a host of co-morbidities. From previous pilot studies, we have determined it is difficult to treat and behavioral interventions have limited effectiveness. To better understand possible genetic relationships with food addiction, a handful of researchers have begun to examine this proposed relationship. A meta-analysis (Darrow et al., 2016) that reviewed the studies examining the association between psychiatric disorders and telomere length involved 14,827 persons. Additionally, Daubenmier et al. (2012) examined the relationships among stress, eating, and metabolic factors with telomerase activity with 47 overweight/obese women. These studies lead us to seek proof of concept, that there may be a relationship between food addiction and telomere length and to better characterize persons with and without Food Addiction to enable us to develop interventions specific to each group. In this pilot we will attempt to provide additional scientific knowledge to confirm/support or negate the hypothesis that telomere length may be related to/contributing to Food Addiction. Davis (2019) conducted a review of literature involving food addiction and genetics. In the review, it is noted that thus far there has been only one study that has assessed whether genetic determinants of food addiction overlapped with drug addiction. Two loci (rs75038630 and 74902201) met GW-significance. However, neither of those loci has previously been associated with eating behaviors. We will examine telomere length in our pilot to provide additional evidence for this gap in the knowledge.
The liquid saliva sample kit that will be used is the Oragene saliva DNA collection kit. See following for more specific information.A 2 mL sample of liquid saliva will be obtained by participants spitting into the Oragene saliva DNA collection kit (Genotek Inc. Ottawa, ON, Canada) containing 1 mL of DNA stabilizing liquid. The samples will stored at room temperature until processing for DNA extraction. The saliva samples will be shipped to a laboratory at the University of California San Francisco where the telomere length will be measured by using the monoplex quantitative polymerase chain reaction (qPCR) method. This method has been validated against the Southern blot method. Stout et al. (2017) ran the inter-assay variability test and found that the average coefficient of variation was 2.7% for saliva DNA. Both the saliva collection kit and the telomere length measurement are used only for research purposes (i.e., not commercially available). Stout et al. (2017) report that salivary telomere length was correlated with whole blood telomere length (r = 0.56, p = 0.005).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
Nebraska
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Scottsbluff, Nebraska, United States, 69361
- University of Nebraska Medical Center, College of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Obese Food addicted persons between ages 19 and 70
- Obese Non Food addicted persons between ages 19 and 70
Exclusion Criteria:
- persons with active liver disease
- persons with active cancer
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
length of telomere between two groups
|
|
Participants testing negative for Food Addiction (FA)
these participants have tested negative for Addiction (FA) using the YaleFAS-2 Food Addiction Scale.
|
length of telomere between two groups
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
telomere length
Time Frame: at baseline only
|
cross sectional saliva sample from which telomere length is measured
|
at baseline only
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Trina M Aguirre, PhD, University of Nebraska
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0122-21-EP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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