Clinical trial NCT05649189: Differences in Length of Telomere in Food Addicted vs Non Food Addicted Persons
Official title: A Study of the Differences in Telomere Length Between Patients With and Without Food Addiction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Addiction
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: University of Washington
name: University of California, San Francisco
First posted: 2022-12-13
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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).

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: telomere length
timeFrame: at baseline only
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsbluff
country: United States
facility: University of Nebraska Medical Center, College of Nursing
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Trina M Aguirre, PhD
role: PRINCIPAL_INVESTIGATOR
References: