Food AddictionNCT05649189
Differences in Length of Telomere in Food Addicted vs Non Food Addicted Persons
An observational study of Food Addiction, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Food Addiction
- What is being tested?
- telomere length measure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2021to 15 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Adult, Older adult
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).
Who may be able to join
- Obese Food addicted persons between ages 19 and 70
- Obese Non Food addicted persons between ages 19 and 70
Who cannot join
- persons with active liver disease
- persons with active cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, College of Nursing
Scottsbluff, Nebraska, 69361
About this study
Official title: A Study of the Differences in Telomere Length Between Patients With and Without Food Addiction
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
Read the 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).
- Conditions
- Food Addiction
- Being tested
- telomere length measure
- Medical subject headings
- Food Addiction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telomere length measureDiagnostic test
length of telomere between two groups
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: telomere length measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
telomere length
cross sectional saliva sample from which telomere length is measured
Measured: at baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start17 Oct 2021
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AddictionStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trina M Aguirre, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649189
- Sponsor's protocol ID
- 0122-21-EP
- Status last verified
- Jan 2024
- First submitted
- 3 Dec 2022
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Group data will be shared via publication.Genetic data will not be shared with individuals or other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Differences in Telomere Length Between Patients With and Without Food Addiction
- ClinicalTrials.gov ID
- NCT05649189
- Acronym / sponsor ID
- 0122-21-EP
- Conditions
- Food Addiction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- University of Washington, University of California, San Francisco
- Study start
- 17 Oct 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants testing positive for Food Addiction (FA) | – | Diagnostic Test: telomere length measurethese participants have tested positive for Food Addiction (FA) at a severe level using the YaleFAS-2 Food Addiction Scale. |
| Participants testing negative for Food Addiction (FA) | – | Diagnostic Test: telomere length measurethese participants have tested negative for Addiction (FA) using the YaleFAS-2 Food Addiction Scale. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Obese Food addicted persons between ages 19 and 70
- Obese Non Food addicted persons between ages 19 and 70
Key exclusion criteria (2 listed)
- persons with active liver disease
- persons with active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telomere length measurelength of telomere between two groups | Diagnostic test | Participants testing negative for Food Addiction (FA), Participants testing positive for Food Addiction (FA) |
Primary outcome
telomere length
Time frame: at baseline only
cross sectional saliva sample from which telomere length is measured
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: No. Group data will be shared via publication.Genetic data will not be shared with individuals or other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trina M Aguirre, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Addiction, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
telomere length (time frame: at baseline only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.