HealthyNCT03734419
The Use of Aging Biomarkers in Saliva, Based on DNA Methylation Status in Elovl2 to Predict Biological Age
An observational study of Healthy, run by HKGepitherapeutics.
Trial summary
There is a big change in our understanding of aging in recent years. Recent researches has revealed clock-like patterns of epigenetic change across in humans. The aging involves a timed epigenetic reprogramming. However, this biological clock which ticks in our DNA is affected by our experience, diet, stress, etc. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Dec 2021
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of men and women aged from 18 to 100 years old of different ethnicities living in Kazakhstan.
Who may be able to join
- Healthy population
Who cannot join
- Chronic diseases
About this study
Official title: Clinical Trials on Prediction of Biological Age Using Saliva Samples of Healthy Population, Based on DNA Methylation Status in ELOVL2 Gene
There is a big change in our understanding of aging in recent years. Recent researches has revealed clock-like patterns of epigenetic change across in humans. The aging involves a timed epigenetic reprogramming. However, this biological clock which ticks in our DNA is affected by our experience, diet, stress, etc. and it could be changed by experience and life style potentially.
The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in ELOVL2-AS1 gene in saliva samples using a next generation sequencing.
- Conditions
- Healthy
- Keywords
- epiaging, biological age, chronological age, DNA methylation, ELOVL2-AS1, ELOVL2
What is being measured
The primary outcome is the main question the study is designed to answer.
The Use of Aging Biomarkers in Saliva, Based on DNA Methylation Status in Elovl2 to Predict Biological Age.
We will develop the linear model and a threshold value correlated with chronological age of the individuals participated in the current study. The model will be provided to the researchers:
Methylation score=(CG1*b1+CG2*b2+ CG3*b3+CGn*n) + e
CG1 is the methylation value of the first CG b1 is the regression coefficient for the first CG and e equals the intercept. n-is a number of CGs in the model
We will develop the regression coefficient and intercept as well as the DNA methylation values for each individual for each CG.
Measured: 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Dec 2019 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Dec 2021 (estimated)
Why it stopped: IRB approval was not obtained for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HKGepitherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734419
- Sponsor's protocol ID
- HKG-Epiaging-104
- Status last verified
- Dec 2023
- First submitted
- 6 Nov 2018
- Last updated
- 21 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trials on Prediction of Biological Age Using Saliva Samples of Healthy Population, Based on DNA Methylation Status in ELOVL2 Gene
- ClinicalTrials.gov ID
- NCT03734419
- Acronym / sponsor ID
- HKG-Epiaging-104
- Conditions
- Healthy
- Keywords
- epiaging, biological age, chronological age, DNA methylation, ELOVL2-AS1, ELOVL2
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: IRB approval was not obtained for this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HKGepitherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 8 Nov 2018 (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.
There is a big change in our understanding of aging in recent years. Recent researches has revealed clock-like patterns of epigenetic change across in humans. The aging involves a timed epigenetic reprogramming. However, this biological clock which ticks in our DNA is affected by our experience, diet, stress, etc. and it could be changed by experience and life style potentially.
The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in ELOVL2-AS1 gene in saliva samples using a next generation sequencing.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of men and women aged from 18 to 100 years old of different ethnicities living in Kazakhstan.
Key inclusion criteria (1 listed)
- Healthy population
Key exclusion criteria (1 listed)
- Chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Use of Aging Biomarkers in Saliva, Based on DNA Methylation Status in Elovl2 to Predict Biological Age.
Time frame: 6 months to 1 year
We will develop the linear model and a threshold value correlated with chronological age of the individuals participated in the current study. The model will be provided to the researchers: Methylation score=(CG1*b1+CG2*b2+ CG3*b3+CGn*n) + e CG1 is the methylation value of the first CG b1 is the regression coefficient for the first CG and e equals the intercept. n-is a number of CGs in the model We will develop the regression coefficient and intercept as well as the DNA methylation values for each individual for each CG.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by HKGepitherapeutics.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The Use of Aging Biomarkers in Saliva, Based on DNA Methylation Status in Elovl2 to Predict Biological Age. (time frame: 6 months to 1 year). 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 21 Dec 2023.