EpigeneticsNCT04220658
Biomarker Study to Evaluate Correlations Between Epigenetic Aging and NAD+ Levels in Healthy Volunteers
An observational study of Epigenetics, run by Elysium Health at 1 site in United States.
Trial summary
This is a single center, prospective study to evaluate correlations between epigenetic aging (as measured via DNA methylation) and NAD+ levels in healthy volunteers. Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Epigenetics
- What is being tested?
- Biomarker study
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2019to 3 Dec 2023
- 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 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals between 25-80 years of age
Who may be able to join
- Males or females between 25 - 80 (inclusive) years of age
- Able and willing to provide written consent, follow instructions to complete study questionnaire(s) and assessments
- Peripheral venous access sufficient for blood draw
Who cannot join
- History of any significant chronic disease including renal, liver, endocrine, inflammatory, cardiovascular, gastro-intestinal, neurological, psychiatric, neoplastic, or metabolic disease, unless well controlled (defined as stable medication regimen) for at least 90 days prior to screening. Clinical significance of active disease will be assessed by the Qualified Investigator to determine eligibility.
- Clinically significant, unstable or untreated medical disorders including recent myocardial ischemia or infarction, unstable angina, uncontrolled hypertension, AIDS, malignancy, epilepsy, and recent cerebrovascular disease that required a change in management or hospitalization within the last 90 days.
- Subjects with or who have recently experienced a traumatic injury, infections or undergone major surgery at the discretion of the Qualified Investigator
- Donation or receipt of blood products within 90 days.
- Clinically significant vital sign or physical examination abnormality at the discretion of the Qualified Investigator.
- Subjects with history of pellagra or niacin deficiency
Show all 16Show fewer
- Alcohol use >2 standard alcoholic drinks per day within the past month
- History of alcoholism or drug abuse within 1 year prior to screening
- Use of medical marijuana or products containing cannabinoids in the 14 days prior to screening.
- Use of lipid lowering agents (including fish oil) unless the dose has been stable for greater than 90 days prior to screening.
- Use of natural health products containing nicotinamide riboside or niacin exceeding the RDA (16mg/day for males and 14mg/day for females) within 14 days prior to Screening. Potential participants will be asked to bring all supplements for evaluation at time of screening.
- History of or current diagnosis of any cancer (except for successfully treated basal or squamous cell carcinoma of the skin) diagnosed less than 5 years prior to screening. Volunteers with cancer in full remission and more than 5 years after diagnosis are acceptable.
- Has participated in any clinical trial with an investigational medicinal product within the past two months prior to the first dose in the current study
- Clinically significant abnormal laboratory results at screening
- Any other condition which in the Investigator's opinion may adversely affect the participant's ability to complete the study or its measures or which may pose significant risk to the participant
- Consumption of non-water beverage or food within approximately 8 hours of sample collection
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Early Phase Clinical Research
Durham, North Carolina, 27710
About this study
Official title: The NAD+ Baseline Study: a Biomarker-based Study to Evaluate Correlations Between Epigenetic Aging and NAD+ Levels in Healthy Volunteers
This is a single center, prospective study to evaluate correlations between epigenetic aging (as measured via DNA methylation) and NAD+ levels in healthy volunteers.
Read the detailed description
This biomarker study consists of a single outpatient visit to the research unit. At this visit, eligibility will be assessed and biomarker samples (blood, saliva and urine) will be collected from subjects meeting eligibility criteria. Consenting subjects with clinically significant screening lab values may be excluded from the study after biomarker sample collection (i.e., clinical lab test results will become available after the biomarker sample collection). The prescribing of drugs to humans will not be part of this protocol.
- Conditions
- Epigenetics
- Being tested
- Biomarker study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker studyOther
Biomarkers of aging including NAD+ levels in whole blood, interleukins, inflammatory cytokines, growth factors, omega-3 polyunsaturated fatty acids, and patterns in DNA methylation
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between biological age, calculated using DNA isolated from blood, and circulating NAD+ levels
Measured: At baseline
Secondary outcomes (2)
Correlations between biological age, calculated using DNA isolated from saliva, and circulating NAD+ levels
Measured: At baseline
Correlations between biological age, calculated using DNA isolated from blood and saliva, and Omega-3 levels in blood
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start19 Dec 2019
- Primary completion1 Dec 2023 (estimated)
- Study completion3 Dec 2023 (estimated)
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpigeneticsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elysium Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Jeffrey Guptill, MD, Principal investigator, Duke Early Phase Clinical Research/DCRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220658
- Sponsor's protocol ID
- Baseline Study
- Status last verified
- Feb 2023
- First submitted
- 3 Jan 2020
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NAD+ Baseline Study: a Biomarker-based Study to Evaluate Correlations Between Epigenetic Aging and NAD+ Levels in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04220658
- Acronym / sponsor ID
- Baseline Study
- Conditions
- Epigenetics
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: COVID-19
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Elysium HealthIndustry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 3 Dec 2023 (estimated)
- First posted
- 7 Jan 2020 (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.
This is a single center, prospective study to evaluate correlations between epigenetic aging (as measured via DNA methylation) and NAD+ levels in healthy volunteers.
Detailed description
This biomarker study consists of a single outpatient visit to the research unit. At this visit, eligibility will be assessed and biomarker samples (blood, saliva and urine) will be collected from subjects meeting eligibility criteria. Consenting subjects with clinically significant screening lab values may be excluded from the study after biomarker sample collection (i.e., clinical lab test results will become available after the biomarker sample collection). The prescribing of drugs to humans will not be part of this protocol.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals between 25-80 years of age
Key inclusion criteria (3 listed)
- Males or females between 25 - 80 (inclusive) years of age
- Able and willing to provide written consent, follow instructions to complete study questionnaire(s) and assessments
- Peripheral venous access sufficient for blood draw
Key exclusion criteria (16 listed)
- History of any significant chronic disease including renal, liver, endocrine, inflammatory, cardiovascular, gastro-intestinal, neurological, psychiatric, neoplastic, or metabolic disease, unless well controlled (defined as stable medication regimen) for at least 90 days prior to screening. Clinical significance of active disease will be assessed by the Qualified Investigator to determine eligibility.
- Clinically significant, unstable or untreated medical disorders including recent myocardial ischemia or infarction, unstable angina, uncontrolled hypertension, AIDS, malignancy, epilepsy, and recent cerebrovascular disease that required a change in management or hospitalization within the last 90 days.
- Subjects with or who have recently experienced a traumatic injury, infections or undergone major surgery at the discretion of the Qualified Investigator
- Donation or receipt of blood products within 90 days.
- Clinically significant vital sign or physical examination abnormality at the discretion of the Qualified Investigator.
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 |
|---|---|---|
| Biomarker studyBiomarkers of aging including NAD+ levels in whole blood, interleukins, inflammatory cytokines, growth factors, omega-3 polyunsaturated fatty acids, and patterns in DNA methylation | Other | – |
Primary outcome
Correlation between biological age, calculated using DNA isolated from blood, and circulating NAD+ levels
Time frame: At baseline
2 secondary outcomes
Correlations between biological age, calculated using DNA isolated from saliva, and circulating NAD+ levels
Time frame: At baseline
Correlations between biological age, calculated using DNA isolated from blood and saliva, and Omega-3 levels in blood
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Jeffrey Guptill, MD principal investigator
Duke Early Phase Clinical Research/DCRI
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 Epigenetics, run by Elysium Health 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 3 inclusion and 16 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: paused, as of the sponsor's last update on 15 Feb 2023. 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?
Results are not available in the source record.
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?
Correlation between biological age, calculated using DNA isolated from blood, and circulating NAD+ levels (time frame: At baseline). 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 15 Feb 2023.