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Biomarker Study to Evaluate Correlations Between Epigenetic Aging and NAD+ Levels in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT04220658
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : January 7, 2020
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
Elysium Health

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Epigenetics Other: Biomarker study

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
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Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The NAD+ Baseline Study: a Biomarker-based Study to Evaluate Correlations Between Epigenetic Aging and NAD+ Levels in Healthy Volunteers
Actual Study Start Date : December 19, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 3, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Nadide

Groups and Cohorts
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Intervention Details:
  • Other: Biomarker study
    Biomarkers of aging including NAD+ levels in whole blood, interleukins, inflammatory cytokines, growth factors, omega-3 polyunsaturated fatty acids, and patterns in DNA methylation

Outcome Measures
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Primary Outcome Measures :
  1. Correlation between biological age, calculated using DNA isolated from blood, and circulating NAD+ levels [ Time Frame: At baseline ]

Secondary Outcome Measures :
  1. Correlations between biological age, calculated using DNA isolated from saliva, and circulating NAD+ levels [ Time Frame: At baseline ]
  2. Correlations between biological age, calculated using DNA isolated from blood and saliva, and Omega-3 levels in blood [ Time Frame: At baseline ]

Other Outcome Measures:
  1. Age related markers in blood and urine [ Time Frame: At baseline ]

    Correlations between biological age, calculated from DNA isolated from blood and saliva, and the following age-related markers observed in blood and urine:

    • Cellular senescence, proliferation and inflammation: CD3+ and p16INK4a+ T lymphocytes, TNF-α R1, IL-6, IL-8, IL-10, C-reactive protein, eotaxin, activin A, myostatin.
    • NAD-related biomarkers: CD38
    • Cellular health and bioenergetics: mitochondrial DNA and nuclear DNA


Biospecimen Retention:   Samples With DNA
Samples retained for 3 months, with potential for extraction of DNA from whole blood and/or saliva

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy individuals between 25-80 years of age
Criteria

Inclusion Criteria:

  1. Males or females between 25 - 80 (inclusive) years of age
  2. Able and willing to provide written consent, follow instructions to complete study questionnaire(s) and assessments
  3. Peripheral venous access sufficient for blood draw

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Subjects with or who have recently experienced a traumatic injury, infections or undergone major surgery at the discretion of the Qualified Investigator
  4. Donation or receipt of blood products within 90 days.
  5. Clinically significant vital sign or physical examination abnormality at the discretion of the Qualified Investigator.
  6. Subjects with history of pellagra or niacin deficiency
  7. Alcohol use >2 standard alcoholic drinks per day within the past month
  8. History of alcoholism or drug abuse within 1 year prior to screening
  9. Use of medical marijuana or products containing cannabinoids in the 14 days prior to screening.
  10. Use of lipid lowering agents (including fish oil) unless the dose has been stable for greater than 90 days prior to screening.
  11. 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.
  12. 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.
  13. 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
  14. Clinically significant abnormal laboratory results at screening
  15. 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
  16. Consumption of non-water beverage or food within approximately 8 hours of sample collection
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04220658


Locations
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United States, North Carolina
Duke Early Phase Clinical Research Recruiting
Durham, North Carolina, United States, 27710
Contact: Byron Hauser    919-668-0288    byron.hauser@duke.edu   
Contact: Victoria Sutton    919-681-9250    victoria.sutton@duke.edu   
Principal Investigator: Shruti Raja, MD, MHS         
Sponsors and Collaborators
Elysium Health
Duke Clinical Research Institute
Investigators
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Principal Investigator: Jeffrey Guptill, MD Duke Early Phase Clinical Research/DCRI
More Information
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Responsible Party: Elysium Health
ClinicalTrials.gov Identifier: NCT04220658    
Other Study ID Numbers: Baseline Study
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No