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

NCT04220658 | Suspended

• 1 other identifier: Baseline Study
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Epigenetics

Outcome Measures

Primary Outcomes (1)

• Correlation between biological age, calculated using DNA isolated from blood, and circulating NAD+ levels

  At baseline

Secondary Outcomes (2)

• Correlations between biological age, calculated using DNA isolated from saliva, and circulating NAD+ levels

  At baseline

• Correlations between biological age, calculated using DNA isolated from blood and saliva, and Omega-3 levels in blood

  At baseline

Other Outcomes (1)

• Age related markers in blood and urine

  At baseline

Interventions

Biomarker study OTHER

Biomarkers of aging including NAD+ levels in whole blood, interleukins, inflammatory cytokines, growth factors, omega-3 polyunsaturated fatty acids, and patterns in DNA methylation

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy individuals between 25-80 years of age

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Elysium Health: lead
• Duke Clinical Research Institute: collaborator

Study Sites (1)

Duke Early Phase Clinical Research

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

Study Officials

• Jeffrey Guptill, MD

  Duke Early Phase Clinical Research/DCRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 7, 2020
• Study Start: December 19, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 3, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)