NCT05243108

Brief Summary

To investigate the effects of dietary nucleotides (NTs) as an anti-aging supplement, a clinical trial is carried as a randomized, double-blind, parallel design, placebo-controlled. A total of 120 subjects will be enrolled in the study, and they shall be randomly distributed between the two arms, NTs-treated, and placebo-control. They would be given several measurements, including physical examination, questionnaire survey, clinical and aging-related biomarkers tests at 0 (baseline), 2, and 4 months during the RCT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

August 23, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2023

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

November 26, 2021

Last Update Submit

January 26, 2025

Conditions

Keywords

anti-agingDNA methylation ageInsulin Sensitivity/Resistance

Outcome Measures

Primary Outcomes (2)

  • DNAmAge

    DNA methylation clocks were assessed through whole-genome bisulfite sequencing (WGBS).The median of four principal component (PC)-corrected clocks (Horvath, Hannum, GrimAge, and PhenoAge) was chosen as the DNA methylation age outcome measure.

    Baseline、At 2 months、At 4 months

  • The length of Leukocyte telomere

    Telomere length was quantified via quantitative PCR, using telomeric DNA amplification compared to a reference gene.

    Baseline、At 2 months、At 4 months

Secondary Outcomes (23)

  • glycolipid metabolic profile

    Baseline、 At 2 months、 At 4 months

  • Body composition

    Baseline、At 2 months、At 4 months

  • Phenotypic Age

    Baseline、 At 2 months、 At 4 months

  • Spontaneous fluorescence of subcutaneous AGEs

    Baseline、At 4 months

  • Carotid thickness of intima media

    Baseline、At 2 months、At 4 months

  • +18 more secondary outcomes

Other Outcomes (3)

  • Gut microbiota

    Baseline、At 4 months

  • Scores of Quality of life

    Baseline、At 4 months

  • Dietary intake

    Baseline、 At 4 months

Study Arms (2)

NTs Intervention group

EXPERIMENTAL

The subject of 1200mg has been given orally once a day for 4 months.

Dietary Supplement: dietary nucleotides

placebo control group

PLACEBO COMPARATOR

The ingredients, dosage, and usage are the same as experimental.

Dietary Supplement: placebo

Interventions

dietary nucleotidesDIETARY_SUPPLEMENT

1.2 g/d NTs (5 '-AMP, 5' -CMP, 5 '-GMPNa2, 5' -UMPNa2) ;

NTs Intervention group
placeboDIETARY_SUPPLEMENT

placebo

placebo control group

Eligibility Criteria

Age60 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male/females of 60 to 70 years of age
  • No serious physical or mental illness
  • Able to provide written Informed Consent
  • Able to follow verbal and written study directions
  • Must not be taking or be willing to take any supplements containing any form of nucleotides for one year prior to baseline and for the duration of the study.
  • Able to maintain consistent diet and lifestyle habits throughout the study
  • Willing to consume assigned supplement (NTs or placebo) for 4 months

You may not qualify if:

  • Participants on the current use of prescription or over-the-counter nucleotides
  • Having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the investigator
  • Documented presence of atherosclerotic disease and/or cardiopulmonary disease
  • History of drug or alcohol abuse
  • History of unstable depression or mental illness within the last 6 months for which the investigator believes could impact the participant's ability to comply with study requirements
  • Other diseases or medications, according to the investigator, that would interfere directly in the results of the study or jeopardize the health of the participant.
  • Currently, or within the past 30 days, enrolled in a different clinical investigation
  • Inability to provide a venous blood sample
  • Unable or unwilling to provide written informed consent for participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Talents project team

Chengdu, Sichuan, 610095, China

Location

Related Publications (1)

  • Wang S, Song L, Fan R, Chen Q, Fu R, You M, Wu Y, Cai M, Li Y, Xu M. Nucleotides as an Anti-Aging Supplementation in Older Adults: A Randomized Controlled Trial (TALENTs study). Adv Sci (Weinh). 2025 Sep;12(33):e2417728. doi: 10.1002/advs.202417728. Epub 2025 May 28.

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Meihong Xu, Assis prof.

    Peking University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The experiment designers used seed number 1234 to generate a random sequence of 120 random numbers on SAS software and divided the 120 random numbers into two groups based on the size of the random numbers. The larger number is Group A, and the smaller number is Group B. Both intervention drugs and placebos are produced by pharmaceutical companies without any labels and look exactly the same. Neither the trial designer nor the pharmacist participated in the trial. The researchers were responsible for recruiting subjects and assigning serial numbers according to inclusion criteria. Caregivers are responsible for dispensing, reviewing, and documenting medications. Investigators are responsible for measuring and filling out questionnaire items. Medical examinations and sample collection are carried out by hospital professionals.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: completely randomized design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 26, 2021

First Posted

February 16, 2022

Study Start

August 23, 2022

Primary Completion

March 29, 2023

Study Completion

March 29, 2023

Last Updated

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations