AzTrials
AzTrials

AgingNCT05243108

Targeting Aging and Promoting Longevity with Exogenous Nucleotides (TALENTs)

A study testing dietary nucleotides in people with Aging, run by Peking University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
dietary nucleotides
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
122 participants
Where
1 siteChina
Study dates
23 Aug 2022to 29 Mar 2023
Phase
Interventional
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 60 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Talents project team

    Chengdu, Sichuan, 610095

Other trials in China

About this study

Official title: A Randomized Controlled Trial Study to Evaluated the Effect of Exogenous Nucleotides As an Anti-ageing Supplement in Older Adults (60-70 Years)

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.

Read the detailed description

To explore the anti-aging effects of NTs and the regulation of aging-related diseases, this study plans to recruit 120 people as subjects and conduct randomized controlled trials with NTs as an intervention for 4 months. Based on computer-generated random numbers, participants who meet the inclusion criteria are randomly assigned equally to two groups: placebo control and nucleotide intervention groups. In this study, the specific nucleotide composition is 5'-AMP、5'-CMP、5'-GMPNa2、5'-UMPNa2 prepared according to the ratio of 16:41:19:24, which is consistent with the ratio in breast milk and meets the requirements of national infant formula addition and special medical food formula. The dose of 1.2 g/day used is currently approved as the ingredient dose of nucleotides in conventional commercially available health food products. At the 0、2 and 4 months of the study, comprehensive geriatric health assessment, aging biomarker testing and biological sample collection will be conducted. Among them, the comprehensive evaluation of elderly health status is carried out by physical examination and questionnaire survey, including physical health, physiological function, quality of life, cognitive function, psychosocial health, and other aspects of information. The physical examination involves both physical assessment and functional assessment, including body composition, neck circumference, waist circumference, hip circumference, middle arm circumference, calf circumference, BMR, grip strength, six-minute walk, intima-media thickness, subcutaneous AGEs, and spirometry. The scale includes health status, nutritional status, cognitive status, physical activity, and dietary status. Blood samples were used to detect the safety and senescence-related indicators of the subjects. The index system covers four modules and seventeen dimensions, including blood routine, blood biochemistry, inflammatory factors, immune antibodies, T lymphocyte subtypes, oxidative stress level, cancer markers, leukocyte telomere length, DNA methylation, γ-H2A. Blood samples are sequenced simultaneously for gene and transcriptome sequencing. Fecal samples are collected for metagenomic sequencing of intestinal flora.

Conditions
Aging
Being tested
dietary nucleotides, placebo
Keywords
anti-aging, DNA methylation age, Insulin Sensitivity/Resistance
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dietary nucleotidesDietary supplement

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

  • placeboDietary supplement

    placebo

Study groups in NCT05243108
Study groupRoleWhat they receive
NTs Intervention groupExperimentalThe subject of 1200mg has been given orally once a day for 4 months.
Receives: Dietary Supplement: dietary nucleotides
placebo control groupPlacebo comparatorThe ingredients, dosage, and usage are the same as experimental.
Receives: Dietary Supplement: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline、At 2 months、At 4 months

  2. The length of Leukocyte telomere

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

    Measured: Baseline、At 2 months、At 4 months

Secondary outcomes (23)

  1. glycolipid metabolic profile

    fasting glucose, glycated hemoglobin, fasting insulin, HOMA-IR, triglycerides, total cholesterol, LDL-C, HDL-C

    Measured: Baseline、 At 2 months、 At 4 months

  2. Body composition

    BIA method - fat mass (grams), lean mass (grams) and total mass (grams).

    Measured: Baseline、At 2 months、At 4 months

  3. Phenotypic Age

    Phenotypic Age=141:50+ln(0.00553*ln(1-xb)). xb=-19:907-0.0336*albuminþ+0.095*creatinine+0.0195*glucose+0.0954*lnCRP-0.0120*lymphocyte percent+0.0268 mean cell volume+0.3356 red blood cell distribution width+0.00188 alkaline phosphatase+0.0554*white blood cell count+0.0804*chronological age

    Measured: Baseline、 At 2 months、 At 4 months

  4. Spontaneous fluorescence of subcutaneous AGEs

    AGEs test

    Measured: Baseline、At 4 months

  5. Carotid thickness of intima media

    ultrasound

    Measured: Baseline、At 2 months、At 4 months

  6. The levels of MDA

    In serum

    Measured: Baseline、At 2 months、At 4 months

  7. The levels of GSH-Px

    In serum

    Measured: Baseline、At 2 months、At 4 months

  8. The levels of SOD

    In serum

    Measured: Baseline、At 2 months、At 4 months

  9. Body circumference

    Measured with a soft tape - waist, hip, mid-arm, neck and calf circumference

    Measured: Baseline、At 4 months

  10. Gait speed

    6m walking time/speed test

    Measured: Baseline、At 4 months

  11. The score of the Short Physical Performance Battery (SPPB)

    The SPPB is a composite test that includes assessments of gait speed, a balance test, and a chair stand test. The maximum score is 12 points, and a score of ≤ 8 points indicates poor physical performance.

    Measured: Baseline、At 4 months

  12. Time costs of TUG

    For the Timed-Up and Go test, individuals are asked to rise from a standard chair, walk to a marker 3 m away, turn around, walk back and sit down again.

    Measured: Baseline、At 4 months

  13. Grip strength

    Calibrated handheld dynamometer.

    Measured: Baseline、At 4 months

  14. Pittsburgh sleep quality index (PSQI)

    Items are categorized into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction. The possible score range for each component is 0 (no difficulty) to 3 (severe difficulty). The seven component scores are summed to produce a global score; higher scores represent poorer subjective sleep quality.

    Measured: Baseline、 At 4 months

  15. Score of Montreal Cognitive Assessment (MoCA)

    Scores range from 0-30 (+1 for 12 or fewer years of education); a score of 26 or higher indicates normal cognitive functioning, while a score of 25 or lower indicates impaired functioning.

    Measured: Baseline、At 4 months

  16. The levels of TNF-α in serum

    Suspension array

    Measured: Baseline、 At 2 months、 At 4 months

  17. The levels of IL-1 in serum

    Suspension array

    Measured: Baseline、 At 2 months、 At 4 months

  18. The levels of IL-6 in serum

    Suspension array

    Measured: Baseline、 At 2 months、 At 4 months

  19. The levels of ICAM-1 in serum

    Suspension array

    Measured: Baseline、 At 2 months、 At 4 months

  20. Methylation damage

    Blood sample

    Measured: Baseline、 At 4 months

  21. The level of telomere repeat binding factors-1 (TRF-1)

    Blood sample

    Measured: Baseline、 At 4 months

  22. T lymphocyte subsets

    CD3+, CD4+, CD8+ were analyzed using flow cytometry

    Measured: Baseline、 At 2 months、 At 4 months

  23. γH2AX

    Phosphorylated histone H2AX (p-H2AX) was measured via ELISA

    Measured: Baseline、 At 2 months、 At 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2022
  2. Study start23 Aug 2022
  3. Primary completion29 Mar 2023
  4. Study completion29 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
completely randomized design
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05243108
Sponsor's protocol ID
TALENTs
Status last verified
Jan 2025
First submitted
26 Nov 2021
Last updated
29 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40433895

Questions about this trial

What is this clinical trial studying?

A study testing dietary nucleotides in people with Aging, run by Peking University at 1 site in China.

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 7 inclusion and 9 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: finished, as of the sponsor's last update on 29 Jan 2025. 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 China. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

DNAmAge (time frame: Baseline、At 2 months、At 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05243108, which also lists 1 linked publication.

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 29 Jan 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT05243108 | AzTrials