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Completed

NCT Number: NCT05243108

Targeting Aging and Promoting Longevity with Exogenous Nucleotides (TALENTs)

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.

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Key information

Age range

60 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Talents project team

Chengdu, Sichuan, 610095, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

dietary nucleotides

Dietary Supplement

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

Placebo

Dietary Supplement

placebo

Primary outcomes

  1. DNAmAge

    Time frame: Baseline、At 2 months、At 4 months

    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.

  2. The length of Leukocyte telomere

    Time frame: Baseline、At 2 months、At 4 months

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

Secondary outcomes

  1. glycolipid metabolic profile

    Time frame: Baseline、 At 2 months、 At 4 months

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

  2. Body composition

    Time frame: Baseline、At 2 months、At 4 months

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

  3. Phenotypic Age

    Time frame: Baseline、 At 2 months、 At 4 months

    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

  4. Spontaneous fluorescence of subcutaneous AGEs

    Time frame: Baseline、At 4 months

    AGEs test

  5. Carotid thickness of intima media

    Time frame: Baseline、At 2 months、At 4 months

    ultrasound

  6. The levels of MDA

    Time frame: Baseline、At 2 months、At 4 months

    In serum

  7. The levels of GSH-Px

    Time frame: Baseline、At 2 months、At 4 months

    In serum

  8. The levels of SOD

    Time frame: Baseline、At 2 months、At 4 months

    In serum

  9. Body circumference

    Time frame: Baseline、At 4 months

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

  10. Gait speed

    Time frame: Baseline、At 4 months

    6m walking time/speed test

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

    Time frame: Baseline、At 4 months

    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.

  12. Time costs of TUG

    Time frame: Baseline、At 4 months

    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.

  13. Grip strength

    Time frame: Baseline、At 4 months

    Calibrated handheld dynamometer.

  14. Pittsburgh sleep quality index (PSQI)

    Time frame: Baseline、 At 4 months

    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.

  15. Score of Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline、At 4 months

    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.

  16. The levels of TNF-α in serum

    Time frame: Baseline、 At 2 months、 At 4 months

    Suspension array

  17. The levels of IL-1 in serum

    Time frame: Baseline、 At 2 months、 At 4 months

    Suspension array

  18. The levels of IL-6 in serum

    Time frame: Baseline、 At 2 months、 At 4 months

    Suspension array

  19. The levels of ICAM-1 in serum

    Time frame: Baseline、 At 2 months、 At 4 months

    Suspension array

  20. Methylation damage

    Time frame: Baseline、 At 4 months

    Blood sample

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

    Time frame: Baseline、 At 4 months

    Blood sample

  22. T lymphocyte subsets

    Time frame: Baseline、 At 2 months、 At 4 months

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

  23. γH2AX

    Time frame: Baseline、 At 2 months、 At 4 months

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

Other outcomes

  1. Gut microbiota

    Time frame: Baseline、At 4 months

    Total bacterial DNA was extracted from fecal samples, followed by 16S-targeted amplification, high-throughput sequencing, species annotation and abundance analysis to describe the intestinal microecological structure and diversity of the subjects

  2. Scores of Quality of life

    Time frame: Baseline、At 4 months

    Quality of life was measured 36-Item Short Form Survey (SF-12) questionnaire. The items are grouped into eight domain scores: physical functioning, role limitations due to physical health, pain, general health, energy, social functioning, role limitations due to emotional problems and emotional well-being. Domain scores can be collapsed to a physical component summary Physical health (PCS) and a mental component summary Mental health (MHS). Each score ranges from 0 to 100, with higher values representing the better self-perceived health-related quality of life.

  3. Dietary intake

    Time frame: Baseline、 At 4 months

    Dietary intake was assessed using a combination of the 24-hour dietary record (24HR) method and the Food Frequency Questionnaire (FFQ)

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2022
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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