Clinical trial NCT05243108: Targeting Aging and Promoting Longevity with Exogenous Nucleotides (TALENTs)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: anti-aging
DNA methylation age
Insulin Sensitivity/Resistance
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 122
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: completely randomized design
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Male/females of 60 to 70 years of age
2. No serious physical or mental illness
3. Able to provide written Informed Consent
4. Able to follow verbal and written study directions
5. 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.
6. Able to maintain consistent diet and lifestyle habits throughout the study
7. Willing to consume assigned supplement (NTs or placebo) for 4 months

Exclusion Criteria:

1. Participants on the current use of prescription or over-the-counter nucleotides
2. Having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the investigator
3. Documented presence of atherosclerotic disease and/or cardiopulmonary disease
4. History of drug or alcohol abuse
5. 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
6. 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.
7. Currently, or within the past 30 days, enrolled in a different clinical investigation
8. Inability to provide a venous blood sample
9. Unable or unwilling to provide written informed consent for participation in the study

Primary outcomes:
measure: DNAmAge
timeFrame: Baseline、At 2 months、At 4 months
measure: The length of Leukocyte telomere
timeFrame: Baseline、At 2 months、At 4 months
Secondary outcomes:
measure: glycolipid metabolic profile
timeFrame: Baseline、 At 2 months、 At 4 months
measure: Body composition
timeFrame: Baseline、At 2 months、At 4 months
measure: Phenotypic Age
timeFrame: Baseline、 At 2 months、 At 4 months
measure: Spontaneous fluorescence of subcutaneous AGEs
timeFrame: Baseline、At 4 months
measure: Carotid thickness of intima media
timeFrame: Baseline、At 2 months、At 4 months
measure: The levels of MDA
timeFrame: Baseline、At 2 months、At 4 months
measure: The levels of GSH-Px
timeFrame: Baseline、At 2 months、At 4 months
measure: The levels of SOD
timeFrame: Baseline、At 2 months、At 4 months
measure: Body circumference
timeFrame: Baseline、At 4 months
measure: Gait speed
timeFrame: Baseline、At 4 months
measure: The score of the Short Physical Performance Battery (SPPB)
timeFrame: Baseline、At 4 months
measure: Time costs of TUG
timeFrame: Baseline、At 4 months
measure: Grip strength
timeFrame: Baseline、At 4 months
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: Baseline、 At 4 months
measure: Score of Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline、At 4 months
measure: The levels of TNF-α in serum
timeFrame: Baseline、 At 2 months、 At 4 months
measure: The levels of IL-1 in serum
timeFrame: Baseline、 At 2 months、 At 4 months
measure: The levels of IL-6 in serum
timeFrame: Baseline、 At 2 months、 At 4 months
measure: The levels of ICAM-1 in serum
timeFrame: Baseline、 At 2 months、 At 4 months
measure: Methylation damage
timeFrame: Baseline、 At 4 months
measure: The level of telomere repeat binding factors-1 (TRF-1)
timeFrame: Baseline、 At 4 months
measure: T lymphocyte subsets
timeFrame: Baseline、 At 2 months、 At 4 months
measure: γH2AX
timeFrame: Baseline、 At 2 months、 At 4 months
Other outcomes:
measure: Gut microbiota
timeFrame: Baseline、At 4 months
measure: Scores of Quality of life
timeFrame: Baseline、At 4 months
measure: Dietary intake
timeFrame: Baseline、 At 4 months
Locations:
city: Chengdu
country: China
facility: Talents project team
state: Sichuan
Study officials:
affiliation: Peking University
name: Meihong Xu, Assis prof.
role: PRINCIPAL_INVESTIGATOR
References: