Targeting Aging and Promoting Longevity with Exogenous Nucleotides (TALENTs)
- Conditions
- Aging
- Interventions
- Dietary Supplement: placeboDietary Supplement: dietary nucleotides
- Registration Number
- NCT05243108
- Lead Sponsor
- Peking University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo control group placebo The ingredients, dosage, and usage are the same as experimental. NTs Intervention group dietary nucleotides The subject of 1200mg has been given orally once a day for 4 months.
- Primary Outcome Measures
Name Time Method DNAmAge 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.
The length of Leukocyte telomere Baseline、At 2 months、At 4 months Telomere length was quantified via quantitative PCR, using telomeric DNA amplification compared to a reference gene.
- Secondary Outcome Measures
Name Time Method γH2AX Baseline、 At 2 months、 At 4 months Phosphorylated histone H2AX (p-H2AX) was measured via ELISA
glycolipid metabolic profile Baseline、 At 2 months、 At 4 months fasting glucose, glycated hemoglobin, fasting insulin, HOMA-IR, triglycerides, total cholesterol, LDL-C, HDL-C
Body composition Baseline、At 2 months、At 4 months BIA method - fat mass (grams), lean mass (grams) and total mass (grams).
Phenotypic Age 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
Spontaneous fluorescence of subcutaneous AGEs Baseline、At 4 months AGEs test
Carotid thickness of intima media Baseline、At 2 months、At 4 months ultrasound
The levels of MDA Baseline、At 2 months、At 4 months In serum
The levels of GSH-Px Baseline、At 2 months、At 4 months In serum
The levels of SOD Baseline、At 2 months、At 4 months In serum
Body circumference Baseline、At 4 months Measured with a soft tape - waist, hip, mid-arm, neck and calf circumference
Gait speed Baseline、At 4 months 6m walking time/speed test
The score of the Short Physical Performance Battery (SPPB) 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.
Time costs of TUG 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.
Grip strength Baseline、At 4 months Calibrated handheld dynamometer.
Pittsburgh sleep quality index (PSQI) 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.
Score of Montreal Cognitive Assessment (MoCA) 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.
The levels of TNF-α in serum Baseline、 At 2 months、 At 4 months Suspension array
The levels of IL-1 in serum Baseline、 At 2 months、 At 4 months Suspension array
The levels of IL-6 in serum Baseline、 At 2 months、 At 4 months Suspension array
The levels of ICAM-1 in serum Baseline、 At 2 months、 At 4 months Suspension array
T lymphocyte subsets Baseline、 At 2 months、 At 4 months CD3+, CD4+, CD8+ were analyzed using flow cytometry
Methylation damage Baseline、 At 4 months Blood sample
The level of telomere repeat binding factors-1 (TRF-1) Baseline、 At 4 months Blood sample
Trial Locations
- Locations (1)
Talents project team
🇨🇳Chengdu, Sichuan, China