An interventional study of dietary nucleotides and placebo in Aging, sponsored by Peking University. Completed at 1 site in China. Open to participants aged 60 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Peking University · Not applicable, Interventional, and Prevention
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.
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.
Peking University is the lead sponsor of 411 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The subject of 1200mg has been given orally once a day for 4 months.
Dietary Supplement: dietary nucleotides
The ingredients, dosage, and usage are the same as experimental.
Dietary Supplement: placebo
1.2 g/d NTs (5 '-AMP, 5' -CMP, 5 '-GMPNa2, 5' -UMPNa2) ;
placebo
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.
Time frame: 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.
Time frame: Baseline、At 2 months、At 4 months
glycolipid metabolic profile
fasting glucose, glycated hemoglobin, fasting insulin, HOMA-IR, triglycerides, total cholesterol, LDL-C, HDL-C
Time frame: Baseline、 At 2 months、 At 4 months
Body composition
BIA method - fat mass (grams), lean mass (grams) and total mass (grams).
Time frame: Baseline、At 2 months、At 4 months
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
Time frame: Baseline、 At 2 months、 At 4 months
Spontaneous fluorescence of subcutaneous AGEs
AGEs test
Time frame: Baseline、At 4 months
Carotid thickness of intima media
ultrasound
Time frame: Baseline、At 2 months、At 4 months
The levels of MDA
In serum
Time frame: Baseline、At 2 months、At 4 months
The levels of GSH-Px
In serum
Time frame: Baseline、At 2 months、At 4 months
The levels of SOD
In serum
Time frame: Baseline、At 2 months、At 4 months
Body circumference
Measured with a soft tape - waist, hip, mid-arm, neck and calf circumference
Time frame: Baseline、At 4 months
Gait speed
6m walking time/speed test
Time frame: Baseline、At 4 months
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.
Time frame: Baseline、At 4 months
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.
Time frame: Baseline、At 4 months
Grip strength
Calibrated handheld dynamometer.
Time frame: Baseline、At 4 months
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.
Time frame: Baseline、 At 4 months
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.
Time frame: Baseline、At 4 months
The levels of TNF-α in serum
Suspension array
Time frame: Baseline、 At 2 months、 At 4 months
The levels of IL-1 in serum
Suspension array
Time frame: Baseline、 At 2 months、 At 4 months
The levels of IL-6 in serum
Suspension array
Time frame: Baseline、 At 2 months、 At 4 months
The levels of ICAM-1 in serum
Suspension array
Time frame: Baseline、 At 2 months、 At 4 months
Methylation damage
Blood sample
Time frame: Baseline、 At 4 months
The level of telomere repeat binding factors-1 (TRF-1)
Blood sample
Time frame: Baseline、 At 4 months
T lymphocyte subsets
CD3+, CD4+, CD8+ were analyzed using flow cytometry
Time frame: Baseline、 At 2 months、 At 4 months
γH2AX
Phosphorylated histone H2AX (p-H2AX) was measured via ELISA
Time frame: Baseline、 At 2 months、 At 4 months
Gut microbiota
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
Time frame: Baseline、At 4 months
Scores of Quality of life
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.
Time frame: Baseline、At 4 months
Dietary intake
Dietary intake was assessed using a combination of the 24-hour dietary record (24HR) method and the Food Frequency Questionnaire (FFQ)
Time frame: Baseline、 At 4 months
Plan to share: No
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Peking University