A Randomized Controlled Trial Study to Evaluated the Effect of Exogenous Nucleotides As an Anti-ageing Supplement in Older Adults (60-70 Years)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aging
- Sponsor
- Peking University
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- DNAmAge
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Meihong Xu
Associate professor
Peking University
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
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
- glycolipid metabolic profile(Baseline、 At 2 months、 At 4 months)
- Body composition(Baseline、At 2 months、At 4 months)
- Phenotypic Age(Baseline、 At 2 months、 At 4 months)
- Spontaneous fluorescence of subcutaneous AGEs(Baseline、At 4 months)
- Carotid thickness of intima media(Baseline、At 2 months、At 4 months)
- The levels of MDA(Baseline、At 2 months、At 4 months)
- The levels of GSH-Px(Baseline、At 2 months、At 4 months)
- The levels of SOD(Baseline、At 2 months、At 4 months)
- Body circumference(Baseline、At 4 months)
- Gait speed(Baseline、At 4 months)
- The score of the Short Physical Performance Battery (SPPB)(Baseline、At 4 months)
- Time costs of TUG(Baseline、At 4 months)
- Grip strength(Baseline、At 4 months)
- Pittsburgh sleep quality index (PSQI)(Baseline、 At 4 months)
- Score of Montreal Cognitive Assessment (MoCA)(Baseline、At 4 months)
- The levels of TNF-α in serum(Baseline、 At 2 months、 At 4 months)
- The levels of IL-1 in serum(Baseline、 At 2 months、 At 4 months)
- The levels of IL-6 in serum(Baseline、 At 2 months、 At 4 months)
- The levels of ICAM-1 in serum(Baseline、 At 2 months、 At 4 months)
- T lymphocyte subsets(Baseline、 At 2 months、 At 4 months)
- γH2AX(Baseline、 At 2 months、 At 4 months)
- Methylation damage(Baseline、 At 4 months)
- The level of telomere repeat binding factors-1 (TRF-1)(Baseline、 At 4 months)