Targeting Aging and Promoting Longevity With Exogenous Nucleotides (TALENTs)

Aging Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05243108
• Other study ID #: TALENTs
• Status: Completed
• Phase: N/A
• Start date: August 23, 2022
• Est. completion date: March 29, 2023

Study information

• Verified date: April 2023
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• dietary nucleotides
1.2 g/d NTs (5 '-AMP, 5' -CMP, 5 '-GMPNa2, 5' -UMPNa2) ;
• placebo
placebo

Locations

Country	Name	City	State
China	Talents project team	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Baseline
Other	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	At 4 months
Other	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.	Baseline
Other	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.	At 4 months
Other	Nutrition condition	Nutrition condition was measured by MNA-SF questionaire. 12 to 14 points of normal nutritional status; 8 to 11 are at risk of malnutrition; 0 to 7 points malnutrition	Baseline
Other	Nutrition condition	Nutrition condition was measured by MNA-SF questionaire. 12 to 14 points of normal nutritional status; 8 to 11 are at risk of malnutrition; 0 to 7 points malnutrition	At 4 months
Primary	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	Baseline
Primary	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	At 2 months
Primary	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	At 4 months
Primary	The levels of SOD	In serum	Baseline
Primary	The levels of SOD	In serum	At 2 months
Primary	The levels of SOD	In serum	At 4 months
Primary	The levels of GSH-Px	In serum	Baseline
Primary	The levels of GSH-Px	In serum	At 2 months
Primary	The levels of GSH-Px	In serum	At 4 months
Primary	The levels of MDA	In serum	Baseline
Primary	The levels of MDA	In serum	At 2 months
Primary	The levels of MDA	In serum	At 4 months
Primary	Carotid thickness of intima media	ultrasound	Baseline
Primary	Carotid thickness of intima media	ultrasound	At 2 months
Primary	Carotid thickness of intima media	ultrasound	At 4 months
Primary	Spontaneous fluorescence of subcutaneous AGEs	AGEs test	Baseline
Primary	Spontaneous fluorescence of subcutaneous AGEs	AGEs test	At 2 months
Primary	Spontaneous fluorescence of subcutaneous AGEs	AGEs test	At 4 months
Secondary	Body composition	BIA method - fat mass (grams), lean mass (grams) and total mass (grams).	Baseline
Secondary	Body composition	BIA method - fat mass (grams), lean mass (grams) and total mass (grams).	At 2 months
Secondary	Body composition	BIA method - fat mass (grams), lean mass (grams) and total mass (grams).	At 4 months
Secondary	Body circumference	Measured with a soft tape - waist, hip, mid-arm, neck and calf circumference	Baseline
Secondary	Body circumference	Measured with a soft tape - waist, hip, mid-arm, neck and calf circumference	At 2 months
Secondary	Body circumference	Measured with a soft tape - waist, hip, mid-arm, neck and calf circumference	At 4 months
Secondary	Gait speed	6m walking time/speed test	Baseline
Secondary	Gait speed	6m walking time/speed test.	At 2 months
Secondary	Gait speed	6m walking time/speed test.	At 4 months
Secondary	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.	Baseline
Secondary	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.	At 2 months
Secondary	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.	At 4 months
Secondary	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.	Baseline
Secondary	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.	At 2 months
Secondary	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.	At 4 months
Secondary	Grip strength	Calibrated handheld dynamometer.	Baseline
Secondary	Grip strength	Calibrated handheld dynamometer.	At 2 months
Secondary	Grip strength	Calibrated handheld dynamometer.	At 4 months
Secondary	Weekly physical activity Energy expenditure	Activities of daily living (ADL). Weekly physical activity Energy expenditure = Physical activity intensity (MET) * time spent per day * days spent per week (MET= METn HN/h), According to the International Physical Activity Scale (IPAQ), the elderly were divided into three levels of physical activity: low (less than 600 METs/ week), medium (600~3 000 METs/ week) and high (over 3 000 METs/ week)	Baseline
Secondary	Weekly physical activity Energy expenditure	Activities of daily living (ADL). Weekly physical activity Energy expenditure = Physical activity intensity (MET) * time spent per day * days spent per week (MET= METn HN/h), According to the International Physical Activity Scale (IPAQ), the elderly were divided into three levels of physical activity: low (less than 600 METs/ week), medium (600~3 000 METs/ week) and high (over 3 000 METs/ week)	At 4 months
Secondary	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.	Baseline
Secondary	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.	At 4 months
Secondary	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.	Baseline
Secondary	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.	At 4 months
Secondary	The levels of TNF-a in serum	Suspension array	Baseline
Secondary	The levels of TNF-a in serum	Suspension array	At 4 months
Secondary	The levels of IL-1 in serum	Suspension array	Baseline
Secondary	The levels of IL-1 in serum	Suspension array	At 4 months
Secondary	The levels of IL-6 in serum	Suspension array	Baseline
Secondary	The levels of IL-6 in serum	Suspension array	At 4 months
Secondary	The levels of MCP-1 in serum	Suspension array	Baseline
Secondary	The levels of MCP-1 in serum	Suspension array	At 4 months
Secondary	The levels of ICAM-1 in serum	Suspension array	Baseline
Secondary	The levels of ICAM-1 in serum	Suspension array	At 4 months
Secondary	Methylation damage	Blood sample	Baseline
Secondary	Methylation damage	Blood sample	At 4 months
Secondary	The level of telomere repeat binding factors-1 (TRF-1)	Blood sample	Baseline
Secondary	The level of telomere repeat binding factors-1 (TRF-1)	Blood sample	At 4 months
Secondary	The level of telomere repeat binding factors-2 (TRF-2)	Blood sample	Baseline
Secondary	The level of telomere repeat binding factors-2 (TRF-2)	Blood sample	At 4 months
Secondary	The length of Leukocyte telomere	Blood sample	Baseline
Secondary	The length of Leukocyte telomere	Blood sample	At 4 months