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Targeting Aging and Promoting Longevity With Exogenous Nucleotides (TALENTs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05243108
Recruitment Status : Active, not recruiting
First Posted : February 16, 2022
Last Update Posted : November 17, 2022
Sponsor:
Information provided by (Responsible Party):
Meihong Xu, 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.

Condition or disease Intervention/treatment Phase
Aging Dietary Supplement: dietary nucleotides Dietary Supplement: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: completely randomized design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The experiment designers used seed number 1234 to generate a random sequence of 120 random numbers on SAS software and divided the 120 random numbers into two groups based on the size of the random numbers. The larger number is Group A, and the smaller number is Group B. Both intervention drugs and placebos are produced by pharmaceutical companies without any labels and look exactly the same. Neither the trial designer nor the pharmacist participated in the trial. The researchers were responsible for recruiting subjects and assigning serial numbers according to inclusion criteria. Caregivers are responsible for dispensing, reviewing, and documenting medications. Investigators are responsible for measuring and filling out questionnaire items. Medical examinations and sample collection are carried out by hospital professionals.
Primary Purpose: Prevention
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)
Actual Study Start Date : August 23, 2022
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NTs Intervention group
The subject of 1200mg has been given orally once a day for 4 months.
Dietary Supplement: dietary nucleotides
1.2 g/d NTs (5 '-AMP, 5' -CMP, 5 '-GMPNa2, 5' -UMPNa2) ;

Placebo Comparator: placebo control group
The ingredients, dosage, and usage are the same as experimental.
Dietary Supplement: placebo
placebo




Primary Outcome Measures :
  1. Phenotypic Age [ Time Frame: Baseline ]
    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

  2. Phenotypic Age [ Time Frame: At 2 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

  3. Phenotypic Age [ Time Frame: 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

  4. The levels of SOD [ Time Frame: Baseline ]
    In serum

  5. The levels of SOD [ Time Frame: At 2 months ]
    In serum

  6. The levels of SOD [ Time Frame: At 4 months ]
    In serum

  7. The levels of GSH-Px [ Time Frame: Baseline ]
    In serum

  8. The levels of GSH-Px [ Time Frame: At 2 months ]
    In serum

  9. The levels of GSH-Px [ Time Frame: At 4 months ]
    In serum

  10. The levels of MDA [ Time Frame: Baseline ]
    In serum

  11. The levels of MDA [ Time Frame: At 2 months ]
    In serum

  12. The levels of MDA [ Time Frame: At 4 months ]
    In serum

  13. Carotid thickness of intima media [ Time Frame: Baseline ]
    ultrasound

  14. Carotid thickness of intima media [ Time Frame: At 2 months ]
    ultrasound

  15. Carotid thickness of intima media [ Time Frame: At 4 months ]
    ultrasound

  16. Spontaneous fluorescence of subcutaneous AGEs [ Time Frame: Baseline ]
    AGEs test

  17. Spontaneous fluorescence of subcutaneous AGEs [ Time Frame: At 2 months ]
    AGEs test

  18. Spontaneous fluorescence of subcutaneous AGEs [ Time Frame: At 4 months ]
    AGEs test


Secondary Outcome Measures :
  1. Body composition [ Time Frame: Baseline ]
    BIA method - fat mass (grams), lean mass (grams) and total mass (grams).

  2. Body composition [ Time Frame: At 2 months ]
    BIA method - fat mass (grams), lean mass (grams) and total mass (grams).

  3. Body composition [ Time Frame: At 4 months ]
    BIA method - fat mass (grams), lean mass (grams) and total mass (grams).

  4. Body circumference [ Time Frame: Baseline ]
    Measured with a soft tape - waist, hip, mid-arm, neck and calf circumference

  5. Body circumference [ Time Frame: At 2 months ]
    Measured with a soft tape - waist, hip, mid-arm, neck and calf circumference

  6. Body circumference [ Time Frame: At 4 months ]
    Measured with a soft tape - waist, hip, mid-arm, neck and calf circumference

  7. Gait speed [ Time Frame: Baseline ]
    6m walking time/speed test

  8. Gait speed [ Time Frame: At 2 months ]
    6m walking time/speed test.

  9. Gait speed [ Time Frame: At 4 months ]
    6m walking time/speed test.

  10. The score of the Short Physical Performance Battery (SPPB) [ Time Frame: Baseline ]
    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.

  11. The score of the Short Physical Performance Battery (SPPB) [ Time Frame: At 2 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.

  12. The score of the Short Physical Performance Battery (SPPB) [ Time Frame: 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.

  13. Time costs of TUG [ Time Frame: Baseline ]
    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.

  14. Time costs of TUG [ Time Frame: At 2 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.

  15. Time costs of TUG [ Time Frame: 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.

  16. Grip strength [ Time Frame: Baseline ]
    Calibrated handheld dynamometer.

  17. Grip strength [ Time Frame: At 2 months ]
    Calibrated handheld dynamometer.

  18. Grip strength [ Time Frame: At 4 months ]
    Calibrated handheld dynamometer.

  19. Weekly physical activity Energy expenditure [ Time Frame: Baseline ]
    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)

  20. Weekly physical activity Energy expenditure [ Time Frame: At 4 months ]
    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)

  21. Pittsburgh sleep quality index (PSQI) [ Time Frame: Baseline ]
    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.

  22. Pittsburgh sleep quality index (PSQI) [ Time Frame: 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.

  23. Score of Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline ]
    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.

  24. Score of Montreal Cognitive Assessment (MoCA) [ Time Frame: 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.

  25. The levels of TNF-α in serum [ Time Frame: Baseline ]
    Suspension array

  26. The levels of TNF-α in serum [ Time Frame: At 4 months ]
    Suspension array

  27. The levels of IL-1 in serum [ Time Frame: Baseline ]
    Suspension array

  28. The levels of IL-1 in serum [ Time Frame: At 4 months ]
    Suspension array

  29. The levels of IL-6 in serum [ Time Frame: Baseline ]
    Suspension array

  30. The levels of IL-6 in serum [ Time Frame: At 4 months ]
    Suspension array

  31. The levels of MCP-1 in serum [ Time Frame: Baseline ]
    Suspension array

  32. The levels of MCP-1 in serum [ Time Frame: At 4 months ]
    Suspension array

  33. The levels of ICAM-1 in serum [ Time Frame: Baseline ]
    Suspension array

  34. The levels of ICAM-1 in serum [ Time Frame: At 4 months ]
    Suspension array

  35. Methylation damage [ Time Frame: Baseline ]
    Blood sample

  36. Methylation damage [ Time Frame: At 4 months ]
    Blood sample

  37. The level of telomere repeat binding factors-1 (TRF-1) [ Time Frame: Baseline ]
    Blood sample

  38. The level of telomere repeat binding factors-1 (TRF-1) [ Time Frame: At 4 months ]
    Blood sample

  39. The level of telomere repeat binding factors-2 (TRF-2) [ Time Frame: Baseline ]
    Blood sample

  40. The level of telomere repeat binding factors-2 (TRF-2) [ Time Frame: At 4 months ]
    Blood sample

  41. The length of Leukocyte telomere [ Time Frame: Baseline ]
    Blood sample

  42. The length of Leukocyte telomere [ Time Frame: At 4 months ]
    Blood sample


Other Outcome Measures:
  1. Gut microbiota [ Time Frame: Baseline ]
    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

  2. Gut microbiota [ Time Frame: At 4 months ]
    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

  3. Scores of Quality of life [ Time Frame: Baseline ]
    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.

  4. Scores of Quality of life [ Time Frame: At 4 months ]
    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.

  5. Nutrition condition [ Time Frame: Baseline ]
    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

  6. Nutrition condition [ Time Frame: At 4 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05243108


Locations
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China, Sichuan
Talents project team
Chengdu, Sichuan, China, 610095
Sponsors and Collaborators
Peking University
Investigators
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Principal Investigator: Meihong Xu, Assis prof. Peking University
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Responsible Party: Meihong Xu, Associate professor, Peking University
ClinicalTrials.gov Identifier: NCT05243108    
Other Study ID Numbers: TALENTs
First Posted: February 16, 2022    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meihong Xu, Peking University:
anti-aging
telomerase