Anti-age Dietary Supplements in Healthy Older Adults: the proBNPage Reduction Trial
NCT ID: NCT05500742
Last Updated: 2023-02-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-07-22
Study Completion Date
2024-11-30
Brief Summary
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Background - The research on the possibilities to extend longevity in humans is presently based on large and long randomized longitudinal studies designed to compare all-cause mortality between treated and control groups. The availability of a simple and reliable marker of biological age might allow an acceleration of the research in this field, demonstrating in small samples and after limited periods of time, the ability of a given treatment to slow down, arrest or even revert the progression of biological age. Our previous studies suggest that this marker of biological age might be the N-terminal of B-type natriuretic peptide precursor (NT-proBNP), from which proBNPage, namely a biological age surrogate in years, can easily be calculated.
Objectives of the study - 1) To fine-tune the method of proBNPage assessment, i.e., to establish the minimum time required to detect a significant increase in proBNPage in a small group of subjects. This will be the duration of next studies to test possible "anti-age" treatments. 2) To assess the ability of 4 "anti-age" treatments, which provided promising results in previous experimental and human studies, to modify proBNPage progression.
Study design - Double-blind randomized clinical trial on a sample of healthy older adults stratified for age and sex.
Study description - One hundred and twenty healthy subjects (in particular, without previous or current cardiovascular diseases) aged 65-80 years of both sexes will be randomized into 3 groups: A) Coenzyme Q10 100 mg bid + Selenium 100 mcg; B) Resveratrol 350 mg bid + TA-65 MD 100 U; C) Placebo-1 bid + Placebo-2. All these subjects will be followed for 2 years and checked 8 times, to assess both proBNPage progression and the safety of the treatments. Handgrip strength, aerobic capacity at the step test and quality of life will also be assessed.
Statistical analysis - In the placebo group, the minimum time required to obtain a significant increase in proBNPage will be established by paired t tests. In the treated groups, possible differences in proBNPage progression with the curve obtained in the placebo group will be sought, both according to intention to treat and in the subjects that will complete the study, by repeated measures ANOVA.
Objectives of the study - 1) To fine-tune the method of proBNPage assessment, i.e., to establish the minimum time required to detect a significant increase in proBNPage in a small group of subjects. This will be the duration of next studies to test possible "anti-age" treatments. 2) To assess the ability of 4 "anti-age" treatments, which provided promising results in previous experimental and human studies, to modify proBNPage progression.
Study design - Double-blind randomized clinical trial on a sample of healthy older adults stratified for age and sex.
Study description - One hundred and twenty healthy subjects (in particular, without previous or current cardiovascular diseases) aged 65-80 years of both sexes will be randomized into 3 groups: A) Coenzyme Q10 100 mg bid + Selenium 100 mcg; B) Resveratrol 350 mg bid + TA-65 MD 100 U; C) Placebo-1 bid + Placebo-2. All these subjects will be followed for 2 years and checked 8 times, to assess both proBNPage progression and the safety of the treatments. Handgrip strength, aerobic capacity at the step test and quality of life will also be assessed.
Statistical analysis - In the placebo group, the minimum time required to obtain a significant increase in proBNPage will be established by paired t tests. In the treated groups, possible differences in proBNPage progression with the curve obtained in the placebo group will be sought, both according to intention to treat and in the subjects that will complete the study, by repeated measures ANOVA.
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Detailed Description
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A) Background
Human life is relatively long so that, to assess the effect of any treatment on longevity, similarly long studies are needed. In addition, to demonstrate significant reductions in mortality, large samples are needed too. Thus, even though several promising treatments have been found in animal models, evidence of efficacy in humans has not come yet.
In an attempt to overcome these difficulties, several indicators of biological age have been proposed. Biological age may be defined as a measure, more reliable than chronological age, of how close to death an individual is. If such an indicator were available, assessing the efficacy of possible treatments would be relatively easy: one or two years of follow-up in relatively small groups might be sufficient to ascertain the arrest or even the inversion of the rise of the indicator.
In 2020 the authors proposed a new simple method to estimate a surrogate of biological age, the "proBNPage", starting from a single laboratory variable, NT-proBNP (the N-terminal fragment of type-B natriuretic peptide precursor). NT-proBNP is easily measurable in most laboratories. It is commonly used as a marker of heart failure, as it is released from the ventricular and atrial myocardium undergoing mechanical or ischemic stress. Several studies (both cross-sectional and longitudinal) have shown that this marker progressively increases with age. It is a good indicator of the risk of death even in subjects without cardiovascular diseases and, in particular, the authors have shown that NT-proBNP is associated with cardiovascular and all-cause mortality more strongly than chronological age. In addition, NT-proBNP is correlated with chronological age more strongly than all the main laboratory variables that had previously been proposed as biomarkers of biological age (as shown by the authors and subsequently also by others). Thus, starting from the equations of the regression lines of chronological age with NT-proBNP, the authors obtained two simple formulas, one for each sex, which allow the calculation of "proBNPage", in years, from the blood concentration of NT-proBNP.
Besides total and cardiovascular mortality, the authors have shown that other indicators of aging are independently associated with proBNPage, such as disease count, walking problems, the fitness assessed with a two-step test and the self-assessment of health status, in addition to previous myocardial infarction, previous stroke, peripheral artery disease and previous arterial revascularizations. Furthermore, in a recent study by other investigators, among more than 35000 clinical and laboratory biomarkers obtained from genomic, proteomic and metabolomic data in 4 cohorts of European populations, NT-proBNP was the marker most strongly associated with frailty in subjects without disability. Finally, in an older adult population, a further recent study has shown that NT-proBNP was the only independent risk factor of reduced intrinsic capacity among 20 laboratory variables, being associated with locomotion, hearing and vision disturbances and with some characteristic psychological aspects of aging.
To test, for the first time, the possible practical use of proBNPage, the authors have designed a study aimed at assessing the effects induced on it by a series of anti-age dietary supplements, which in previous studies have provided interesting results. For the choice of the treatments, the authors have sought the best compromise among available scientific evidence, safety and ease of obtaining the substances on the market.
Coenzyme Q10 (CoQ10): it is the only antioxidant that has been demonstrated to reduce cardiovascular mortality, in combination with selenium, in a sample of general population.
Selenium: selenoproteins contribute to the antioxidant systems of our organism. In addition, selenium has anti-inflammatory effects and is involved in the metabolism of thyroid hormones.
Resveratrol: powerful antioxidant, possible telomerase activator and inhibitor of the target of rapamycin (TOR) system.
TA-65: telomerase activator derived from Astragalus Membranaceus with proven capacity to lengthen telomeres in humans.
B) Study description
Design: Double-blind clinical trial with stratified randomization into 3 treatment groups (one placebo group and two food supplement-treated groups)
Primary objective: To describe, in the context of a longitudinal study lasting 2 years, the spontaneous trend of proBNPage in the placebo group, in order to find the parameters (time to reach a significant increase, magnitude of the increase and its variability) useful for planning future studies on anti-aging treatments.
Secondary objective: To describe, with pilot study, the potential of the proposed treatments to limit the progression of proBNPage, over the 2 years of study, compared to what is observed in the placebo group, to explore the feasibility and organizational needs of future multicenter trials on anti-aging treatments.
Study duration: 2 years
Sample size: 3 groups of 40 subjects each = 120 subjects
Non-institutionalized healthy elderly volunteers of both sexes will be included in the study. Their names and addresses will be obtained from lists provided by the public health service, including subjects aged 65-80 years, taking no more than 4 drugs a day and without recent (\< 3 years) hospital admissions. By random choice, 2000 subjects with the above characteristics will receive a letter with the invitation to participate, together with a short questionnaire for preliminary health status assessment. For acceptation, the volunteers will return the compiled questionnaire by mail. Five hundred are expected to respond and, according to the information provided with the questionnaires, 200 of them will be selected (see inclusion and exclusion criteria) and summoned by phone for the first visit.
Screening assessment (Visit 1) After signing the informed consent, the subjects willing to participate will undergo anamnestic investigation (previous diseases, life habits, basal activities of daily living (ADL), instrumental activities of daily living (IADL), risk factors and medications taken, with all available documentation checked), medical examination (with weight, height, blood pressure and oxygen saturation), ECG and fasting venous blood sampling (for complete blood count, total cholesterol, HDL cholesterol, triglycerides, creatinine, Na, K, Ca, glutamic oxaloacetic transaminase, glutamic pyruvic transaminase, gamma glutamyl transpeptidase, creatine phosphokinase, erythrocyte sedimentation rate, C-reactive protein, blood glucose, glycated hemoglobin, international normalized ratio, activated partial thromboplastin time, and (in men) total and free prostate-specific antigen). According to the inclusion and exclusion criteria, 120 subjects will be selected to be randomized.
Randomization
The 120 selected patients will be subdivided into 4 strata with the following characteristics:
Men with age \>= the median age of men
Men with age \< the median age of men
Women with age \>= the median age of women
Women with age \< the median age of women
Using randomization lists, the subjects belonging to each stratum will be equally distributed among the 3 treatment groups, so that relevant casual displacements of age and sex among the groups will be avoided.
Baseline assessment (Visit 2) The selected subjects will undergo venous blood sampling for NT-proBNP measurement. This will be performed by fluorescence immune assay, using commercially available kits (Quidel).
Subsequent assessments: Visit 3: 14 days - Visit 4: 3 months - Visit 5: 6 months - Visit 6: 12 months - Visit 7: 18 months - Visit 8: 24 months.
Scheduled activities
Verification of safety of dietary supplements with: a) questionnaire for possible adverse reactions (all Visits); b) blood tests (like at Visit 1), ECG, body weight, blood pressure and oxygen saturation (Visits 1,3,4,6,8).
Longitudinal changes of proBNPage, with measurement of NT-proBNP (Visits 2,5,6,7,8).
Assessment of possible effects of dietary supplements on functional frailty indicators: a) Step test; b ) Handgrip; c) Euro QoL-5 Dimension questionnaire (Visits 2,5,6,7,8).
Every 6 months, handing of treatment boxes, collection of previous packages and check of treatments really taken (Visits 2,5,6,7,8).
Verification of possible adverse events, intervened diseases or variations of therapy and search for causes of possible deaths (all Visits)
C) Statistical analysis
Sample size was calculated with the goal of having, in repeated measures ANOVA, a probability of first type error \< 0.05 and a probability of second type error \< 0.20 (power 0.80). Using parameters obtained in our previous studies, the minimum size for each group was 9 (for between-within interaction). To account for probable dropouts, and to allow possible subgroup analysis, a fourfold sample will be opportune, that is, with 40 subjects per group.
Statistical procedures The primary objective of the study (establishing the time to reach a significant increase of proBNPage, the magnitude of the increase and its variability) requires the comparison, with Student's t for paired data, of proBNPage values at Visits 5 (6 months), 6 (12 months), 7 (18 months) and 8 (24 months) with the value at Visit 2 (baseline) in the placebo group.
The effects of treatments will be assessed considering both the completed cases and an intention-to-treat model. The variations (delta) of proBNPage within groups will be compared between groups by repeated measures ANOVA, with reference to the "between-within interaction". Two-tailed tests will be performed throughout, and P values \< 0.05 will be considered significant.
Human life is relatively long so that, to assess the effect of any treatment on longevity, similarly long studies are needed. In addition, to demonstrate significant reductions in mortality, large samples are needed too. Thus, even though several promising treatments have been found in animal models, evidence of efficacy in humans has not come yet.
In an attempt to overcome these difficulties, several indicators of biological age have been proposed. Biological age may be defined as a measure, more reliable than chronological age, of how close to death an individual is. If such an indicator were available, assessing the efficacy of possible treatments would be relatively easy: one or two years of follow-up in relatively small groups might be sufficient to ascertain the arrest or even the inversion of the rise of the indicator.
In 2020 the authors proposed a new simple method to estimate a surrogate of biological age, the "proBNPage", starting from a single laboratory variable, NT-proBNP (the N-terminal fragment of type-B natriuretic peptide precursor). NT-proBNP is easily measurable in most laboratories. It is commonly used as a marker of heart failure, as it is released from the ventricular and atrial myocardium undergoing mechanical or ischemic stress. Several studies (both cross-sectional and longitudinal) have shown that this marker progressively increases with age. It is a good indicator of the risk of death even in subjects without cardiovascular diseases and, in particular, the authors have shown that NT-proBNP is associated with cardiovascular and all-cause mortality more strongly than chronological age. In addition, NT-proBNP is correlated with chronological age more strongly than all the main laboratory variables that had previously been proposed as biomarkers of biological age (as shown by the authors and subsequently also by others). Thus, starting from the equations of the regression lines of chronological age with NT-proBNP, the authors obtained two simple formulas, one for each sex, which allow the calculation of "proBNPage", in years, from the blood concentration of NT-proBNP.
Besides total and cardiovascular mortality, the authors have shown that other indicators of aging are independently associated with proBNPage, such as disease count, walking problems, the fitness assessed with a two-step test and the self-assessment of health status, in addition to previous myocardial infarction, previous stroke, peripheral artery disease and previous arterial revascularizations. Furthermore, in a recent study by other investigators, among more than 35000 clinical and laboratory biomarkers obtained from genomic, proteomic and metabolomic data in 4 cohorts of European populations, NT-proBNP was the marker most strongly associated with frailty in subjects without disability. Finally, in an older adult population, a further recent study has shown that NT-proBNP was the only independent risk factor of reduced intrinsic capacity among 20 laboratory variables, being associated with locomotion, hearing and vision disturbances and with some characteristic psychological aspects of aging.
To test, for the first time, the possible practical use of proBNPage, the authors have designed a study aimed at assessing the effects induced on it by a series of anti-age dietary supplements, which in previous studies have provided interesting results. For the choice of the treatments, the authors have sought the best compromise among available scientific evidence, safety and ease of obtaining the substances on the market.
Coenzyme Q10 (CoQ10): it is the only antioxidant that has been demonstrated to reduce cardiovascular mortality, in combination with selenium, in a sample of general population.
Selenium: selenoproteins contribute to the antioxidant systems of our organism. In addition, selenium has anti-inflammatory effects and is involved in the metabolism of thyroid hormones.
Resveratrol: powerful antioxidant, possible telomerase activator and inhibitor of the target of rapamycin (TOR) system.
TA-65: telomerase activator derived from Astragalus Membranaceus with proven capacity to lengthen telomeres in humans.
B) Study description
Design: Double-blind clinical trial with stratified randomization into 3 treatment groups (one placebo group and two food supplement-treated groups)
Primary objective: To describe, in the context of a longitudinal study lasting 2 years, the spontaneous trend of proBNPage in the placebo group, in order to find the parameters (time to reach a significant increase, magnitude of the increase and its variability) useful for planning future studies on anti-aging treatments.
Secondary objective: To describe, with pilot study, the potential of the proposed treatments to limit the progression of proBNPage, over the 2 years of study, compared to what is observed in the placebo group, to explore the feasibility and organizational needs of future multicenter trials on anti-aging treatments.
Study duration: 2 years
Sample size: 3 groups of 40 subjects each = 120 subjects
Non-institutionalized healthy elderly volunteers of both sexes will be included in the study. Their names and addresses will be obtained from lists provided by the public health service, including subjects aged 65-80 years, taking no more than 4 drugs a day and without recent (\< 3 years) hospital admissions. By random choice, 2000 subjects with the above characteristics will receive a letter with the invitation to participate, together with a short questionnaire for preliminary health status assessment. For acceptation, the volunteers will return the compiled questionnaire by mail. Five hundred are expected to respond and, according to the information provided with the questionnaires, 200 of them will be selected (see inclusion and exclusion criteria) and summoned by phone for the first visit.
Screening assessment (Visit 1) After signing the informed consent, the subjects willing to participate will undergo anamnestic investigation (previous diseases, life habits, basal activities of daily living (ADL), instrumental activities of daily living (IADL), risk factors and medications taken, with all available documentation checked), medical examination (with weight, height, blood pressure and oxygen saturation), ECG and fasting venous blood sampling (for complete blood count, total cholesterol, HDL cholesterol, triglycerides, creatinine, Na, K, Ca, glutamic oxaloacetic transaminase, glutamic pyruvic transaminase, gamma glutamyl transpeptidase, creatine phosphokinase, erythrocyte sedimentation rate, C-reactive protein, blood glucose, glycated hemoglobin, international normalized ratio, activated partial thromboplastin time, and (in men) total and free prostate-specific antigen). According to the inclusion and exclusion criteria, 120 subjects will be selected to be randomized.
Randomization
The 120 selected patients will be subdivided into 4 strata with the following characteristics:
Men with age \>= the median age of men
Men with age \< the median age of men
Women with age \>= the median age of women
Women with age \< the median age of women
Using randomization lists, the subjects belonging to each stratum will be equally distributed among the 3 treatment groups, so that relevant casual displacements of age and sex among the groups will be avoided.
Baseline assessment (Visit 2) The selected subjects will undergo venous blood sampling for NT-proBNP measurement. This will be performed by fluorescence immune assay, using commercially available kits (Quidel).
Subsequent assessments: Visit 3: 14 days - Visit 4: 3 months - Visit 5: 6 months - Visit 6: 12 months - Visit 7: 18 months - Visit 8: 24 months.
Scheduled activities
Verification of safety of dietary supplements with: a) questionnaire for possible adverse reactions (all Visits); b) blood tests (like at Visit 1), ECG, body weight, blood pressure and oxygen saturation (Visits 1,3,4,6,8).
Longitudinal changes of proBNPage, with measurement of NT-proBNP (Visits 2,5,6,7,8).
Assessment of possible effects of dietary supplements on functional frailty indicators: a) Step test; b ) Handgrip; c) Euro QoL-5 Dimension questionnaire (Visits 2,5,6,7,8).
Every 6 months, handing of treatment boxes, collection of previous packages and check of treatments really taken (Visits 2,5,6,7,8).
Verification of possible adverse events, intervened diseases or variations of therapy and search for causes of possible deaths (all Visits)
C) Statistical analysis
Sample size was calculated with the goal of having, in repeated measures ANOVA, a probability of first type error \< 0.05 and a probability of second type error \< 0.20 (power 0.80). Using parameters obtained in our previous studies, the minimum size for each group was 9 (for between-within interaction). To account for probable dropouts, and to allow possible subgroup analysis, a fourfold sample will be opportune, that is, with 40 subjects per group.
Statistical procedures The primary objective of the study (establishing the time to reach a significant increase of proBNPage, the magnitude of the increase and its variability) requires the comparison, with Student's t for paired data, of proBNPage values at Visits 5 (6 months), 6 (12 months), 7 (18 months) and 8 (24 months) with the value at Visit 2 (baseline) in the placebo group.
The effects of treatments will be assessed considering both the completed cases and an intention-to-treat model. The variations (delta) of proBNPage within groups will be compared between groups by repeated measures ANOVA, with reference to the "between-within interaction". Two-tailed tests will be performed throughout, and P values \< 0.05 will be considered significant.
Conditions
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Aging
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Coenzyme Q10 + Selenium
Coenzyme Q10 100 mg bid + Selenium 100 mcg with the evening meal
Group Type
ACTIVE_COMPARATOR
Coenzyme Q10
Intervention Type
DIETARY_SUPPLEMENT
Soft 100 mg capsules containing coenzyme Q10 in vegetable oil provided by Pharma Nord
Selenium
Intervention Type
DIETARY_SUPPLEMENT
100 mcg tablets provided by Pharma Nord
Resveratrol + TA-65
Resveratrol 350 mg bid + TA-65 MD 100 U with the evening meal
Group Type
ACTIVE_COMPARATOR
Resveratrol
Intervention Type
DIETARY_SUPPLEMENT
350 mg capsules provided by NOW Foods
TA-65 MD
Intervention Type
DIETARY_SUPPLEMENT
100 unit capsules provided by TA Sciences
Placebo
Placebo-1 bid + Placebo-2 with the evening meal
Group Type
PLACEBO_COMPARATOR
Placebo-1
Intervention Type
OTHER
Soft capsules containing vegetable oil, externally identical to coenzyme Q10 capsules, provided by Pharma Nord
Placebo-2
Intervention Type
OTHER
Tablets containing excipients, externally identical to selenium tablets, provided by Pharma Nord
Interventions
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Coenzyme Q10
Soft 100 mg capsules containing coenzyme Q10 in vegetable oil provided by Pharma Nord
Intervention Type
DIETARY_SUPPLEMENT
Selenium
100 mcg tablets provided by Pharma Nord
Intervention Type
DIETARY_SUPPLEMENT
Resveratrol
350 mg capsules provided by NOW Foods
Intervention Type
DIETARY_SUPPLEMENT
TA-65 MD
100 unit capsules provided by TA Sciences
Intervention Type
DIETARY_SUPPLEMENT
Placebo-1
Soft capsules containing vegetable oil, externally identical to coenzyme Q10 capsules, provided by Pharma Nord
Intervention Type
OTHER
Placebo-2
Tablets containing excipients, externally identical to selenium tablets, provided by Pharma Nord
Intervention Type
OTHER
Other Intervention Names
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Q10 Gold
SelenoPrecise
Extra Strength Resveratrol
Eligibility Criteria
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Inclusion Criteria
1. Age ranging between 65 and 80 years
2. Signed informed consent
2. Signed informed consent
Exclusion Criteria
1. Previous or current atrial fibrillation
2. History of heart failure
3. History of coronary artery disease (myocardial infarction or angina pectoris)
4. Taking any of the dietary supplements of the present study during the 2 previous months
5. Taking a statin
6. Taking an anticoagulant drug
7. Taking more than 4 drugs a day
8. Hospital admission during the last 3 years
9. Known allergy to any drug of the present study
10. Malignant neoplasm in progress
11. Any other severe disease which, in the opinion of the investigator, contraindicates the participation in the study.
12. Alcohol or drug abuse
13. Participation in other trial
14. Uncertainty of the subject about his/her willingness to follow the study for 2 years
15. Deficit of one or more Activities of Daily Living (ADL)
16. Relevant alterations in the ECG or in the laboratory investigations which, in the opinion of the investigator, contraindicate the participation in the study.
2. History of heart failure
3. History of coronary artery disease (myocardial infarction or angina pectoris)
4. Taking any of the dietary supplements of the present study during the 2 previous months
5. Taking a statin
6. Taking an anticoagulant drug
7. Taking more than 4 drugs a day
8. Hospital admission during the last 3 years
9. Known allergy to any drug of the present study
10. Malignant neoplasm in progress
11. Any other severe disease which, in the opinion of the investigator, contraindicates the participation in the study.
12. Alcohol or drug abuse
13. Participation in other trial
14. Uncertainty of the subject about his/her willingness to follow the study for 2 years
15. Deficit of one or more Activities of Daily Living (ADL)
16. Relevant alterations in the ECG or in the laboratory investigations which, in the opinion of the investigator, contraindicate the participation in the study.
Minimum Eligible Age
65 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Bologna
OTHER
Sponsor Role
collaborator
Azienda Usl di Bologna
OTHER_GOV
Sponsor Role
collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Paola Forti, MD
Role: PRINCIPAL_INVESTIGATOR
University of Bologna and IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy
Locations
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S. Orsola Hospital
Bologna, , Italy
Site Status
Countries
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Italy
References
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Muscari A, Bianchi G, Forti P, Magalotti D, Pandolfi P, Zoli M; Pianoro Study Group. N-terminal pro B-type natriuretic peptide (NT-proBNP): a possible surrogate of biological age in the elderly people. Geroscience. 2021 Apr;43(2):845-857. doi: 10.1007/s11357-020-00249-2. Epub 2020 Aug 11.
Reference Type
BACKGROUND
Muscari A, Bianchi G, Forti P, Giansante C, Giovagnoli M, Magalotti D, Pandolfi P, Perlangeli V, Zorzi V, Zoli M; Pianoro Study Group. A comparison of risk factors as predictors of cardiovascular and non-cardiovascular mortality in the elderly people--relevance of N-terminal pro-B-type natriuretic peptide and low systolic blood pressure. Int J Clin Pract. 2013 Nov;67(11):1182-91. doi: 10.1111/ijcp.12195.
Reference Type
BACKGROUND
Crimmins EM, Thyagarajan B, Kim JK, Weir D, Faul J. Quest for a summary measure of biological age: the health and retirement study. Geroscience. 2021 Feb;43(1):395-408. doi: 10.1007/s11357-021-00325-1. Epub 2021 Feb 5.
Reference Type
BACKGROUND
Muscari A, Bianchi G, Forti P, Magalotti D, Pandolfi P, Zoli M; Pianoro Study Group. The association of proBNPage with manifestations of age-related cardiovascular, physical, and psychological impairment in community-dwelling older adults. Geroscience. 2021 Aug;43(4):2087-2100. doi: 10.1007/s11357-021-00381-7. Epub 2021 May 13.
Reference Type
BACKGROUND
Gomez-Cabrero D, Walter S, Abugessaisa I, Minambres-Herraiz R, Palomares LB, Butcher L, Erusalimsky JD, Garcia-Garcia FJ, Carnicero J, Hardman TC, Mischak H, Zurbig P, Hackl M, Grillari J, Fiorillo E, Cucca F, Cesari M, Carrie I, Colpo M, Bandinelli S, Feart C, Peres K, Dartigues JF, Helmer C, Vina J, Olaso G, Garcia-Palmero I, Martinez JG, Jansen-Durr P, Grune T, Weber D, Lippi G, Bonaguri C, Sinclair AJ, Tegner J, Rodriguez-Manas L; FRAILOMIC initiative. A robust machine learning framework to identify signatures for frailty: a nested case-control study in four aging European cohorts. Geroscience. 2021 Jun;43(3):1317-1329. doi: 10.1007/s11357-021-00334-0. Epub 2021 Feb 18.
Reference Type
BACKGROUND
Ma L, Zhang Y, Liu P, Li S, Li Y, Ji T, Zhang L, Chhetri JK, Li Y. Plasma N-Terminal Pro-B-Type Natriuretic Peptide Is Associated with Intrinsic Capacity Decline in an Older Population. J Nutr Health Aging. 2021;25(2):271-277. doi: 10.1007/s12603-020-1468-3.
Reference Type
BACKGROUND
Alehagen U, Johansson P, Bjornstedt M, Rosen A, Dahlstrom U. Cardiovascular mortality and N-terminal-proBNP reduced after combined selenium and coenzyme Q10 supplementation: a 5-year prospective randomized double-blind placebo-controlled trial among elderly Swedish citizens. Int J Cardiol. 2013 Sep 1;167(5):1860-6. doi: 10.1016/j.ijcard.2012.04.156. Epub 2012 May 23.
Reference Type
BACKGROUND
Salvador L, Singaravelu G, Harley CB, Flom P, Suram A, Raffaele JM. A Natural Product Telomerase Activator Lengthens Telomeres in Humans: A Randomized, Double Blind, and Placebo Controlled Study. Rejuvenation Res. 2016 Dec;19(6):478-484. doi: 10.1089/rej.2015.1793. Epub 2016 Mar 30.
Reference Type
BACKGROUND
Muscari A, Forti P, Brizi M, Magalotti D, Capelli E, Poti S, Piro F, Pandolfi P, Perlangeli V, Ramazzotti E, Barbara G; PBAR Study Group. Can We Slow Down Biological Age Progression? Study Protocol for the proBNPage Reduction (PBAR) Randomized, Double-Blind, Placebo-Controlled Trial (Effects of 4 "Anti-Aging" Food Supplements in Healthy Older Adults). Clin Interv Aging. 2023 Oct 27;18:1813-1825. doi: 10.2147/CIA.S422371. eCollection 2023.
Reference Type
DERIVED
Other Identifiers
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PBAR-2022
Identifier Type: -
Identifier Source: org_study_id
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PHASE2
Study of a Nutritional Supplement for Healthy Aging
NCT06743841
COMPLETED
NA
A Dietary Supplement Examined for Anti-ageing Effects
NCT06714162
NOT_YET_RECRUITING
NA
Effects Of Daily Taurine Intake For 6 Months On Biological Age and Body Metabolism Indicators As Well As Physical Fitness In 55-75-year-old Women And Men
NCT06613542
COMPLETED
NA
Nicotinamide Riboside Supplementation and Exercise Training to Promote Healthy Longevity
NCT06425042
RECRUITING
NA
The Impact of a Polyphenol-Rich Supplement on Epigenetic and Cellular Markers of Immune Age
NCT05234203
COMPLETED
NA
The Impact of Nicotinamide Mononucleotide Sustained-release Tablets on Immunosenescence and Metablism in Middle-aged and Elderly Individuals With Metabolic Disorders.
NCT06907329
RECRUITING
NA
Taurine as a Possible Anti-aging Therapy?
NCT05149716
COMPLETED
NA
Phytochemicals on "Metabolic Aging" in Older Overweight Adults
NCT04919876
UNKNOWN
NA
TA-65 Pharmacokinetic Study
NCT02731807
COMPLETED
PHASE1
Practicality of Intermittent Fasting and Its Effect on Markers of Aging and Oxidative Stress
NCT02132091
COMPLETED
NA
Bioavailability Study of CoQ10 Formulations in Healthy Elderly Adults
NCT03284814
COMPLETED
NA
The PROtein Enriched MEDiterranean Diet and EXercise Trial for Older Adults At Risk of Undernutrition
NCT05166564
COMPLETED
NA
To Evaluate the Efficacy and Safety of NMN as an Anti-ageing Supplement in Middle Aged and Older (40-65 Years) Adults
NCT04823260
COMPLETED
NA
Effects of NAD3 Supplementation on Biomarkers of Aging
NCT04276948
COMPLETED
NA
Mitochondrial-targeted Antioxidant Supplementation for Improving Age-related Vascular Dysfunction in Humans
NCT04851288
ACTIVE_NOT_RECRUITING
PHASE2
The Effects of the Telomerase Activator TA-65 on Insulin Resistance, Inflammation, and Metabolic Syndrome
NCT01753674
TERMINATED
PHASE1
Effects of a Proprietary Blend of Herbal Extract Supplement on Cellular Detoxification, Inflammation, and Cumulative Cognitive Index as Well as Gene Expression in Middle-Aged Adult Women
NCT01598272
COMPLETED
PHASE4
Bioavailability of Ubiquinone and Ubiquinol in Older Adults
NCT03020680
COMPLETED
PHASE1
Multi-Modal Longevity Protocol Including Autologous Cell-Free Conditioned Media
NCT07322224
COMPLETED
NA
TA-65 and Aging Associated Microvascular Dysfunction
NCT05598359
NOT_YET_RECRUITING
NA
Effectiveness of Qualia NAD+ Supplementation on NAD Levels
NCT06812416
COMPLETED
NA
Nicotinamide Adenine Dinucleotide (NAD+) Metabolism in Human Brown Adipose Tissue
NCT06627868
NOT_YET_RECRUITING
NA
Racial and Aging Effects of Acute Antioxidant Supplementation
NCT02157207
COMPLETED
NA