Anti-age Dietary Supplements in Healthy Older Adults: the proBNPage Reduction Trial

NCT05500742 | Unknown

• 1 other identifier: PBAR-2022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging

Keywords

Aging; Anti-age treatments; NT-proBNP; Coenzyme Q10; Selenium; Resveratrol; TA-65

Outcome Measures

Primary Outcomes (4)

• Change from baseline ProBNPage at 6 months

  Change of surrogate, in years, of biological age, derived from mathematical transformation of NT-proBNP blood concentration with separate formulas for the two sexes

  6 months

• Change from baseline ProBNPage at 12 months

  Change of surrogate, in years, of biological age, derived from mathematical transformation of NT-proBNP blood concentration with separate formulas for the two sexes

  12 months

• Change from baseline ProBNPage at 18 months

  Change of surrogate, in years, of biological age, derived from mathematical transformation of NT-proBNP blood concentration with separate formulas for the two sexes

  18 months

• Change from baseline ProBNPage at 24 months

  Change of surrogate, in years, of biological age, derived from mathematical transformation of NT-proBNP blood concentration with separate formulas for the two sexes

  24 months

Secondary Outcomes (4)

• Handgrip strength change

  Baseline, 6 months, 12 months, 18 months, 24 months

• Step test change

  Baseline, 6 months, 12 months, 18 months, 24 months

• Euro QoL 5 dimension questionnaire change

  Baseline, 6 months, 12 months, 18 months, 24 months

• Euro QoL 5 dimension Visual Analog Scale change

  Baseline, 6 months, 12 months, 18 months, 24 months

Study Arms (3)

Coenzyme Q10 + Selenium

ACTIVE COMPARATOR

Coenzyme Q10 100 mg bid + Selenium 100 mcg with the evening meal

Dietary Supplement: Coenzyme Q10; Dietary Supplement: Selenium

Resveratrol + TA-65

ACTIVE COMPARATOR

Resveratrol 350 mg bid + TA-65 MD 100 U with the evening meal

Dietary Supplement: Resveratrol; Dietary Supplement: TA-65 MD

Placebo

PLACEBO COMPARATOR

Placebo-1 bid + Placebo-2 with the evening meal

Other: Placebo-1; Other: Placebo-2

Interventions

Coenzyme Q10 DIETARY_SUPPLEMENT

Soft 100 mg capsules containing coenzyme Q10 in vegetable oil provided by Pharma Nord

Also known as: Q10 Gold

Coenzyme Q10 + Selenium

Selenium DIETARY_SUPPLEMENT

100 mcg tablets provided by Pharma Nord

Also known as: SelenoPrecise

Coenzyme Q10 + Selenium

Resveratrol DIETARY_SUPPLEMENT

350 mg capsules provided by NOW Foods

Also known as: Extra Strength Resveratrol

Resveratrol + TA-65

TA-65 MD DIETARY_SUPPLEMENT

100 unit capsules provided by TA Sciences

Resveratrol + TA-65

Placebo-1 OTHER

Soft capsules containing vegetable oil, externally identical to coenzyme Q10 capsules, provided by Pharma Nord

Placebo

Placebo-2 OTHER

Tablets containing excipients, externally identical to selenium tablets, provided by Pharma Nord

Placebo

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ranging between 65 and 80 years
• Signed informed consent

You may not qualify if:

• Previous or current atrial fibrillation
• History of heart failure
• History of coronary artery disease (myocardial infarction or angina pectoris)
• Taking any of the dietary supplements of the present study during the 2 previous months
• Taking a statin
• Taking an anticoagulant drug
• Taking more than 4 drugs a day
• Hospital admission during the last 3 years
• Known allergy to any drug of the present study
• Malignant neoplasm in progress
• Any other severe disease which, in the opinion of the investigator, contraindicates the participation in the study.
• Alcohol or drug abuse
• Participation in other trial
• Uncertainty of the subject about his/her willingness to follow the study for 2 years
• Deficit of one or more Activities of Daily Living (ADL)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• University of Bologna: collaborator
• Azienda Usl di Bologna: collaborator

Study Sites (1)

S. Orsola Hospital

Bologna, 40138, Italy

Location

Related Publications (9)

• 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.

  PMID: 32780292 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.

  PMID: 24165431 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.

  PMID: 33544281 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.

  PMID: 33987773 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.

  PMID: 33599920 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.

  PMID: 33491044 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.

  PMID: 22626835 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.

  PMID: 26950204 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.

  PMID: 37915546 DERIVED

MeSH Terms

Interventions

coenzyme Q10; Selenium; Resveratrol

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals; Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Paola Forti, MD

  University of Bologna and IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 15, 2022
• Study Start: July 22, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 2, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for 10 years after publication of study results
• Access Criteria: Email request to principal investigator

Locations

IT (1)