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

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

Interventions

DIETARY_SUPPLEMENT

Coenzyme Q10

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

DIETARY_SUPPLEMENT

Selenium

100 mcg tablets provided by Pharma Nord

DIETARY_SUPPLEMENT

Resveratrol

350 mg capsules provided by NOW Foods

DIETARY_SUPPLEMENT

TA-65 MD

100 unit capsules provided by TA Sciences

OTHER

Placebo-1

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

OTHER

Placebo-2

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

Sponsors & Collaborators

• University of Bologna

  collaborator OTHER

• Azienda Usl di Bologna

  collaborator OTHER_GOV

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

  lead OTHER

Principal Investigators

• Paola Forti, MD · University of Bologna and IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-22

Primary Completion

2024-11-30

Completion

2024-11-30

Countries

• Italy

Study Locations