Open Access Research

A randomized controlled trial investigating the effect of Pycnogenol and Bacopa CDRI08 herbal medicines on cognitive, cardiovascular, and biochemical functioning in cognitively healthy elderly people: the Australian Research Council Longevity Intervention (ARCLI) study protocol (ANZCTR12611000487910)

Con K Stough1*, Matthew P Pase1, Vanessa Cropley2, Stephen Myers3, Karen Nolidin1, Rebecca King1, David Camfield1, Keith Wesnes14, Andrew Pipingas1, Kevin Croft5, Dennis Chang6 and Andrew B Scholey1

Author Affiliations

1 Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, Australia

2 Melbourne Neuropsychiatry Centre, The University of Melbourne, Australia

3 Southern Cross University, Lismore, Australia

4 CDR, Bracket, Goring-On-Thames, England

5 School of Medicine and Pharmacology, University of Western Australia, Australia

6 Complemed, NICM, University of Western Sydney, Australia

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Nutrition Journal 2012, 11:11  doi:10.1186/1475-2891-11-11

Published: 6 March 2012

Abstract

Background

One of the major challenges associated with our ageing population is the increasing incidence of age-associated cognitive decline, which has significant implications for an individual's ability to lead a productive and fulfilling life. In pure economic terms the costs of ageing reflects decreased productivity and engagement with the workforce. The maintenance of brain health underpinning intact cognition is a key factor to maintaining a positive, engaged, and productive lifestyle. In light of this, the role of diet, including supplementation with nutritional and even pharmacological interventions capable of ameliorating the neurocognitive changes that occur with age constitute vital areas of research.

Methods

In order to reduce cognitive ageing, the ARC longevity intervention (ARCLI) was developed to examine the effects of two promising natural pharmacologically active supplements on cognitive performance. ARCLI is a randomized, placebo-controlled, double-blind, 3-arm clinical trial in which 465 participants will be randomized to receive an extract of Bacopa monnieri (CDRI08 300 mg/day), Pycnogenol (150 mg/day), or placebo daily for 12 months. Participants will be tested at baseline and then at 3, 6 and 12 months post-randomization on a wide battery of cognitive, neuropsychological and mood measures, cardiovascular (brachial and aortic systolic and diastolic blood pressures as well as arterial stiffness), biochemical (assays to measure inflammation, oxidative stress and safety) as well as genetic assessments (telomere length and several Single Nucleotide Polymorphisms). The primary aim is to investigate the effects of these supplements on cognitive performance. The secondary aims are to explore the time-course of cognitive enhancement as well as potential cardiovascular and biochemical mechanisms underpinning cognitive enhancement over the 12 months of administration.

ARCLI will represent one of the largest and most comprehensive experimental clinical trials in which supplements are administered to elderly participants. Results from ARCLI may help develop novel preventative health practices and nutritional/pharmacological targets in the elderly for cognitive and brain health.

Trial registration

Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12611000487910

Keywords:
Pycnogenol; Bacopa; CDRI08; Pine bark; Brain; Dementia; Cognitive; Cognition; Ageing; RCT