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)
Creators: name: Stough, Con
name: Pase, Matthew
name: Cropley, Vanessa
name: Myers, Stephen
name: Nolidin, Karen
name: King, Rebecca
name: Camfield, David
name: Wesnes, Keith
name: Pipingas, Andrew
name: Croft, Kevin
name: Chang, Dennis
name: Scholey, Andrew
Publisher: name: Swinburne
Year: 2024
Subjects: classificationCode: 520201
subject: Behavioural genetics
classificationCode: 520202
subject: Behavioural neuroscience
classificationCode: 520203
subject: Cognitive neuroscience
classificationCode: 520205
subject: Psychopharmacology
classificationCode: 520206
subject: Psychophysiology
classificationCode: 520207
subject: Social and affective neuroscience
classificationCode: 520301
subject: Clinical neuropsychology
classificationCode: 520401
subject: Cognition
classificationCode: 520403
subject: Learning, motivation and emotion

description: 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.