Multifaceted intervention to enhance cognition in older people at risk of cognitive decline: study protocol for the Protein Omega-3 and Vitamin D Exercise Research (PONDER) study

Abstract

IntroductionAn increasing number of people are living with cognitive impairment and dementia. Current pharmacological therapies at best reduce Alzheimer’s disease symptomatology but do not delay dementia onset in those at high risk. Structured exercise interventions can enhance cognition in older people; however, to produce long lasting, clinically relevant cognitive benefits, it is proposed that a multifaceted approach incorporating exercise with dietary supplements will address a wider range of mechanisms involved in cognitive decline. The Protein Omega-3 aNd vitamin D Exercise Research (PONDER) study aims to investigate the cognitive effects of a multimodal exercise programme combined with nutritional supplementation in older adults with subjective memory impairment (SMI).Methods and analysisThe PONDER study is a single-centre, 12-month, community-based, parallel group, randomised, double-blind, placebo controlled trial involving a 6-month multifaceted intervention with a further 6-month follow-up. Participants will be 148 people from Melbourne, Australia, aged 60–85 years with SMI who will be randomised (1:1 ratio) to either a 6-month supervised multimodal exercise programme combined with omega-3 fatty acid, vitamin D and protein supplementation or a stretching/flexibility exercise programme combined with placebo supplements. The primary outcome is the change in cognition after 6 months as assessed by the Trail Making Test and global cognitive function assessed from the Cogstate Computerised battery. Secondary outcomes will include memory, working memory/learning and attention/psychomotor function, the Montreal Cognitive Assessment, mood, quality of life, muscle strength, physical function, body composition, cardiovascular health and sleep quality. Cognition at 12 months will represent a secondary outcome.Ethics and disseminationThis study has been approved by the Deakin University Human Research Ethics Committee (project 2016–260). Informed consent will be obtained from all participants. The authors intend to submit the findings of the study to peer-reviewed journals or academic conferences to be published.Trial registration numberACTRN12616001549415; Pre-results.

Healthy Lifestyle and Cognition: Interaction between Diet and Physical Activity

“…In general, these data provide evidence that a longer-term combined nutrition and exercise intervention elicit stronger positive results than each intervention in isolation. Several trials examining multifaceted approaches of exercise combined with nutrition on cognitive function are currently ongoing, including the Protein Omega-3 aNd vitamin D Exercise Research (PONDER, 6-month multimodal exercise program combined with omega-3 PUFA, vitamin D and protein supplementation compared to a stretching/flexibility exercise control program) [93], SYNchronizing Exercises, Remedies in GaIt and Cognition (SYNERGIC, 6-month combined aerobic and resistance exercise program with and without cognitive training and vitamin D supplementation) [94], and US Study to Protect Brain Health through Lifestyle Intervention to Reduce Risk (US POINTER: 2-year self-guided versus structured multimodal lifestyle intervention) [95] studies. While it is clear that more research is needed into the potential synergistic effect of diet and exercise on mechanisms that effect cognition, such as cerebral blood flow, neurotransmitter release, and brain structure and function changes, results from ongoing studies may provide further evidence of the interaction.…”

Lifestyle interventions.

“…Further, it was demonstrated that improvements in processing speed were greater in individuals with fewer structural brain changes at baseline (Trichopoulou et al, 2003), suggesting that targeted strategies may be more effective if started early. Several trials examining multifaceted approaches of exercise combined with nutrition on neurocognitive function are currently ongoing and include various modes of exercise (e.g., aerobic, resistance, yoga) as well as diet (e.g., omega-3s, protein, vitamin D; Baker et al, 2019;Macpherson et al, 2019;Montero-Odasso et al, 2018).…”

"Cognition and Omega-3 Fatty Acids: A Narrative Review of the Literature"

“…Anyway, a subgroup analysis subsequently found that omega-3 supplementation would be partially beneficial in those subjects who had low baseline omega-3 levels [33]. Another ambitious trial in this population subset is the PONDER study, for which no results have yet been obtained [34].…”