Abstract
IntroductionGlobal population ageing is one of the key factors linked to the projected rise of dementia incidence. Hence, there is a clear need to identify strategies to overcome this expected health burden and have a meaningful impact on populations’ health worldwide. Current evidence supports the role of modifiable dietary and lifestyle risk factors in reducing the risk of dementia. In South-East Asia, changes in eating and lifestyle patterns under the influence of westernised habits have resulted in significant increases in the prevalence of metabolic, cardiovascular and neurodegenerative non-communicable diseases (NCDs). Low vegetable consumption and high sodium intake have been identified as key contributors to the increased prevalence of NCDs in these countries. Therefore, nutritional and lifestyle strategies targeting these dietary risk factors are warranted. The overall objective of this randomised feasibility trial is to demonstrate the acceptability of a dietary intervention to increase the consumption of high-nitrate green leafy vegetables and reduce salt intake over 6 months among Malaysian adults with raised blood pressure.Methods and analysisPrimary outcomes focus on feasibility measures of recruitment, retention, implementation and acceptability of the intervention. Secondary outcomes will include blood pressure, cognitive function, body composition and physical function (including muscle strength and gait speed). Adherence to the dietary intervention will be assessed through collection of biological samples, 24-hour recall and Food Frequency Questionnaire. A subgroup of participants will also complete postintervention focus groups to further explore the feasibility considerations of executing a larger trial, the ability of these individuals to make dietary changes and the barriers and facilitators associated with implementing these changes.Ethics and disseminationEthical approval has been obtained from Monash University Human Research Ethics Committee and Medical Research and Ethics Committee of Malaysia. Results of the study will be disseminated via peer-reviewed publications and presentations at national and international conferences.ISRCTN47562685; Pre-results.
Highlights
Global population ageing is one of the key factors linked to the projected rise of dementia incidence
Changes in individual eating and lifestyle patterns and rise in food availability and financial prosperity of the population have resulted in significant increases in the prevalence of chronic metabolic, cardiovascular and neurodegenerative non-communicable diseases (NCDs).[12]
With hypertension highlighted as an important modifiable risk factor for dementia,[3 18] more studies that test the implementation of dietary interventions that aim to improve blood pressure are warranted
Summary
►► Feasibility of the first 2×2 trial testing single and combined effects of dietary nitrate and salt reduction for the prevention of cognitive decline in developing countries. ►► Use of objective biomarkers for the assessment of adherence to the dietary intervention and internal validation of the dietary assessment methods used (urinary sodium—24-hour urine vs spot urine/nitrate levels in blood—dried blood spots vs plasma and ELISA vs gold standard/nitrate in saliva—salivary strip (point of care test) vs ELISA using saliva samples). ►► Owing to the small sample size and the feasibility nature of this study, the planned comparative analysis is only exploratory, and the efficacy of the intervention between groups cannot be determined. The results of this study will be instrumental in the design and calculation of the sample size of a larger, follow-on efficacy trial.
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