Pre-hypertensive, stage 1 hypertensive or diagnosed hypertensive Circulatory System Essential (primary) hypertension
Conditions
Interventions
This dietary and behavioural intervention will focus on key components of local dietary patterns influenced by nutritional transition trends and aims to target two key components with protective (gree
Sponsors
Monash University, Malaysia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female participants with an age between 50 and 75 years from the participants of SEACO 2. Pre-hypertensive, stage 1 hypertensive or diagnosed hypertensive: Any person who has a self-reported history of hypertension (on or not on medication) or those who had a blood pressure recording of systolic blood pressure 120-159 mmHg or diastolic blood pressure 80-99 mmHg 3. Participants will have a body mass index greater than 18.5 kg/m2 4. Not severely cognitively impaired (defined as a Mini Mental Examination Status [MMSE] score of 19 or over)
Exclusion criteria
Exclusion criteria: 1. Are participating in other research clinical studies 2. Are unable to provide consent 3. Adhere to any therapeutic diet such as weight loss treatments or a gluten-free diet 4. Have systolic blood pressure more than or equal to 160 mmHg and /or diastolic blood pressure more than or equal to 100 mmHg 5. Are strictly vegan (likely to have a high intake of vegetables). Since Chinese and Indian participants are more likely to follow a vegetarian or semi-vegetarian diet, in order to maintain representativeness across ethnic groups included in the study, only participants on strictly vegetarian diet (i.e., vegans) will be excluded from the study 6. Have a history of active cancer and any diagnosis of malignant cancer in the last 5 years 7. Have a history of excessive alcohol intake (>21 units of alcohol per week) 8. Have a history of brain damage, significant head trauma (including loss of consciousness as a result) 9. Have a diagnosis of acute and chronic medical conditions interfering with the study outcomes such as systemic infections (tuberculosis, hepatitis B, HIV/AIDS), severe liver and kidney diseases, inflammatory bowel diseases, coronary heart diseases, cerebrovascular diseases or diabetes on insulin therapy 10. Have had any major surgical operations (in the past six weeks or planned in next one year) that could interfere with the study outcomes 11. Have current diagnosis of moderate or severe depression, or other serious mental or brain disorder and currently treated with psychiatric drugs (antidepressants, sedatives, antipsychotics) 12. Have systemic use of sodium-altering drugs (angiotensin-converting-enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), corticosteroids, diuretics, hormonal therapies (oestrogens, thyroxin, and progesterone), non-steroidal anti-inflammatory drugs (NSAIDs), proton-pump inhibitors), organic nitrates 13. Have a change in anti-hypertensive medication regimen for the previous 3 months (to make sure these disorders are under strict control to avoid interference with the study outcomes) 14. Have limited mobility due to any reason 15. Are planning to move house in next one year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of the intervention evaluated by: 1. Participant recruitment and retention on the trial 2. Appropriateness and validity of data collection processes and secondary outcome measures 3. Acceptability of intervention by different ethnic group and during different cultural and religious observances 4. Adherence to the intervention evaluated with self-reported (dietary questionnaires) and objective biomarkers (urinary nitrate and salt excretion) 5. Resource capacity for the management of the intervention – identify the direction and magnitude of mismatch in resource expectation and resource capacity These feasibility considerations will be assessed by questionnaire and review of field notes at baseline, 2 months, 4 months, 6 months, and by focus group discussion post intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cognitive test performance - A validated version of Montreal Cognitive Assessment test (MoCA), auditory verbal learning test, categorical verbal fluency and trail making test (TMT) part B will be conducted at baseline and end of study visits 2. Resting blood pressure - Three consecutive measurements of resting blood pressure readings will be recorded in sitting position using a calibrated OMRON monitor. The median measure will be used to estimate the blood pressure. Blood pressure will be measured at all outcome assessment visits (baseline, 2 months, 4 months and 6 months) 3. Body composition: height (by stadiometer), weight (by weighing scales), waist circumference (by tape measure), body fat (by Tanita body composition monitor). Body composition will be measured at baseline and end of study visits 4. Physical performance: hand-grip strength (by a hand grip-strength dynamometer), gait speed (4 meter walk test) and mobility (Timed Up and Go (TUG) test). Physical assessments will be conducted at baseline and end of study visits 5. Behaviour change - adherence to nutritional interventions measured by dietary methods (multiple-pass 24-hr recall; FFQ) and urinary biomarkers (24-hr sodium and nitrate excretion). These assessments will be conducted at baseline and 6 months (interim adherence check at 2 and 4 months by spot urine). Saliva samples and salivary strips will be also collected to measure changes in nitrite concentrations during the intervention at baseline and 6 months (interim adherence check at 2 and 4 months by saliva strips) 6. Plasma biochemical outcomes monitored including routine biomarkers of cardio-vascular risk (C-reactive protein, glycated haemoglobin, nitro-tyrosine) and more direct brain measures such as plasma brain-derived neurotrophic factor and plasma amyloid ß42 and amyloid ß40. All blood sampling assessment methods will be conducted at baseline and end of study visits | — |
Countries
Malaysia
Outcome results
None listed