The feasibility of a dietary intervention to reduce salt intake and increase high-nitrate vegetable consumption in middle-aged and older Malaysian adults with elevated blood pressure

Not Applicable

Completed

• Conditions: Pre-hypertensive, stage 1 hypertensive or diagnosed hypertensive; Circulatory System; Essential (primary) hypertension

• Registration Number: ISRCTN47562685
• Lead Sponsor: Monash University, Malaysia

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32859661/ (added 19/07/2021) 2022 Results article in https://doi.org/10.3390/nu14030430 (added 20/01/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-11
• Study Completion: 2021-01-31
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 73

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Feasibility of the intervention evaluated by:<br> 1. Participant recruitment and retention on the trial<br> 2. Appropriateness and validity of data collection processes and secondary outcome measures<br> 3. Acceptability of intervention by different ethnic group and during different cultural and religious observances<br> 4. Adherence to the intervention evaluated with self-reported (dietary questionnaires) and objective biomarkers (urinary nitrate and salt excretion)<br> 5. Resource capacity for the management of the intervention – identify the direction and magnitude of mismatch in resource expectation and resource capacity<br><br> 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.<br>