ISRCTN47562685
Completed
未知
A study to investigate the feasibility of a mixed-method intervention to reduce salt intake and increase high-nitrate vegetable consumption in middle-aged and older Malaysian adults with elevated blood pressure
Monash University, Malaysia0 sites73 target enrollmentOctober 11, 2019
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Pre-hypertensive, stage 1 hypertensive or diagnosed hypertensive
- Sponsor
- Monash University, Malaysia
- Enrollment
- 73
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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)
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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