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Clinical Trials/ISRCTN47562685
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)

Registry
who.int
Start Date
October 11, 2019
End Date
January 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Monash University, Malaysia

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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