ISRCTN47562685已完成未知
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 个研究点目标入组 73 人开始时间: 2019年10月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 73
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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)
排除标准
- •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
研究者
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