High Potassium Diet Rich in Spices and Herbs-Salt Substitution (HPSH-SS) for Blood Pressure Reduction in Older Adults: Protocol for Diet Concept and Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in Blood Pressure (mmHg)
研究概览
简要总结
This clinical trial aims to evaluate the High Potassium Diet Rich in Spices and Herbs-Salt Substitution (HPSH-SS) for reducing blood pressure in older adults. The study has two phases: the first focuses on developing a high-potassium, low-sodium diet, while the second involves a 14-day randomized controlled trial. Participants are divided into two groups: the intervention group (IG) receives an 1800 kcal daily diet with 3500 mg potassium and 1500 mg sodium, while the control group (CG) receives a diet with 1500 mg potassium and 2000 mg sodium. Key outcomes include changes in blood pressure, serum potassium, aldosterone, nitric oxide, and oxidative stress markers. The results could provide new dietary strategies for managing blood pressure in the elderly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •older adults aged ≥60 years residing in the nursing
- •active and not bedridden
- •without infectious disease, taste disorders, or dementia
- •have blood pressure measurements indicating a systolic blood pressure (SBP) ≥130 mmHg and/or diastolic blood pressure (DBP) ≥85 mmHg
排除标准
- •individuals with impaired kidney function (creatinine serum levels >1.2 mmol/L)
- •uncontrolled diabetes mellitus (fasting blood sugar >126 mg/dL)
- •obesity (BMI ≥30 kg/m2 )
- •active smokers
- •have memory impairment and depressive conditions
- •participants declining continued participation, requiring intensive hospital care, or experiencing persistent vomiting and diarrhea were excluded from the intervention.
研究组 & 干预措施
Intervention Group High Potassium, Low Sodium Diet
Participants received a diet enriched with potassium (3500 mg K) and reduced sodium (1500 mg Na) for 14 days.
干预措施: High Potassium, Low Sodium Diet (Dietary Supplement)
Control Group Standard Diet (Low Potassium)
Participants received a standard diet with low potassium (1700 mg K) and high sodium (2000 mg Na) daily for 14 days.
干预措施: Standard Diet (Dietary Supplement)
结局指标
主要结局
Change in Blood Pressure (mmHg)
时间窗: Baseline, Day 8, and Day 15
Measurement of the change in systolic and diastolic blood pressure from baseline to Day 8 and Day 15 to evaluate the effect of the high-potassium, low-sodium diet intervention.
次要结局
- Change in Urinary Potassium Levels (mmol)(Baseline, Day 15)
- Change in Urinary Sodium Levels (mmol)(Baseline, Day 15)
- Change in Serum Potassium Levels (mmol/L)(Baseline, Day 15)
- Change in Plasma Nitric Oxide Levels (µmol/L)(Baseline, Day 15)
- Change in Plasma F2-Isoprostane Levels (pmol/L)(Baseline, Day 15)
- Change in Plasma Aldosterone Levels (pmol/L)(Baseline, Day 15)
- Change in Urinary Na/K Levels (mmol/L)(Baseline, Day 15)
研究者
Farapti Farapti
Lecturer
Universitas Airlangga