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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universitas Airlangga
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Change in Blood Pressure (mmHg)
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change in Blood Pressure (mmHg)
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Farapti Farapti
Lecturer
Universitas Airlangga