Clinical trial NCT06683430: High Potassium Diet with Spices and Herbs As Salt Substitute for Lowering Blood Pressure in Older Adults: Study Protocol
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Older Adults Institutionalized in Residential Homes
Keywords: sodium
potassium
spices and herbs
blood pressure
hypertension
elderly
protocol study
gerontology
dietary
anti-hypertensive
oxidative stress
Lead sponsor: Universitas Airlangga
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 62
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Blood Pressure (mmHg)
timeFrame: Baseline, Day 8, and Day 15
Secondary outcomes:
measure: Change in Urinary Potassium Levels (mmol)
timeFrame: Baseline, Day 15
measure: Change in Urinary Sodium Levels (mmol)
timeFrame: Baseline, Day 15
measure: Change in Serum Potassium Levels (mmol/L)
timeFrame: Baseline, Day 15
measure: Change in Plasma Nitric Oxide Levels (µmol/L)
timeFrame: Baseline, Day 15
measure: Change in Plasma F2-Isoprostane Levels (pmol/L)
timeFrame: Baseline, Day 15
measure: Change in Plasma Aldosterone Levels (pmol/L)
timeFrame: Baseline, Day 15
measure: Change in Urinary Na/K Levels (mmol/L)
timeFrame: Baseline, Day 15
Other outcomes:
Locations:
city: Surabaya
country: Angola
facility: government institutional setting in Surabaya, Indonesia, namely Griya Wreda Surabaya nursing home.
state: Jawa Timur
Study officials:
References: