High Potassium Diet with Spices and Herbs As Salt Substitute for Lowering Blood Pressure in Older Adults: Study Protocol

Universitas Airlangga

Status: Completed

Conditions: Hypertension; Older Adults Institutionalized in Residential Homes

Treatments: Dietary Supplement: High Potassium, Low Sodium Diet; Dietary Supplement: Standard Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06683430

35/EC/KEPK/FKUA/2023

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups, including a placebo group

Intervention Group High Potassium, Low Sodium Diet

Active Comparator group

Description:

Participants received a diet enriched with potassium (3500 mg K) and reduced sodium (1500 mg Na) for 14 days.

Treatment:

Dietary Supplement: High Potassium, Low Sodium Diet

Control Group Standard Diet (Low Potassium)

Placebo Comparator group

Description:

Participants received a standard diet with low potassium (1700 mg K) and high sodium (2000 mg Na) daily for 14 days.

Treatment:

Dietary Supplement: Standard Diet