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

NCT ID: NCT06683430

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2024-02-09

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Older Adults Institutionalized in Residential Homes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

High Potassium, Low Sodium Diet

Intervention Type DIETARY_SUPPLEMENT

Daily intake of 3500 mg K and 1500 mg Na for 14 days.

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.

Group Type PLACEBO_COMPARATOR

Standard Diet

Intervention Type DIETARY_SUPPLEMENT

Daily intake of 1700 mg K and 2000 mg Na for 14 days.

Interventions

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High Potassium, Low Sodium Diet

Daily intake of 3500 mg K and 1500 mg Na for 14 days.

Intervention Type DIETARY_SUPPLEMENT

Standard Diet

Daily intake of 1700 mg K and 2000 mg Na for 14 days.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitas Airlangga

OTHER

Sponsor Role lead

Responsible Party

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Farapti Farapti

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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government institutional setting in Surabaya, Indonesia, namely Griya Wreda Surabaya nursing home.

Surabaya, Jawa Timur, Angola

Site Status

Countries

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Angola

Other Identifiers

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35/EC/KEPK/FKUA/2023

Identifier Type: -

Identifier Source: org_study_id

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