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Completed

NCT Number: NCT06683430

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Surabaya, Jawa Timur, 60232, Angola

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Potassium, Low Sodium Diet

Dietary Supplement

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

Standard diet

Dietary Supplement

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

Primary outcomes

  1. 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

  1. Change in Urinary Potassium Levels (mmol)

    Time frame: Baseline, Day 15

    All participants were provided with written and verbal instructions on the correct procedure for 24-hour urine collection to measure Na and K levels. Nurses were also instructed to assist participants with this process. Participants were asked to ensure accurate 24-hour urine collection and report any missing or uncollected urine. The urine samples were then transported by researchers to an internationally certified ISO 9001 labor laboratory for analysis of Na and K levels using the ion-selective electrode (ISE) method, which specifically responds to anions and cations. Urinary K levels were categorized as low (< 25 mmol), normal (25-125 mmol), and high (> 125 mmol).

  2. Change in Urinary Sodium Levels (mmol)

    Time frame: Baseline, Day 15

    All participants were provided with written and verbal instructions on the correct procedure for 24-hour urine collection to measure Na and K levels. Nurses were also instructed to assist participants with this process. Participants were asked to ensure accurate 24-hour urine collection and report any missing or uncollected urine. The urine samples were then transported by researchers to an internationally certified ISO 9001 labor laboratory for analysis of Na and K levels using the ion-selective electrode (ISE) method, which specifically responds to anions and cations. Urinary Na levels were categorized as low (< 100 mmol), normal (100-260 mmol), and high (> 260 mmol).

  3. Change in Serum Potassium Levels (mmol/L)

    Time frame: Baseline, Day 15

    Evaluation of changes in serum potassium levels as a response to dietary intake adjustments in the intervention group versus the control group. Serum potassium levels were determined through plasma blood testing using the ion-selective electrode (ISE) method. The samples were then transported by researchers to an internationally certified ISO 9001 laboratory. Plasma potassium levels were classified as follows: hypokalemia (< 3.5 mmol/L), normal (3.5-5 mmol/L), and hyperkalemia (> 5 mmol/L)

  4. Change in Plasma Nitric Oxide Levels (µmol/L)

    Time frame: Baseline, Day 15

    Measurement of plasma nitric oxide to assess vascular response to the dietary intervention.

  5. Change in Plasma F2-Isoprostane Levels (pmol/L)

    Time frame: Baseline, Day 15

    Analysis of changes in plasma F2-isoprostane as an oxidative stress marker to monitor the potential antioxidative effects of the dietary intervention.

  6. Change in Plasma Aldosterone Levels (pmol/L)

    Time frame: Baseline, Day 15

    Measurement of plasma aldosterone levels to assess any physiological changes associated with potassium and sodium intake adjustments.

  7. Change in Urinary Na/K Levels (mmol/L)

    Time frame: Baseline, Day 15

    The concentrations of sodium and potassium in urine were measured and expressed in millimoles per liter (mmol/L). The Na/K ratio in urine was calculated by dividing the sodium concentration by the potassium concentration. This ratio was used to evaluate the electrolyte balance in the study participants.

Sponsors and collaborators

Lead sponsor

Universitas Airlangga

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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