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

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• Hypertension 6,689

Keywords

• sodium
• potassium
• spices and herbs
• blood pressure
• hypertension
• elderly
• protocol study
• gerontology
• dietary
• anti-hypertensive
• oxidative stress

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 62 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Lead sponsor

Universitas Airlangga is the lead sponsor of 21 studies on the registry; 5 are open to participants now.

Study arms

• Active comparator
  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.

  Dietary Supplement: High Potassium, Low Sodium Diet

• Placebo comparator
  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.

  Dietary Supplement: Standard Diet

Interventions

• Dietary supplementHigh Potassium, Low Sodium Diet

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

• Dietary supplementStandard Diet

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

Primary outcomes

1. Change in Blood Pressure (mmHg)

   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.

   Time frame: Baseline, Day 8, and Day 15

Secondary outcomes

1. Change in Urinary Potassium Levels (mmol)

   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).

   Time frame: Baseline, Day 15

2. Change in Urinary Sodium Levels (mmol)

   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).

   Time frame: Baseline, Day 15

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

   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)

   Time frame: Baseline, Day 15

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

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

   Time frame: Baseline, Day 15

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

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

   Time frame: Baseline, Day 15

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

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

   Time frame: Baseline, Day 15

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

   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.

   Time frame: Baseline, Day 15

Individual participant data

Plan to share: No