Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group High Potassium, Low Sodium Diet | Active Comparator | Participants received a diet enriched with potassium (3500 mg K) and reduced sodium (1500 mg Na) for 14 days. |
|
| Control Group Standard Diet (Low Potassium) | Placebo Comparator | Participants received a standard diet with low potassium (1700 mg K) and high sodium (2000 mg Na) daily for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Potassium, Low Sodium Diet | Dietary Supplement | Daily intake of 3500 mg K and 1500 mg Na for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 8, and Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| government institutional setting in Surabaya, Indonesia, namely Griya Wreda Surabaya nursing home. | Surabaya | Jawa Timur | 60232 | Angola |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard Diet | Dietary Supplement | Daily intake of 1700 mg K and 2000 mg Na for 14 days. |
|
| Baseline, Day 15 |
| 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). | Baseline, Day 15 |
| 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) | Baseline, Day 15 |
| Change in Plasma Nitric Oxide Levels (µmol/L) | Measurement of plasma nitric oxide to assess vascular response to the dietary intervention. | Baseline, Day 15 |
| 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. | Baseline, Day 15 |
| Change in Plasma Aldosterone Levels (pmol/L) | Measurement of plasma aldosterone levels to assess any physiological changes associated with potassium and sodium intake adjustments. | Baseline, Day 15 |
| 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. | Baseline, Day 15 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004039 | Diet, Sodium-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided