Hypertension, Older Adults Institutionalized in Residential Homes
Conditions
Keywords
sodium, potassium, spices and herbs, blood pressure, hypertension, elderly, protocol study, gerontology, dietary, anti-hypertensive, oxidative stress
Brief summary
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.
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.
Sponsors
Universitas Airlangga
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Pressure (mmHg) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinary Sodium Levels (mmol) | 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). |
| Change in Serum Potassium Levels (mmol/L) | 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) |
| Change in Plasma Nitric Oxide Levels (µmol/L) | Baseline, Day 15 | Measurement of plasma nitric oxide to assess vascular response to the dietary intervention. |
| Change in Urinary Potassium Levels (mmol) | 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). |
| Change in Plasma Aldosterone Levels (pmol/L) | Baseline, Day 15 | Measurement of plasma aldosterone levels to assess any physiological changes associated with potassium and sodium intake adjustments. |
| Change in Urinary Na/K Levels (mmol/L) | 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. |
| Change in Plasma F2-Isoprostane Levels (pmol/L) | 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. |
Countries
Angola
Outcome results
None listed