HypertensionNCT06683430
High Potassium Diet with Spices and Herbs As Salt Substitute for Lowering Blood Pressure in Older Adults: Study Protocol
A study testing High Potassium, Low Sodium Diet and Standard Diet in people with Hypertension and Older Adults Institutionalized in Residential Homes, run by Universitas Airlangga at 1 site in Angola.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Older Adults Institutionalized in Residential Homes
- What is being tested?
- High Potassium, Low Sodium Diet and Standard Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteAngola
- Study dates
- 11 May 2022to 9 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Angola1 site
government institutional setting in Surabaya, Indonesia, namely Griya Wreda Surabaya nursing home.
Surabaya, Jawa Timur, 60232
About this study
Official 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
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.
- Being tested
- High Potassium, Low Sodium Diet, Standard Diet
- Keywords
- sodium, potassium, spices and herbs, blood pressure, hypertension, elderly, protocol study, gerontology, dietary, anti-hypertensive, oxidative stress
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Potassium, Low Sodium DietDietary supplement
Daily intake of 3500 mg K and 1500 mg Na for 14 days.
Standard DietDietary supplement
Daily intake of 1700 mg K and 2000 mg Na for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: High Potassium, Low Sodium Diet |
| 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. Receives: Dietary Supplement: Standard Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 8, and Day 15
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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)
Measured: Baseline, Day 15
Change in Plasma Nitric Oxide Levels (µmol/L)
Measurement of plasma nitric oxide to assess vascular response to the dietary intervention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start11 May 2022
- Primary completion30 Jun 2023
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Airlangga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farapti Farapti, Universitas Airlangga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683430
- Sponsor's protocol ID
- 35/EC/KEPK/FKUA/2023
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06683430
- Acronym / sponsor ID
- 35/EC/KEPK/FKUA/2023
- Keywords
- sodium, potassium, spices and herbs, blood pressure, hypertension, elderly, protocol study, gerontology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universitas AirlanggaUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group High Potassium, Low Sodium Diet | Active comparator | Dietary Supplement: High Potassium, Low Sodium DietParticipants 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 | Dietary Supplement: Standard DietParticipants received a standard diet with low potassium (1700 mg K) and high sodium (2000 mg Na) daily for 14 days. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Potassium, Low Sodium DietDaily intake of 3500 mg K and 1500 mg Na for 14 days. | Dietary supplement | Intervention Group High Potassium, Low Sodium Diet |
| Standard DietDaily intake of 1700 mg K and 2000 mg Na for 14 days. | Dietary supplement | Control Group Standard Diet (Low Potassium) |
Primary outcome
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.
7 secondary outcomes
Change in Urinary Potassium Levels (mmol)
Time frame: Baseline, Day 15
Change in Urinary Sodium Levels (mmol)
Time frame: Baseline, Day 15
Change in Serum Potassium Levels (mmol/L)
Time frame: Baseline, Day 15
Change in Plasma Nitric Oxide Levels (µmol/L)
Time frame: Baseline, Day 15
Change in Plasma F2-Isoprostane Levels (pmol/L)
Time frame: Baseline, Day 15
Change in Plasma Aldosterone Levels (pmol/L)
Time frame: Baseline, Day 15
Change in Urinary Na/K Levels (mmol/L)
Time frame: Baseline, Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Potassium, Low Sodium Diet and Standard Diet in people with Hypertension and Older Adults Institutionalized in Residential Homes, run by Universitas Airlangga at 1 site in Angola.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Angola. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Pressure (mmHg) (time frame: Baseline, Day 8, and Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.