HypertensionNCT02959931
Postprandial Effects of a High Potassium Meal
A study testing High Potassium Meal and Low Potassium Meal in people with Hypertension, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
The investigators aim to evaluate the acute effects of potassium supplementation achieved by ingestion of potassium rich food, on vascular health. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- High Potassium Meal and Low Potassium Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Dec 2014
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years
- Normal sinus rhythm
- A diagnosis of hypertension on medical therapy with an ambulatory systolic blood pressure <160 mmHg and diastolic blood pressure <90 mmHg, or a diagnosis of stable coronary artery disease
Who cannot join
- Recent hospital admission due to an cardiovascular events
- Serum K+ concentration >5.0 mmol/L
- Current smoking
- Women who are pregnant
- Diabetic patients - patients receiving insulin therapy
- Glomerular filtration rate < 90mls/min/1.73m2
- On loop diuretic therapy
- Food allergies and/or intolerance to meal items
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postprandial Physiological Effects of a High Potassium Meal in Patients With Hypertension
The investigators aim to evaluate the acute effects of potassium supplementation achieved by ingestion of potassium rich food, on vascular health.
Read the detailed description
Many studies have shown that an increase in potassium through the diet or through potassium pills helps to lower blood pressure. Also, the amount of oral potassium taken can improve how well the participants blood vessels work. These studies have focused on potassium given in the form of a pill. The investigators are interested in the effect of potassium consumed through food sources and how it will effect arterial health and blood pressure. The world health organization (WHO) recommends a K⁺ intake of at least 3510 mg/day from food for adults, excluding those with impaired K⁺ excretion. In this study the investigators aim to provide approximately 75% (approximately 2000 mg) of the total daily recommended intake for potassium in one meal. The investigators do not know whether dietary potassium (not pill form) will acutely improve the arterial health and if it will cause a decrease in blood pressure. The investigators hypothesis to see an improvement in vascular function following a high potassium meal compared to a low potassium meal.
- Conditions
- Hypertension
- Being tested
- High Potassium Meal, Low Potassium Meal
- Keywords
- Dietary Potassium
- 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 MealOther
Breakfast meal that provides ~2400 mg of dietary potassium. Meals are isocaloric.
Low Potassium MealOther
Breakfast meal that provides ~540 mg of potassium. Meals are isocaloric.
| Study group | Role | What they receive |
|---|---|---|
| High potassium meal | Experimental | In this arm individuals will be provided with a breakfast meal that provides ~2400 mg of dietary potassium. Receives: Other: High Potassium Meal |
| Low potassium meal | Active comparator | In this arm individuals will be provided with a breakfast meal that provides ~540 mg of dietary potassium. Receives: Other: Low Potassium Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Flow Mediated Dilatation
Flow Mediated Dilatation is a method used to measure endothelial-dependent regulation of conduit artery tone(Joannides R, 1995).
Measured: Flow Mediated Dilatation will be assessed over 2 clinic visits, at 3 times points with in each visit; pre-prandial and post-prandial at 60 min and 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2014
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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959931
- Sponsor's protocol ID
- MSH 13-0088-A
- Status last verified
- Feb 2020
- First submitted
- 22 Dec 2015
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Physiological Effects of a High Potassium Meal in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT02959931
- Acronym / sponsor ID
- MSH 13-0088-A
- Conditions
- Hypertension
- Keywords
- Dietary Potassium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Nov 2016 (estimated)
- 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.
The investigators aim to evaluate the acute effects of potassium supplementation achieved by ingestion of potassium rich food, on vascular health.
Detailed description
Many studies have shown that an increase in potassium through the diet or through potassium pills helps to lower blood pressure. Also, the amount of oral potassium taken can improve how well the participants blood vessels work. These studies have focused on potassium given in the form of a pill. The investigators are interested in the effect of potassium consumed through food sources and how it will effect arterial health and blood pressure. The world health organization (WHO) recommends a K⁺ intake of at least 3510 mg/day from food for adults, excluding those with impaired K⁺ excretion. In this study the investigators aim to provide approximately 75% (approximately 2000 mg) of the total daily recommended intake for potassium in one meal. The investigators do not know whether dietary potassium (not pill form) will acutely improve the arterial health and if it will cause a decrease in blood pressure. The investigators hypothesis to see an improvement in vascular function following a high potassium meal compared to a low potassium meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High potassium meal | Experimental | Other: High Potassium MealIn this arm individuals will be provided with a breakfast meal that provides ~2400 mg of dietary potassium. |
| Low potassium meal | Active comparator | Other: Low Potassium MealIn this arm individuals will be provided with a breakfast meal that provides ~540 mg of dietary potassium. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-80 years
- Normal sinus rhythm
- A diagnosis of hypertension on medical therapy with an ambulatory systolic blood pressure <160 mmHg and diastolic blood pressure <90 mmHg, or a diagnosis of stable coronary artery disease
Key exclusion criteria (8 listed)
- Recent hospital admission due to an cardiovascular events
- Serum K+ concentration >5.0 mmol/L
- Current smoking
- Women who are pregnant
- Diabetic patients - patients receiving insulin therapy
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 MealBreakfast meal that provides ~2400 mg of dietary potassium. Meals are isocaloric. | Other | High potassium meal |
| Low Potassium MealBreakfast meal that provides ~540 mg of potassium. Meals are isocaloric. | Other | Low potassium meal |
Primary outcome
Change in Flow Mediated Dilatation
Time frame: Flow Mediated Dilatation will be assessed over 2 clinic visits, at 3 times points with in each visit; pre-prandial and post-prandial at 60 min and 120 min
Flow Mediated Dilatation is a method used to measure endothelial-dependent regulation of conduit artery tone(Joannides R, 1995).
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 20 Feb 2020.
- 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 Meal and Low Potassium Meal in people with Hypertension, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 3 inclusion and 8 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 20 Feb 2020. 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 Canada. 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. 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 Flow Mediated Dilatation (time frame: Flow Mediated Dilatation will be assessed over 2 clinic visits, at 3 times points with in each visit; pre-prandial and post-prandial at 60 min and 120 min). 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 20 Feb 2020.