- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02959931
Postprandial Effects of a High Potassium Meal
February 18, 2020 updated by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High potassium meal
In this arm individuals will be provided with a breakfast meal that provides ~2400 mg of dietary potassium.
|
Breakfast meal that provides ~2400 mg of dietary potassium.
Meals are isocaloric.
|
|
Active Comparator: Low potassium meal
In this arm individuals will be provided with a breakfast meal that provides ~540 mg of dietary potassium.
|
Breakfast meal that provides ~540 mg of potassium.
Meals are isocaloric.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
December 22, 2015
First Submitted That Met QC Criteria
November 7, 2016
First Posted (Estimate)
November 9, 2016
Study Record Updates
Last Update Posted (Actual)
February 20, 2020
Last Update Submitted That Met QC Criteria
February 18, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSH 13-0088-A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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