Postprandial Effects of a High Potassium Meal

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

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

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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