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Completed

NCT Number: NCT02959931

Postprandial Effects of a High Potassium Meal

The investigators aim to evaluate the acute effects of potassium supplementation achieved by ingestion of potassium rich food, on vascular health.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Potassium Meal

Other

Breakfast meal that provides ~2400 mg of dietary potassium. Meals are isocaloric.

Low Potassium Meal

Other

Breakfast meal that provides ~540 mg of potassium. Meals are isocaloric.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

Postprandial Physiological Effects of a High Potassium Meal in Patients With Hypertension

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 9, 2016
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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