Postprandial Effects of a High Potassium Meal

NCT ID: NCT02959931

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-12-31

Brief Summary

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High potassium meal

In this arm individuals will be provided with a breakfast meal that provides \~2400 mg of dietary potassium.

Group Type: EXPERIMENTAL

High Potassium Meal

Intervention Type: OTHER

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

Low potassium meal

In this arm individuals will be provided with a breakfast meal that provides \~540 mg of dietary potassium.

Group Type: ACTIVE_COMPARATOR

Low Potassium Meal

Intervention Type: OTHER

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

Interventions

High Potassium Meal

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

Intervention Type: OTHER

Low Potassium Meal

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

MSH 13-0088-A

Identifier Type: -

Identifier Source: org_study_id