NCT02959931

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2015

Completed
11 months until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

December 22, 2015

Last Update Submit

February 18, 2020

Conditions

Hypertension

Keywords

Dietary Potassium

Outcome Measures

Primary Outcomes (1)

  • Change in Flow Mediated Dilatation

    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

Study Arms (2)

High potassium meal

EXPERIMENTAL

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

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.

Other: Low Potassium Meal

Interventions

High Potassium MealOTHER

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

High potassium meal
Low Potassium MealOTHER

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

Low potassium meal

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2015

First Posted

November 9, 2016

Study Start

June 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)