Bioavailability of Potassium From Potatoes and Potassium Gluconate (Potato)

May 3, 2018 updated by: Berdine Martin, Purdue University
This study is designed to compare the effect of sources of potassium on uptake and the effect of potassium on blood pressure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will compare uptake of potassium from three different doses and sources; supplements (720, 1440 and 2160 mg) potatoes (720, 1440 and 2160 mg) or French fries (2160 mg).

During 9 phases, participants will consume a controlled diet with the supplements, potato or french fries (every other week for 5 days). On the 4th day, blood and urine samples will be taken to monitor potassium uptake and excretion. Measures of blood pressure will be analyzed at defined time points throughout the intervention.

Study Type

Interventional

Enrollment (Actual)

45

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

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Purdue University

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to adhere to the visit schedule, protocol requirements and available to complete the study
  • Normotensive men and women
  • Aged 20-60 years
  • BMI of 15-35

Exclusion Criteria:

  • Medication to treat hypertension or hypotension
  • Medication known to affect electrolyte metabolism or contain high levels of potassium or sodium
  • smoke cigarettes or use illegal drugs
  • Hypertension or hypotension
  • Diseases known to affect potassium metabolism
  • Pregnant
  • Allergic to nuts

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo control
Subjects will consume tablets containing no potassium in addition to a basal diet containing 2336 mg potassium
Dietary supplement: Placebo control
Experimental: Low dose potassium gluconate
Subjects will consume 720 mg potassium in the form of potassium gluconate tablets daily in addition to a basal diet containing 2336 mg potassium
Dietary supplement: Low dose potassium gluconate
Experimental: Medium dose potassium gluconate
Subjects will consume 1440 mg potassium in the form of potassium gluconate tablets daily in addition to a basal diet containing 2336 mg potassium
Dietary supplement: Medium dose potassium gluconate
Experimental: High dose potassium gluconate
Subjects will consume 2160 mg potassium in the form of potassium gluconate tablets daily in addition to a basal diet containing 2336 mg potassium
Dietary supplement: High dose potassium gluconate
Experimental: Low dose potato
Subjects will consume 720 mg potassium in the form of potato daily in addition to a basal diet containing 2336 mg potassium
Dietary supplement: Low dose potato
Experimental: Medium dose potato
Subjects will consume 1440 mg potassium in the form of potato daily in addition to a basal diet containing 2336 mg potassium
Dietary supplement: Medium dose potato
Experimental: High dose potato
Subjects will consume 2160 mg potassium in the form of potato daily in addition to a basal diet containing 2336 mg potassium
Dietary supplement: High dose potato
Experimental: High dose French fries
Subjects will consume 2160 mg potassium in the form of french fries daily in addition to a basal diet containing 2336 mg potassium
Dietary supplement: High dose French fries
Experimental: Basal diet control
Subjects will consume a basal diet containing 2336 mg potassium daily
Dietary supplement: Basal diet control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioavailability of Potassium
Time Frame: 5 days
After 4 days of acclimation to the supplementation, absorption of potassium will be measured.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure Response to Potassium
Time Frame: 6 days
Differences in blood pressure will be measured between levels of potassium consumption.
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Collaborators

Alliance for Potato Research and Education

Investigators

  • Principal Investigator: Connie M Weaver, Ph.D., Purdue University
  • Study Director: Berdine R Martin, Ph.D., Purdue University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1301013174

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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