Bioavailability of Potassium From Potatoes and Potassium Gluconate

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the effect of sources of potassium on uptake and the effect of potassium on blood pressure.

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.

Official Title
-----------------
Bioavailability of Potassium From Potatoes and Potassium Gluconate

Conditions
-----------------
Potassium Bioavailability, Blood Pressure

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo control
* Dietary Supplement: Low dose potassium gluconate
* Dietary Supplement: Medium dose potassium gluconate
* Dietary Supplement: High dose potassium gluconate
* Dietary Supplement: Low dose potato
* Dietary Supplement: Medium dose potato
* Dietary Supplement: High dose potato
* Dietary Supplement: High dose French fries
* Dietary Supplement: Basal diet control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo control<br>Subjects will consume tablets containing no potassium in addition to a basal diet containing 2336 mg potassium | Dietary Supplement: Placebo control<br> <br> |
| Experimental: Low dose potassium gluconate<br>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<br> <br> |
| Experimental: Medium dose potassium gluconate<br>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<br> <br> |
| Experimental: High dose potassium gluconate<br>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<br> <br> |
| Experimental: Low dose potato<br>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<br> <br> |
| Experimental: Medium dose potato<br>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<br> <br> |
| Experimental: High dose potato<br>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<br> <br> |
| Experimental: High dose French fries<br>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<br> <br> |
| Experimental: Basal diet control<br>Subjects will consume a basal diet containing 2336 mg potassium daily | Dietary Supplement: Basal diet control<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability of Potassium | 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 | Differences in blood pressure will be measured between levels of potassium consumption. | 6 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Potassium, Potato, French Fries, Bioavailability, Blood Pressure