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Bioavailability of Potassium From Potatoes and Potassium Gluconate

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Purdue University
Sponsor:
Collaborator:
Alliance for Potato Research and Education (APRE)
Information provided by (Responsible Party):
Purdue University
ClinicalTrials.gov Identifier:
NCT01881295
First received: June 17, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

This study is designed to compare the effect of sources of potassium on uptake and the effect of potassium on blood pressure.


Condition Intervention
Potassium Bioavailability
Blood Pressure
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Bioavailability of Potassium From Potatoes and Potassium Gluconate

Resource links provided by NLM:


Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Bioavailability of Potassium [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    After 4 days of acclimation to the supplementation, absorption of potassium will be measured.


Secondary Outcome Measures:
  • Blood Pressure Response to Potassium [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    Differences in blood pressure will be measured between levels of potassium consumption.


Estimated Enrollment: 35
Study Start Date: March 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881295

Contacts
Contact: Berdine R Martin, Ph.D. 765-494-6559 bmartin1@purdue.edu
Contact: Claire J Macdonald-Clarke, Ph.D. 765-494-7625 macdonc@purdue.edu

Locations
United States, Indiana
Purdue University Recruiting
West Lafayette, Indiana, United States, 47907
Contact: Berdine R Martin, Ph.D.    765-494-6559    bmartin1@purdue.edu   
Sponsors and Collaborators
Purdue University
Alliance for Potato Research and Education (APRE)
Investigators
Principal Investigator: Connie M Weaver, Ph.D. Purdue University
Study Director: Berdine R Martin, Ph.D. Purdue University
  More Information

No publications provided

Responsible Party: Purdue University
ClinicalTrials.gov Identifier: NCT01881295     History of Changes
Other Study ID Numbers: 1301013174
Study First Received: June 17, 2013
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
Potassium
Potato
French Fries
Bioavailability
Blood Pressure

ClinicalTrials.gov processed this record on September 22, 2014