Bioavailability of Potassium From Potatoes and Potassium Gluconate

NCT ID: NCT01881295

Last Updated: 2018-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-01

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Potassium Bioavailability Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo control

Subjects will consume tablets containing no potassium in addition to a basal diet containing 2336 mg potassium

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

Low dose potassium gluconate

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

Medium dose potassium gluconate

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

High dose potassium gluconate

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

Low dose potato

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

Medium dose potato

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

High dose potato

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

High dose French fries

Intervention Type DIETARY_SUPPLEMENT

Basal diet control

Subjects will consume a basal diet containing 2336 mg potassium daily

Group Type EXPERIMENTAL

Basal diet control

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Placebo control

Intervention Type DIETARY_SUPPLEMENT

Low dose potassium gluconate

Intervention Type DIETARY_SUPPLEMENT

Medium dose potassium gluconate

Intervention Type DIETARY_SUPPLEMENT

High dose potassium gluconate

Intervention Type DIETARY_SUPPLEMENT

Low dose potato

Intervention Type DIETARY_SUPPLEMENT

Medium dose potato

Intervention Type DIETARY_SUPPLEMENT

High dose potato

Intervention Type DIETARY_SUPPLEMENT

High dose French fries

Intervention Type DIETARY_SUPPLEMENT

Basal diet control

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alliance for Potato Research and Education

OTHER

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role lead

Responsible Party

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Berdine Martin

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Connie M Weaver, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Berdine R Martin, Ph.D.

Role: STUDY_DIRECTOR

Purdue University

Locations

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Purdue University

West Lafayette, Indiana, United States

Site Status

Countries

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United States

References

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Macdonald-Clarke CJ, Martin BR, McCabe LD, McCabe GP, Lachcik PJ, Wastney M, Weaver CM. Bioavailability of potassium from potatoes and potassium gluconate: a randomized dose response trial. Am J Clin Nutr. 2016 Aug;104(2):346-53. doi: 10.3945/ajcn.115.127225. Epub 2016 Jul 13.

Reference Type DERIVED
PMID: 27413123 (View on PubMed)

Other Identifiers

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1301013174

Identifier Type: -

Identifier Source: org_study_id

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