NCT01881295

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 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

March 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

June 17, 2013

Last Update Submit

May 3, 2018

Conditions

Potassium BioavailabilityBlood Pressure

Keywords

PotassiumPotatoFrench FriesBioavailabilityBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • Bioavailability of Potassium

    After 4 days of acclimation to the supplementation, absorption of potassium will be measured.

    5 days

Secondary Outcomes (1)

  • Blood Pressure Response to Potassium

    6 days

Study Arms (9)

Placebo control

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo control

Low dose potassium gluconate

EXPERIMENTAL

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

Medium dose potassium gluconate

EXPERIMENTAL

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

High dose potassium gluconate

EXPERIMENTAL

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

Low dose potato

EXPERIMENTAL

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

Medium dose potato

EXPERIMENTAL

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

High dose potato

EXPERIMENTAL

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

High dose French fries

EXPERIMENTAL

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

Basal diet control

EXPERIMENTAL

Subjects will consume a basal diet containing 2336 mg potassium daily

Dietary Supplement: Basal diet control

Interventions

Placebo controlDIETARY_SUPPLEMENT
Placebo control
Low dose potassium gluconateDIETARY_SUPPLEMENT
Low dose potassium gluconate
Medium dose potassium gluconateDIETARY_SUPPLEMENT
Medium dose potassium gluconate
High dose potassium gluconateDIETARY_SUPPLEMENT
High dose potassium gluconate
Low dose potatoDIETARY_SUPPLEMENT
Low dose potato
Medium dose potatoDIETARY_SUPPLEMENT
Medium dose potato
High dose potatoDIETARY_SUPPLEMENT
High dose potato
High dose French friesDIETARY_SUPPLEMENT
High dose French fries
Basal diet controlDIETARY_SUPPLEMENT
Basal diet control

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

  • 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.

    PMID: 27413123DERIVED

Study Officials

  • Connie M Weaver, Ph.D.

    Purdue University

    PRINCIPAL INVESTIGATOR

  • Berdine R Martin, Ph.D.

    Purdue University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 19, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations

US(1)