Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-02-03 @ 10:13 AM
Study NCT ID:
NCT01881295
Status:
COMPLETED
Last Update Posted:
2018-05-09
First Post:
2013-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability of Potassium From Potatoes and Potassium Gluconate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-03', 'studyFirstSubmitDate': '2013-06-17', 'studyFirstSubmitQcDate': '2013-06-17', 'lastUpdatePostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioavailability of Potassium', 'timeFrame': '5 days', 'description': 'After 4 days of acclimation to the supplementation, absorption of potassium will be measured.'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure Response to Potassium', 'timeFrame': '6 days', 'description': 'Differences in blood pressure will be measured between levels of potassium consumption.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Potassium', 'Potato', 'French Fries', 'Bioavailability', 'Blood Pressure'], 'conditions': ['Potassium Bioavailability', 'Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '27413123', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to compare the effect of sources of potassium on uptake and the effect of potassium on blood pressure.', 'detailedDescription': '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).\n\nDuring 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to adhere to the visit schedule, protocol requirements and available to complete the study\n* Normotensive men and women\n* Aged 20-60 years\n* BMI of 15-35\n\nExclusion Criteria:\n\n* Medication to treat hypertension or hypotension\n* Medication known to affect electrolyte metabolism or contain high levels of potassium or sodium\n* smoke cigarettes or use illegal drugs\n* Hypertension or hypotension\n* Diseases known to affect potassium metabolism\n* Pregnant\n* Allergic to nuts'}, 'identificationModule': {'nctId': 'NCT01881295', 'acronym': 'Potato', 'briefTitle': 'Bioavailability of Potassium From Potatoes and Potassium Gluconate', 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'officialTitle': 'Bioavailability of Potassium From Potatoes and Potassium Gluconate', 'orgStudyIdInfo': {'id': '1301013174'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo control', 'description': 'Subjects will consume tablets containing no potassium in addition to a basal diet containing 2336 mg potassium', 'interventionNames': ['Dietary Supplement: Placebo control']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose potassium gluconate', 'description': 'Subjects will consume 720 mg potassium in the form of potassium gluconate tablets daily in addition to a basal diet containing 2336 mg potassium', 'interventionNames': ['Dietary Supplement: Low dose potassium gluconate']}, {'type': 'EXPERIMENTAL', 'label': 'Medium dose potassium gluconate', 'description': 'Subjects will consume 1440 mg potassium in the form of potassium gluconate tablets daily in addition to a basal diet containing 2336 mg potassium', 'interventionNames': ['Dietary Supplement: Medium dose potassium gluconate']}, {'type': 'EXPERIMENTAL', 'label': 'High dose potassium gluconate', 'description': 'Subjects will consume 2160 mg potassium in the form of potassium gluconate tablets daily in addition to a basal diet containing 2336 mg potassium', 'interventionNames': ['Dietary Supplement: High dose potassium gluconate']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose potato', 'description': 'Subjects will consume 720 mg potassium in the form of potato daily in addition to a basal diet containing 2336 mg potassium', 'interventionNames': ['Dietary Supplement: Low dose potato']}, {'type': 'EXPERIMENTAL', 'label': 'Medium dose potato', 'description': 'Subjects will consume 1440 mg potassium in the form of potato daily in addition to a basal diet containing 2336 mg potassium', 'interventionNames': ['Dietary Supplement: Medium dose potato']}, {'type': 'EXPERIMENTAL', 'label': 'High dose potato', 'description': 'Subjects will consume 2160 mg potassium in the form of potato daily in addition to a basal diet containing 2336 mg potassium', 'interventionNames': ['Dietary Supplement: High dose potato']}, {'type': 'EXPERIMENTAL', 'label': 'High dose French fries', 'description': 'Subjects will consume 2160 mg potassium in the form of french fries daily in addition to a basal diet containing 2336 mg potassium', 'interventionNames': ['Dietary Supplement: High dose French fries']}, {'type': 'EXPERIMENTAL', 'label': 'Basal diet control', 'description': 'Subjects will consume a basal diet containing 2336 mg potassium daily', 'interventionNames': ['Dietary Supplement: Basal diet control']}], 'interventions': [{'name': 'Placebo control', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo control']}, {'name': 'Low dose potassium gluconate', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Low dose potassium gluconate']}, {'name': 'Medium dose potassium gluconate', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Medium dose potassium gluconate']}, {'name': 'High dose potassium gluconate', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['High dose potassium gluconate']}, {'name': 'Low dose potato', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Low dose potato']}, {'name': 'Medium dose potato', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Medium dose potato']}, {'name': 'High dose potato', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['High dose potato']}, {'name': 'High dose French fries', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['High dose French fries']}, {'name': 'Basal diet control', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Basal diet control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47907', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Purdue University', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}], 'overallOfficials': [{'name': 'Connie M Weaver, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Purdue University'}, {'name': 'Berdine R Martin, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Purdue University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alliance for Potato Research and Education', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Berdine Martin', 'investigatorAffiliation': 'Purdue University'}}}}