Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-02 @ 7:34 PM
Study NCT ID:
NCT03452761
Status:
COMPLETED
Last Update Posted:
2018-03-02
First Post:
2018-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exogenous Ketones in Healthy Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007662', 'term': 'Ketosis'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Supplemental packets were not labeled except with the code A or B - placed by the supplement laboratory. PI notified of groups after completion.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double-blinded, 2-groups (condition and placebo)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-01', 'studyFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2018-03-01', 'lastUpdatePostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood health parameters', 'timeFrame': '6 weeks on the supplement', 'description': 'Comprehensive Metabolic Panel'}, {'measure': 'Blood health parameter', 'timeFrame': '6 weeks on the supplement', 'description': 'Complete blood count'}, {'measure': 'Blood health parameter', 'timeFrame': '6 weeks on the supplement', 'description': 'Lipid Panel'}, {'measure': 'Blood health parameter', 'timeFrame': '6 weeks on the supplement', 'description': 'Insulin'}, {'measure': 'Blood ketone levels', 'timeFrame': 'Baseline and 6 weeks after chronic consumption', 'description': 'Blood ketones assessed 30- and 60 minutes after consuming the supplement'}, {'measure': 'Cardiovascular', 'timeFrame': '6 weeks on the supplement', 'description': 'Blood Pressure'}, {'measure': 'Body Composition', 'timeFrame': '6 weeks on the supplement', 'description': 'Skinfold measure'}, {'measure': 'Body Composition', 'timeFrame': '6 weeks on the supplement', 'description': 'Weight'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exogenous ketone salts', 'ketosis', 'safety', 'comprehensive metabolic panel', 'complete blood count', 'lipid panel', 'insulin'], 'conditions': ['Healthy Young Adults']}, 'descriptionModule': {'briefSummary': 'Exogenous ketone supplements in the form of beta-hydroxybutyrate can be utilized as an alternate energy source (in place of glucose) for all cells except red blood cells. Exogenous ketone administration has been shown to be beneficial in terms of reducing oxidative stress, improving neuronal energy supplies, and maintaining normal blood glucose levels. The purpose of this study is to determine the effects and safety of supplementing with exogenous ketones for 6-weeks in healthy college-aged males and females. The results of this proposed study will determine whether exogenous ketone supplementation can be useful in promoting better body composition, energy levels, and blood cholesterol, glucose, and insulin levels.', 'detailedDescription': 'A total of 22 subjects, male and female, were randomized to either a ketone salt group or a placebo group. Both the participants and investigators were blinded, as the supplements were coded by an external lab. Data was collected at baseline and again in 6-weeks. Participants consumed 2 servings of the assigned supplement daily for 6 weeks. Measures included body composition, blood pressure, questionnaires, blood work (comprehensive metabolic panel, complete blood count, and lipid panel), and a urinalysis. Also, blood ketone levels were assessed before and periodically after consuming the supplemental drink (30 and 60 minutes post drink). These measures were performed at both baseline and 6-weeks later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy (no known conditions)\n\nExclusion Criteria:\n\n* Chronic smoker Pregnant'}, 'identificationModule': {'nctId': 'NCT03452761', 'briefTitle': 'Effects of Exogenous Ketones in Healthy Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Augusta University'}, 'officialTitle': 'Effects of Exogenous Ketones in Healthy Young Adults', 'orgStudyIdInfo': {'id': '10414835'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ketone Salts', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Exogenous Ketone Salts, Pruvit Keto OS'], 'description': 'Subjects will take 2 servings of ketone salts daily for 6 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All data will be deidentified'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Funding source: Pruvit Ventures, Inc', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Angelia Holland', 'investigatorAffiliation': 'Augusta University'}}}}