Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-01 @ 10:36 PM
Study NCT ID:
NCT05411835
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2022-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Ketones and Exercise Among Patients With Long-chain Fatty Acid Oxidation Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C566945', 'term': 'Trifunctional Protein Deficiency With Myopathy And Neuropathy'}, {'id': 'C535589', 'term': 'Carnitine palmitoyl transferase 2 deficiency'}, {'id': 'C536353', 'term': 'VLCAD deficiency'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sachets of the ketone or maltodextrin powder are coded and packaged identically. The bionutrition unit will prepare the beverage and maintain the randomization code and the code for the ketone and maltodextrin products.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Subjects with either CPT2, TFP, LCHAD or VLCAD deficiency will be randomized to receive a ketone beverage (see composition in Appendix A) or an isocaloric maltodextrin control beverage (see composition in Appendix A) before moderate intensity exercise. Twenty minutes after consuming the pre-exercise beverage, subjects will complete a moderate intensity treadmill exercise test for 45 minutes. After a washout period of 48 hours, subjects will repeat the exercise. During the 2nd exercise test subjects will crossover to the beverage not consumed during the 1st exercise study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2022-05-27', 'studyFirstSubmitQcDate': '2022-06-06', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events- incidence', 'timeFrame': '2 hours after product intake', 'description': 'Number of Adverse events'}, {'measure': 'Adverse Events- type', 'timeFrame': '2 hours after product intake', 'description': 'Description of Adverse events: categorical'}, {'measure': 'Adverse Events- severity', 'timeFrame': '2 hours after product intake', 'description': 'Severity of adverse event: grade 1-5'}, {'measure': 'Adverse Events- causal relationship', 'timeFrame': '2 hours after product intake', 'description': 'Yes/No related to product intake'}, {'measure': 'Abdominal discomfort', 'timeFrame': '2 hours after product intake', 'description': 'visual analogue scale (VAS) 0-10'}, {'measure': 'Decreased appetite', 'timeFrame': '2 hours after product intake', 'description': 'visual analogue scale (VAS) 0-10'}, {'measure': 'Gastric reflux', 'timeFrame': '2 hours after product intake', 'description': 'visual analogue scale (VAS) 0-10'}, {'measure': 'Nausea', 'timeFrame': '2 hours after product intake', 'description': 'visual analogue scale (VAS) 0-10'}, {'measure': 'Diarrhea', 'timeFrame': '2 hours after product intake', 'description': 'visual analogue scale (VAS) 0-10'}, {'measure': 'Headache', 'timeFrame': '2 hours after product intake', 'description': 'visual analogue scale (VAS) 0-10'}], 'secondaryOutcomes': [{'measure': 'Blood Ketones', 'timeFrame': '20 minutes after moderate intensity exercise', 'description': 'plasma beta-hydroxybutyrate concentration'}, {'measure': 'Blood Creatine Kinase', 'timeFrame': '20 minutes after moderate intensity exercise', 'description': 'plasma CK concentration'}, {'measure': 'Blood Glucose', 'timeFrame': '20 minutes after moderate intensity exercise', 'description': 'serum glucose'}, {'measure': 'Blood Lactate', 'timeFrame': '20 minutes after moderate intensity exercise', 'description': 'serum lactate concentration'}, {'measure': 'Blood Pressure', 'timeFrame': 'peak 40 minute exercise', 'description': 'diastolic BP'}, {'measure': 'Blood Pressure', 'timeFrame': 'peak 40 minute exercise', 'description': 'systolic BP'}, {'measure': 'Perceived exertion', 'timeFrame': 'peak 40 minute exercise', 'description': 'Borg scale 1-20'}, {'measure': 'Respiratory Exchange Ratio', 'timeFrame': 'peak 40 minute exercise', 'description': 'VCO2/VO2 0.7 - 1.0'}, {'measure': 'Heart Rate', 'timeFrame': 'peak 40 minute exercise', 'description': 'beats per minute'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency', 'Carnitine Palmitoyltransferase Deficiency 2', 'Very Long Chain Acyl Coa Dehydrogenase Deficiency', 'Trifunctional Protein Deficiency']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if an oral ketone beverage is safe and well-tolerated during moderate intensity exercise in participants with long-chain fatty acid oxidation disorders and if it will raise blood ketones to levels similar to that reported among normal healthy subjects.', 'detailedDescription': 'Purpose: Subjects with long-chain fatty acid oxidation disorders (LC-FAOD) do not make ketones during fasting or with exercise. Ketones are an important alternative energy substrate during moderate exercise, sparing the oxidation of glucose and providing a source of ATP to the central nervous system and exercising muscle. Fatty acid oxidation in the liver is required to make ketones. Subjects with a LC-FAOD cannot generate ketones because of their block in fatty acid oxidation during exercise. Providing ketones in an oral ketone beverage may increase blood ketones with exercise to levels normally observed in humans.\n\nAim: To determine the safety and tolerability of an oral ketone beverage during moderate intensity exercise among subjects with a LC-FAOD compared to an isocaloric maltodextrin beverage, and to determine blood ketone concentrations.\n\nHypothesis: Oral consumption of a ketone beverage before moderate intensity exercise will be safe and well-tolerated, and will raise blood ketones among subjects with a LC-FAOD to concentrations similar to that reported in the literature among normal healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed diagnosis of VLCAD, LCHAD/TFP or CPT2 deficiency\n* speak English\n* willing to complete 2 moderate intensity exercise treadmills\n\nExclusion Criteria:\n\n* subjects actively participating in another research study that prohibits their participation\n* pregnant females\n* subjects with diabetes or taking medications to treat diabetes'}, 'identificationModule': {'nctId': 'NCT05411835', 'briefTitle': 'Oral Ketones and Exercise Among Patients With Long-chain Fatty Acid Oxidation Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Safety and Tolerability of Oral Ketones and Exercise Among Patients With Long-chain Fatty Acid Oxidation Disorders', 'orgStudyIdInfo': {'id': '23859'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nutrition Ketogenic Supplement', 'description': 'The Ketone pre-exercise beverage is a nutritional supplement. The supplement will be provided by Nestle as powered sachets to mix in water. It contains a mix of D-beta-hydroxybutyrate salts, flavors and stevia.', 'interventionNames': ['Dietary Supplement: Nutritional Ketone Supplement']}, {'type': 'SHAM_COMPARATOR', 'label': 'Isocaloric Placebo Supplement', 'description': 'The maltodextrin pre-exercise beverage is a nutritional supplement. The supplement will be provided by Nestle as powered sachets to mix in water. It contains an isocaloric amount of maltodextrin, flavors and stevia similar to the ketone beverage.', 'interventionNames': ['Dietary Supplement: Isocaloric Placebo Supplement']}], 'interventions': [{'name': 'Nutritional Ketone Supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['NKS'], 'description': 'Mix of sodium, calcium, and magnesium salts of D-beta-hydroxybutyrate with nicotinamide riboside chloride, flavors and stevia sweetener', 'armGroupLabels': ['Nutrition Ketogenic Supplement']}, {'name': 'Isocaloric Placebo Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Maltodextrin with flavors and stevia sweetener', 'armGroupLabels': ['Isocaloric Placebo Supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'The published manuscript will be available approximately 6-9 months after the conclusion of the study.', 'ipdSharing': 'YES', 'description': 'Participants will be provided with creatine kinase lab test and body composition measurement. The results of their creatine kinase lab test will be placed in their medical record. Results of the study will be written in a published manuscript and summarized in a cover letter to be sent via mail or email to the participant after publication of the data.', 'accessCriteria': 'not applicable. A reprint will be sent to participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Melanie B Gillingham', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}