Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2026-01-21 @ 7:42 PM
Study NCT ID:
NCT06511206
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2024-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C032418', 'term': '5,11-methenyltetrahydrohomofolate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2024-06-20', 'studyFirstSubmitQcDate': '2024-07-15', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Whole-body fat oxidation', 'timeFrame': 'Testday 1, 2, and 3', 'description': 'An exploratory outcome is the whole-body fat oxidation / substrate utilization determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as g/min and respiratory exchange ratio.'}, {'measure': 'Energy expenditure', 'timeFrame': 'Testday 1, 2, and 3', 'description': 'An exploratory outcome is the energy expenditure determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as kJ/min.'}, {'measure': 'Metabolites in the blood', 'timeFrame': 'Testday 1, 2, and 3', 'description': 'An exploratory outcome is the plasma metabolite levels determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as i.e. glucose in mmol/L, insulin in pmol/L.'}, {'measure': 'Interstitial ketone levels', 'timeFrame': 'Testday 1, 2, and 3', 'description': 'An exploratory outcome is the interstitial ketone levels determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as μM.'}], 'primaryOutcomes': [{'measure': 'Plasma ketone levels', 'timeFrame': 'Testday 1, 2, and 3', 'description': 'The primary outcome is plasma ketone levels determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as area under the curve (AUC).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'This study will be performed to determine the optimal nutrient mix (predominantly based on medium-chain triglycerides (MCTs)) to induce a mild ketogenic state in healthy older (60-80y), overweight/obese (BMI: 25-35 kg/m2) individuals. Since the aim is to induce a mild ketogenic state, a 25g MCT-based nutrient mix, a 25g MCT-based nutrient mix + cofactors, or a non-ketogenic control will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 60-80 years\n* Body mass index (BMI) 25-35 kg/m2\n* Stable dietary habits (no weight loss or gain \\> 5 kg in the past 3 months)\n* Participants are able to provide signed and dated written informed consent prior to any study specific procedures\n\nExclusion Criteria:\n\n* Type 2 diabetes\n* Pre-diabetes based on one or a combination of the following criteria:\n\n * ImpairedFastingGlucose(IFG):Fasting plasma glucose ≥ 6.1mmol/l and ≤ 6.9 mmol/l.\n * HbA1c of 5.7-6.4%.\n* Participants with active congestive heart failure and/or severe renal and or liver insufficiency\n* Uncontrolled hypertension\n* Alcohol consumption of \\> 3 servings per day for man and \\> 2 servings per day for woman\n* Unstable body weight (weight gain or loss \\> 5 kg in the last 3 months)\n* Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the investigator which would possibly hamper our study results\n* Significant food allergies/intolerance (seriously hampering study meals)\n* Participants who do not want to be informed about unexpected medical findings\n* Blood donation during or within 2 months prior to the study'}, 'identificationModule': {'nctId': 'NCT06511206', 'briefTitle': 'Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones', 'orgStudyIdInfo': {'id': 'NL86023.068.23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '25g MCT-based nutrient mix', 'interventionNames': ['Dietary Supplement: 25g MCT-based nutrient mix']}, {'type': 'EXPERIMENTAL', 'label': '25g MCT-based nutrient mix + cofactors', 'interventionNames': ['Dietary Supplement: 25g MCT-based nutrient mix + cofactors']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'non-ketogenic control', 'interventionNames': ['Dietary Supplement: non-ketogenic control']}], 'interventions': [{'name': '25g MCT-based nutrient mix', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The 25g MCT-based nutrient mix will be consumed two hours after breakfast.', 'armGroupLabels': ['25g MCT-based nutrient mix']}, {'name': '25g MCT-based nutrient mix + cofactors', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The 25g MCT-based nutrient mix + cofactors will be consumed two hours after breakfast.', 'armGroupLabels': ['25g MCT-based nutrient mix + cofactors']}, {'name': 'non-ketogenic control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The non-ketogenic control will be consumed two hours after breakfast.', 'armGroupLabels': ['non-ketogenic control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Joris Hoeks, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}