Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-27 @ 8:21 PM
Study NCT ID:
NCT05058157
Status:
UNKNOWN
Last Update Posted:
2023-10-17
First Post:
2021-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each testing cycle design will be either a complete or partial cross-over.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-16', 'studyFirstSubmitDate': '2021-09-16', 'studyFirstSubmitQcDate': '2021-09-16', 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae', 'timeFrame': '0 (baseline) to 4 hours after products consumption', 'description': 'Incremental area under the curve of total blood ketones'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Men and Women']}, 'descriptionModule': {'briefSummary': 'This research project aims at evaluating the effect of various ketone precursors and their formulations on blood ketone level after oral intake. Evaluation of the GI tolerability of the various formula will be also evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women, based on the screening visit and medical history,\n* BMI in the normal and overweight range 18.5 ≤ BMI ≤ 27;\n* Able to understand and sign informed consent form.\n\nExclusion Criteria:\n\n* Any medication possibly impacting the postprandial glucose and insulin response (based on anamnesis),\n* Any medication impacting dietary fat absorption and metabolism,\n* Pregnancy (on anamnesis) and/or lactation,\n* Known food allergy and food intolerance,\n* Individuals undergoing either dietary or exercise mediated weight loss program prescribed by a health care professional,\n* Individuals under ketogenic diets, or taking regular ketones products,\n* Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of bier,\n* Having given blood within the last month, or willing to make a blood donation until one month following the end of the study,\n* Family or hierarchical relationships with Clinical Innovation Lab at Nestlé Research, Lausanne, Switzerland,\n* Volunteer who cannot be expected to comply with the protocol,\n* Smokers unable to stop for the day of the visit.'}, 'identificationModule': {'nctId': 'NCT05058157', 'briefTitle': 'Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae', 'orgStudyIdInfo': {'id': '1803NR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ketone Precursor Formula 1', 'description': 'Formula 1 (in each cycle, up to 4 formula will be tested) Ketone precursors formula (powder to reconstitute in drinking water, or in a ready-to-drink format).', 'interventionNames': ['Dietary Supplement: different ketogenic formulae']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketone Precursor Formula 2', 'description': 'Ketone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format).', 'interventionNames': ['Dietary Supplement: different ketogenic formulae']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketone Precursor Formula 3', 'description': 'Ketone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format)', 'interventionNames': ['Dietary Supplement: different ketogenic formulae']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketone Precursor Formula 4', 'description': 'Ketone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format), or placebo', 'interventionNames': ['Dietary Supplement: different ketogenic formulae']}], 'interventions': [{'name': 'different ketogenic formulae', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The research product may be in a form of powder to reconstitute or in a ready-to-drink format.', 'armGroupLabels': ['Ketone Precursor Formula 1', 'Ketone Precursor Formula 2', 'Ketone Precursor Formula 3', 'Ketone Precursor Formula 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Nestlé Clinical Innovation Lab', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Pamela Sun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Société des Produits Nestlé (SPN)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}