Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-03-03 @ 6:45 PM
Study NCT ID:
NCT05923593
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2023-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerance and Safety of an Oral Nutritional Supplement (Adolescent Cohort)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-16', 'studyFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2023-06-27', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of subjects who develop significant gastrointestinal adverse events (deemed probably related or related to study product as per investigator's opinion) leading to discontinuation of the study product and withdrawal from the study", 'timeFrame': 'Day 2 to Day 15', 'description': 'Number of subjects who develop significant gastrointestinal adverse events leading to discontinuation of the study product and withdrawal from the study'}], 'secondaryOutcomes': [{'measure': 'Severity of gastrointestinal intolerance symptoms', 'timeFrame': 'Day 1 to Day 15', 'description': 'Individual gastrointestinal symptom scores assessed by the Visual Analogue Scale (VAS) tool from 0 (no symptom) to 10 (maximum severity)'}, {'measure': 'Severity of gastrointestinal intolerance symptoms', 'timeFrame': 'Day 1 and Day 15', 'description': 'Individual gastrointestinal symptom scores assessed by the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire from No discomfort at all (no discomfort) to Very severe discomfort (maximum discomfort)'}, {'measure': 'Change in stool frequency', 'timeFrame': 'Day 1 to Day 15', 'description': 'Assessed by a questionnaire on daily number of stools'}, {'measure': 'Change in stool consistency', 'timeFrame': 'Day 1 to Day 15', 'description': 'Assessed by Bristol Stool Scale from stool consistency A (Separate hard lumps, like nuts, hard to pass) to G (Watery, no solid pieces)'}, {'measure': 'Change in weight', 'timeFrame': 'Day 1 and Day 15', 'description': 'Measured with a weight scale'}, {'measure': 'Change in BMI', 'timeFrame': 'Day 1 and Day 15', 'description': 'Measured with a weight scale and size scale'}, {'measure': 'Changes in lipid profile in the blood', 'timeFrame': 'Day 1 and Day 15', 'description': 'Triglycerides, cholesterol (total cholesterol, LDL cholesterol and HDL cholesterol) measured in plasma'}, {'measure': 'Changes in liver function tests in the blood', 'timeFrame': 'Day 1 and Day 15', 'description': 'ALAT measured in plasma'}, {'measure': 'Changes in liver function tests in the blood', 'timeFrame': 'Day 1 and Day 15', 'description': 'ASAT measured in plasma'}, {'measure': 'Changes in liver function tests in the blood', 'timeFrame': 'Day 1 and Day 15', 'description': 'phosphatase alkaline measured in plasma'}, {'measure': 'Changes in liver function tests in the blood', 'timeFrame': 'Day 1 and Day 15', 'description': 'Gamma glutamyl transferase measured in plasma'}, {'measure': 'Changes in liver function tests in the blood', 'timeFrame': 'Day 1 and Day 15', 'description': 'Total and direct bilirubin measured in plasma'}, {'measure': 'Changes in liver function tests in the blood', 'timeFrame': 'Day 1 and Day 15', 'description': 'Protein and albumin measured in plasma'}, {'measure': 'Changes in renal function tests in the blood', 'timeFrame': 'Day 1 and Day 15', 'description': 'Urea, creatinine measured in plasma'}, {'measure': 'Changes in blood chemistry tests', 'timeFrame': 'Day 1 and Day 15', 'description': 'C-Reactive Protein measured in serum'}, {'measure': 'Changes in blood chemistry tests', 'timeFrame': 'Day 1 and Day 15', 'description': 'Glucose measured in serum'}, {'measure': 'Changes in blood chemistry tests', 'timeFrame': 'Day 1 and Day 15', 'description': 'Sodium measured in serum'}, {'measure': 'Changes in blood chemistry tests', 'timeFrame': 'Day 1 and Day 15', 'description': 'Potassium measured in serum'}, {'measure': 'Changes in blood chemistry tests', 'timeFrame': 'Day 1 and Day 15', 'description': 'Calcium measured in serum'}, {'measure': 'Changes in blood chemistry tests', 'timeFrame': 'Day 1 and Day 15', 'description': 'Phosphate measured in serum'}, {'measure': 'Changes in blood chemistry tests', 'timeFrame': 'Day 1 and Day 15', 'description': 'Magnesium measured in serum'}, {'measure': 'Changes in blood chemistry tests', 'timeFrame': 'Day 1 and Day 15', 'description': 'Chloride measured in serum'}, {'measure': 'Daily intake of study product', 'timeFrame': 'Day 1 to Day 15', 'description': 'Number of participants adhering to daily intake of the study product assessed by a daily questionnaire'}, {'measure': 'Changes in full blood count', 'timeFrame': 'Day 1 and Day 15', 'description': 'thrombocyte count'}, {'measure': 'Changes in full blood count', 'timeFrame': 'Day 1 and Day 15', 'description': 'Erythrocyte count'}, {'measure': 'Changes in full blood count', 'timeFrame': 'Day 1 and Day 15', 'description': 'haemoglobin measured in blood'}, {'measure': 'Changes in full blood count', 'timeFrame': 'Day 1 and Day 15', 'description': 'haematocrit measured in blood'}, {'measure': 'Changes in full blood count', 'timeFrame': 'Day 1 and Day 15', 'description': 'mean cell hemoglobin concentation measured in Blood'}, {'measure': 'Changes in fatty acids profile', 'timeFrame': 'Day 1 and Day 15', 'description': 'Plasma and erythrocytes fatty acids profile'}, {'measure': 'Change in Vitamin A level', 'timeFrame': 'Day 1 and Day 15', 'description': 'Change in serum Vitamin A'}, {'measure': 'Change in 25-hydroxy vitamin D level', 'timeFrame': 'Day 1 and Day 15', 'description': 'Change in serum 25-hydroxy vitamin D'}, {'measure': 'Change in vitamin E level', 'timeFrame': 'Day 1 and Day 15', 'description': 'Change in serum vitamin E'}, {'measure': 'Changes in Vitamin K level', 'timeFrame': 'Day 1 and Day 15', 'description': 'change in international normalized ratio'}, {'measure': 'Changes in in fat-soluble vitamins', 'timeFrame': 'Day 1 and Day 15', 'description': 'Vitamin E/cholesterol ratio measured in plasma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '39681164', 'type': 'DERIVED', 'citation': 'Zemrani B, Krattinger LF, Giuffrida F, Corthesy J, Ran-Ressler RR, Benyacoub J. Safety and tolerability of Monoacylglycerol-rich oil as a novel predigested dietary fat source of an enteral formula in healthy adults and adolescents: Two single-arm, open-label studies. Clin Nutr ESPEN. 2025 Feb;65:339-347. doi: 10.1016/j.clnesp.2024.12.014. Epub 2024 Dec 15.'}]}, 'descriptionModule': {'briefSummary': 'This is an open label, non-randomized, interventional, single arm study.', 'detailedDescription': 'The primary objective is to assess whether the MAG oil-containing study formula is well tolerated and safe when used as an ONS in healthy adolescents.\n\nHypothesis: The study product will be safe and well tolerated in healthy adolescents (as previously observed in adults).\n\nSecondary objectives:\n\n1. Describe the frequency and characteristics of possible gastrointestinal intolerance symptoms\n2. Describe stool characteristics specifically stool frequency and consistency\n3. Describe changes in anthropometric parameters, particularly weight and body mass index (BMI)\n4. Describe changes in blood parameters of lipid metabolism\n5. Describe changes in hematological and serum biochemistry parameters\n6. Describe daily ONS intake and overall compliance'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy volunteers aged 12-17 years\n2. BMI range between the 10th and 90th percentile according to the Swiss growth charts with a minimum body weight of 40 kg.\n3. Deemed able to comply with study protocol for the study period\n4. Able to obtain written informed consent from participants and legally authorized representative(s)\n\nExclusion Criteria:\n\n1. Pre-existing chronic medical or psychiatric conditions.\n2. History of a chronic gastrointestinal disorder (e.g., inflammatory bowel disease, irritable bowel syndrome, celiac disease etc.), or chronic or recurrent gastrointestinal symptoms, including self-reported symptoms such as abdominal pain.\n3. Recent episode of an acute gastrointestinal illness with significant gastrointestinal symptoms in the 7 days prior to enrolment.\n4. History of chronic constipation (with passage of fewer than 3 spontaneous bowel movements per week on average or history of painful or hard bowel movements), OR chronic or intermittent diarrhea with loose or watery bowel movements ≥ 3 times per day.\n5. Colonoscopy or other bowel cleansing procedures within 4 weeks prior to enrolment.\n6. Prior use of prescription medication(s), in particular antibiotics, antiacids, laxatives, antidiarrheal agents or other medications impacting gastrointestinal transit time, within 3 weeks prior to enrolment.\n7. Significant medical or surgical event in the past 3 months potentially interfering with study procedures and assessments.\n8. Subjects following a weight loss program including a low-carbohydrate or low-fat diet, ketogenic diet, intermittent fasting, or any other special diet.\n9. Known food allergy in particular cow's milk protein allergy or known/suspected hypersensitivity or intolerance to any other ingredients in the study product. Subjects experiencing gastrointestinal symptoms when consuming dairy products or avoiding dairy in their diet should not participate in the study.\n10. Subjects taking energy or protein supplements.\n11. Known alcohol or substance abuse.\n12. Pregnant or lactating females or having given birth in the past 6 months prior to enrolment. Pregnancy will be ruled out by performing a standard urine dipstick test to female participants of childbearing potential prior to enrolment.\n13. Family or hierarchical relationships with Clinical Innovation Lab staff"}, 'identificationModule': {'nctId': 'NCT05923593', 'briefTitle': 'Tolerance and Safety of an Oral Nutritional Supplement (Adolescent Cohort)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Tolerance and Safety of an Oral Nutritional Supplement Containing Monoacylglycerol Oil (MAG Oil) as the Main Lipid Source in Healthy Adolescents', 'orgStudyIdInfo': {'id': '2214NR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral nutritional supplement', 'description': 'Oral nutritional supplement that contains MAG oil', 'interventionNames': ['Dietary Supplement: MAG oil oral nutritional supplement (ONS)']}], 'interventions': [{'name': 'MAG oil oral nutritional supplement (ONS)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The study product is suitable for use as an oral nutritional supplement (ONS).The study product contains MAG oil.', 'armGroupLabels': ['Oral nutritional supplement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Clinical Innovation Lab.', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Pamela Sun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neslté'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}