Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-03-01 @ 3:41 AM
Study NCT ID:
NCT04321018
Status:
UNKNOWN
Last Update Posted:
2020-03-25
First Post:
2020-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Mixed Macronutritional Meal With Medium Chain Triglycerides on the Oxidation of Postprandial Macronutrients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Crossover Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-prandial nutrient oxidation', 'timeFrame': '4 hours', 'description': 'Fat or carbohydrate oxidation measured by indrect calorimetry'}], 'secondaryOutcomes': [{'measure': 'Post-prandial blood glucose concentrations', 'timeFrame': '4 hours', 'description': 'Measures of blood glucose concentrations'}, {'measure': 'Post-prandial blood insulin concentrations', 'timeFrame': '4 hours', 'description': 'Measures of blood insulin concentrations'}, {'measure': 'Post-prandial blood non-esterified fatty acid concentrations', 'timeFrame': '4 hours', 'description': 'Measures of blood non-esterified fatty acid concentrations'}, {'measure': 'Post-prandial blood tryglicerides concentrations', 'timeFrame': '4 hours', 'description': 'Measures of blood tryglicerides concentrations'}, {'measure': 'Post-prandial blood cholesterol concentrations', 'timeFrame': '4 hours', 'description': 'Measures of blood cholesterol concentrations'}, {'measure': 'Post-prandial blood glycerol concentrations', 'timeFrame': '4 hours', 'description': 'Measures of blood glycerol concentrations'}, {'measure': 'Post-prandial blood lactate concentrations', 'timeFrame': '4 hours', 'description': 'Measures of blood lactate concentrations'}, {'measure': 'Post-prandial energy expenditure', 'timeFrame': '4 hours', 'description': 'Measured by indrect calorimetry'}, {'measure': 'Post-prandial sensations related to appetite', 'timeFrame': '4 hours', 'description': 'Measured by visual analogue scales (VAS). Score ranging from 0 to 100mm. Higher values mean the most positive rating, while lower values mean the most negative rating.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The main aim of this study is to determine the effect of the addition of medium chain triglycerides to a mixed macro nutritional meal on postprandial macronutrients oxidation (i.e. fat oxidation, carbohydrate oxidation, change in respiratory quotient, peak respiratory quotient, etc.).', 'detailedDescription': 'A mixed meal characterized by a high quantity of carbohydrates could develop an increment in the postprandial carbohydrate oxidation. Medium chain triglycerides could be absorbed and metabolized immediately. It is plausible that its addition to a mixed meal unchains the decrement in the carbohydrate oxidation and increment in fat oxidation. If this hypothesis it is correct, its lower postprandial carbohydrate oxidation could develop a higher postprandial exposure to hyperglycemia, being of clinical interest.\n\n20 young adults will be randomized into two conditions (experimental and control conditions) with 7 days of separation between conditions. Each evaluation day will conform to the following tests:\n\n1. Basal metabolic rate assessment through indirect calorimetry.\n2. Intake of the corresponding mixed meal (experimental or control)\n3. Postprandial nutrient oxidation and energy expenditure through indirect calorimetry\n4. Blood samples assessment in 9 time points during the evaluation day.\n5. Post-prandial sensations related to appetite in 11 time points during the evaluation day'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male or female\n* Ages 18-30 years\n* BMI: 18-27.5 kg/m2\n* Stable weight over the last 3 months (body weight changes\\<35kg)\n* Participant must be capable and willing to provide consent, understand exclusion criteria, instructions and protocols.\n\nExclusion Criteria:\n\n* History of cardiovascular disease\n* Diabetes or hypertension\n* Pregnant, planning to become pregnant, or breastfeeding\n* Have been treated previously or during the study period with prescription drugs: antihypertensive, lipid lowering, acid uric lowering, glucose lowering, beta blockers or any drug that under the investigator's judged could influence the results.\n* Hematological pathology\n* Have had a blood transfusion or severe blood loss within the last 3 months\n* Allergy/intolerance to milk proteins, fish, soy, and/or any ingredient of the mixed meal\n* Any non-controlled medical condition which could influence results or could be worsened by the participation in the study\n* Claustrophobia\n* Needle phobia\n* Are deemed unsuitable by the investigator for any other reason, that prevent data collection."}, 'identificationModule': {'nctId': 'NCT04321018', 'briefTitle': 'Effect of a Mixed Macronutritional Meal With Medium Chain Triglycerides on the Oxidation of Postprandial Macronutrients', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Effect of the Addition of Medium Chain Triglycerides to a Mixed Macronutritional Meal on the Oxidation of Postprandial Macronutrients', 'orgStudyIdInfo': {'id': 'nº 1102/CEIH/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meal with medium chain triglycerdies first', 'description': 'Arm 1: participants randomized to receive the mixed meal with medium chain triglycerides first.', 'interventionNames': ['Dietary Supplement: Mixed meal with medium chain triglycerides', 'Dietary Supplement: Mixed meal with the replacement of medium chain triglycerides with unsaturated tryglicerides']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Meal with medium chain triglycerdies second', 'description': 'Arm 2: participants randomized to receive the mixed meal without medium chain triglycerides first.te', 'interventionNames': ['Dietary Supplement: Mixed meal with medium chain triglycerides', 'Dietary Supplement: Mixed meal with the replacement of medium chain triglycerides with unsaturated tryglicerides']}], 'interventions': [{'name': 'Mixed meal with medium chain triglycerides', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Mixed macronutrient liquid meal (1.6kcal/ml, 15% protein, 47% carbohydrates, 35% fat, 3% fiber) with medium chain triglycerides (3g/100 kcal). An amount with energy supply equivalent to their 50% basal metabolic rate.', 'armGroupLabels': ['Meal with medium chain triglycerdies first', 'Meal with medium chain triglycerdies second']}, {'name': 'Mixed meal with the replacement of medium chain triglycerides with unsaturated tryglicerides', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Mixed macronutrient liquid meal (1.6kcal/ml, 15% protein, 47% carbohydrates, 35% fat, 3% fiber) without medium chain triglycerides (replaced it with long chain triglycerides). An amount with energy supply equivalent to their 50% basal metabolic rate.', 'armGroupLabels': ['Meal with medium chain triglycerdies first', 'Meal with medium chain triglycerdies second']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18011', 'city': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jonatan Ruiz Ruiz, Dr', 'role': 'CONTACT', 'email': 'ruizj@ugr.es'}, {'name': 'Lucas Jurado Fasoli, PhD student', 'role': 'CONTACT', 'email': 'juradofasoli@ugr.es'}], 'facility': 'Jonatan Ruiz Ruiz', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'centralContacts': [{'name': 'Jonatan Ruiz Ruiz, Dr.', 'role': 'CONTACT', 'email': 'ruizj@ugr.es', 'phone': '958242754', 'phoneExt': '34'}, {'name': 'Lucas Jurado Fasoli, PhD student', 'role': 'CONTACT', 'email': 'juradofasoli@ugr.es'}], 'overallOfficials': [{'name': 'Jonatan Ruiz Ruiz, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Granada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jonatan Ruiz Ruiz', 'investigatorAffiliation': 'Universidad de Granada'}}}}