Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-03-02 @ 5:04 AM
Study NCT ID:
NCT03415568
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2018-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of MCDG Oil on Postprandial Lipid Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D015228', 'term': 'Hypertriglyceridemia'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2018-01-15', 'studyFirstSubmitQcDate': '2018-01-29', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Triglyceride levels', 'timeFrame': '6 hours', 'description': 'Triglyceride level differences during the 6-hr meal tolerance test between LCT and MCDG muffins intake'}], 'secondaryOutcomes': [{'measure': 'The areas under the curve (AUC) of triglycerides', 'timeFrame': '1 day of second visit (after finishing cross-over trial)', 'description': 'Triglyceride AUC differences between LCT and MCDG muffins intake'}, {'measure': 'Triglyceride maximum concentration time', 'timeFrame': '1 day of second visit (after finishing cross-over trial)', 'description': 'The time when triglyceride peaks maximum concentration during the 6-h meal tolerance test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postprandial lipid metabolism', 'Medium-chain triglycerides', 'Diacylglycerols', 'Serum triglycerides', 'Chylomicron triglycerides'], 'conditions': ['Hyperlipidemias', 'Triglycerides High']}, 'descriptionModule': {'briefSummary': 'It is well known that medium chain triglycerides (MCTs) and diacylglycerols (DGs) have effects on lowering circulating triglycerides (TGs). In this study, the mixture of MCTs and DGs (MCDGs) examined whether it has beneficial effects on postprandial lipids metabolism compared to long-chain triglycerides (TGs).', 'detailedDescription': 'A randomized, double-blinded, controlled, cross-over trial was conducted to verify the effects of MCDGs. Twenty-eight healthy male and female subjects aged 21-29 years with normal body weight \\[18.5 kg/m\\^2 ≤ body mass index (BMI) \\< 25 kg/m\\^2\\] were recruited. The subjects visited the research site twice over with a seven-day interval after an overnight fast at least 12 hr. On the first visit, the participants were randomly assigned to consume a test or placebo product \\[test product: muffins containing MCDG oil (MCDG muffin); placebo product: muffins containing LCT oil (LCT muffin)\\] and ingested the assigned product. On the second visit, the participants consumed the other product that they did not eat on the first visit. On both visit day, the 6-hr meal tolerance test was conducted and started at 8:00 in the morning; venous blood samples were collected before (0 hr) and after ingestion (2, 3, 4, and 6 hr) of the products.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects with normal body weight (18.5 kg/m\\^2 ≤ body mass index (BMI) \\< 25 kg/m\\^2)\n\nExclusion Criteria:\n\n* history/presence of hypertension, diabetes mellitus, hyperlipidemia, cardiovascular disease, liver disease, gastrointestinal disease, thyroid disease, or any other acute or chronic diseases requiring treatment\n* Use of any medication affecting body weight or energy expenditure for 1 month before screening'}, 'identificationModule': {'nctId': 'NCT03415568', 'briefTitle': 'Effects of MCDG Oil on Postprandial Lipid Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'The Effects of Functional Edible Oil (MCDG) on Reducing Body Fat of Overweight or Obesity Subjects (Part.2)', 'orgStudyIdInfo': {'id': 'DOP_OFTT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'LCT consumption', 'description': 'Muffin that contains 15g of long-chain triglyceride (LCT) oils were provided to conduct 6-h meal tolerance test.', 'interventionNames': ['Dietary Supplement: LCT oil']}, {'type': 'EXPERIMENTAL', 'label': 'MCDG consumption', 'description': 'Muffin that contains 15g of the mixture of medium-chain triglyceride and diacylglycerol (MCDG) oils were provided to conduct 6-h meal tolerance test.', 'interventionNames': ['Dietary Supplement: MCDG oil']}], 'interventions': [{'name': 'LCT oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'LCT muffin was provided to the study participants. The LCT muffin was consumed within 15 min, and then 6-h meal tolerance test was conducted. The muffin had approximately 465 kcal, 8.36 g of protein, 17.24 g of fat, and 69.0 g of carbohydrate; among the 17.24g of fat, 15g of fat was LCT.', 'armGroupLabels': ['LCT consumption']}, {'name': 'MCDG oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'MCDG muffin was provided to the study participants. The MCDG muffin was consumed within 15 min, and then 6-h meal tolerance test was conducted. The muffin had approximately 465 kcal, 8.36 g of protein, 17.24 g of fat, and 69.0 g of carbohydrate; among the 17.24g of fat, 15g of fat was MCDG.', 'armGroupLabels': ['MCDG consumption']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jong Ho Lee, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jong Ho Lee', 'investigatorAffiliation': 'Yonsei University'}}}}