Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:28 PM
Study NCT ID:
NCT01428960
Status:
COMPLETED
Last Update Posted:
2013-10-31
First Post:
2011-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Acute Effects of Sn-1 and Sn-3 Palmitic Acid-rich or Stearic Acid-rich Fats on Metabolic Markers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-30', 'studyFirstSubmitDate': '2011-08-26', 'studyFirstSubmitQcDate': '2011-09-02', 'lastUpdatePostDateStruct': {'date': '2013-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glucose-dependent insulintropic polypeptide (GIP)', 'timeFrame': '4 hours'}], 'secondaryOutcomes': [{'measure': 'Lipid profile', 'timeFrame': '4 hours'}, {'measure': 'Inflammatory markers', 'timeFrame': '4 hours'}, {'measure': 'Haemostatic indices', 'timeFrame': '4 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Palm mid fraction', 'Shea butter', 'sn-1, sn-3 fatty acids', 'Cholesterol', 'Postprandial lipemia,', 'Inflammatory markers', 'Satiety', 'Gut hormone', 'Insulin'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To determine the effect of degree of fat saturation on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety perceptions, and insulinemic responses in healthy adult subjects.\n\nStudy hypothesis: The degree of fat saturation does not affect postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, insulinemic or satiety responses in health adult subjects.', 'detailedDescription': 'The experimental are comprise of 50g fat, 14g protein and 84g carbohydrate. Each of the test fat \\[palm mid fraction (PMF), shea butter (SB) and high oleic sunflower oil (HOSF)\\] will be compared which will be in a form of experimental meals (muffin).\n\n33 volunteers receives 3 experimental meals (muffins) in a random order, 2 week apart, over a 6-week period. They will be randomized, blinded and will undergo a 3x3 arms crossover. The first 15-ml ("0" min) fasting venous blood samples is obtained. Immediately thereafter, the subject consumes the test meal plus a glass of water within 15 minutes. The time sequence is started mid-way of consuming the test meal.\n\nAt 30 min, 60 min, 90, 120 min (2 hr), 150 min and 180 min (3 hr), 210 min, and 240 min (4 hr), 15-ml each of blood is collected (via a vascular catheter inserted earlier in the subjects hand/arm).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adult male or female staff, aged between 25-50 years\n2. BMI 18.5 - 25.0 kg/m2\n3. Blood pressure: Systolic: \\<140 mmHg, diastolic: \\<90 mmHg\n\nc. Normolipidemic (Total cholesterol \\<6.2 mM/L (\\<240 mg/dL), Fasting TG \\<1.70 mM/L (\\<150 mg/dL) d. Fasting glucose 4.0- 7.0 mM/L\n\nExclusion Criteria:\n\n1. Smokers\n2. On cholesterol or blood glucose medication\n3. Substance abuse (eg. alcohol, cigarette smoking)\n4. For women, pregnant or lactating\n5. Going overseas during period of study\n6. Blood clotting problem\n7. Public transportation to work'}, 'identificationModule': {'nctId': 'NCT01428960', 'briefTitle': 'Study of Acute Effects of Sn-1 and Sn-3 Palmitic Acid-rich or Stearic Acid-rich Fats on Metabolic Markers', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Malaysia Palm Oil Board'}, 'officialTitle': 'Acute Effects of Sn-1 and Sn-3 Palmitic Acid-rich or Stearic Acid-rich Fats on Postprandial Lipemia, Haemostatic and Inflammatory Markers, Gut Hormone Concentrations, Satiety, and Insulinemic Response in Human Volunteers', 'orgStudyIdInfo': {'id': 'IMU R 069/2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Palm Mid Fraction', 'interventionNames': ['Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil']}, {'type': 'EXPERIMENTAL', 'label': 'Shea Butter', 'interventionNames': ['Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil']}, {'type': 'EXPERIMENTAL', 'label': 'High Oleic Sunflower Oil', 'interventionNames': ['Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil']}], 'interventions': [{'name': 'Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['POP vs SOS vs OOO'], 'description': 'Acute effect of sn-1 and sn-3 palmitic acid-rich or stearic acid-rich fats on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety, and insulinemic response in human volunteers ; 6 wk each with 2 week wash out in between', 'armGroupLabels': ['High Oleic Sunflower Oil', 'Palm Mid Fraction', 'Shea Butter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43000', 'city': 'Kajang', 'state': 'Selangor', 'country': 'Malaysia', 'facility': 'Malaysian Palm Oil Board Kajang, Selangor,', 'geoPoint': {'lat': 2.99424, 'lon': 101.78875}}], 'overallOfficials': [{'name': 'Tony Ng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IMU University, Malaysia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Malaysia Palm Oil Board', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'IMU University, Malaysia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}