Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-04-24 @ 11:38 PM
Study NCT ID:
NCT02599103
Status:
COMPLETED
Last Update Posted:
2015-11-06
First Post:
2015-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Various Cooking Oils on Health Related Biomarkers in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069463', 'term': 'Olive Oil'}, {'id': 'D013024', 'term': 'Soybean Oil'}, {'id': 'D000073878', 'term': 'Palm Oil'}, {'id': 'C013698', 'term': 'tallow'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-05', 'studyFirstSubmitDate': '2015-09-15', 'studyFirstSubmitQcDate': '2015-11-05', 'lastUpdatePostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The changs of metabolomics profile between before and after oil consumption', 'timeFrame': 'baseline to 2 hours and 4 hours after oil consumption', 'description': 'This is a metabolomics study. We measured retention time (min), mass and abundance of serum metabolites with LC-QTOF at 3 time points. Then, we compared the abundance of metabolites between different oil consumption time ( before and after ) and assessed the health effects of cooking oils.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colorectal Neoplasms']}, 'descriptionModule': {'briefSummary': 'Fats and oils play important roles in maintaining human nutrition and health through providing energy, essential fatty acids, and acting as modulators of many biological processes (signal transduction, immunity and inflammation). Due to differences in the fatty acid composition and content of antioxidants of individual cooking oils, the degree of oxidative and thermolytic reactions may vary oil by oil. It is lack of human feeding study to investigate the molecular mechanisms on how and which deep-fried oil exerts its adverse effects. The investigators are also lack of biomarkers for monitoring deep-fried oil exposure. Therefore, the purpose of this study is to compare how human body responds differently to several popular uncooked and deep-fried oils with varied fatty acid compositions with respect of oxylipin profile, inflammatory markers, non-targeted metabolomics, and transcriptomics. The investigators will recruit 20 volunteers, provided them once a week the milk shakes prepared from 60g of olive oil, soybean oil, palm oil, camellia oil, tallow (butter), and deep-fried oils of the last 4, respectively; in comparison with a no-fat milk shake control. The experiments lasted for 10 weeks.。Each time; serum, plasma, whole blood and urine samples were collected at baseline, after 2 hours, and after 4 hours. The investigators anticipate to find biomarker(s) for deep-frying, and contribute to the understanding of molecular mechanisms on how deep-fried oils exert adverse effects toward health through integrative omics or so-called system biology approaches.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-smoking, non-drinker, usual dietary intake\n* BMI : 18.5\\~27 kg/m2\n\nExclusion Criteria:\n\n1. Over the past two weeks have suffered from acute illness.\n2. None of the subjects was taking any supplemental vitamins, antioxidants or medication at that time.\n3. Taking steroids or non-steroidal anti-inflammatory drug, such as Aspirin or Panadol in the past one week.\n4. Cancer or other severe diseases was diagnosed.'}, 'identificationModule': {'nctId': 'NCT02599103', 'briefTitle': 'The Effects of Various Cooking Oils on Health Related Biomarkers in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Academia Sinica, Taiwan'}, 'orgStudyIdInfo': {'id': 'AS-IRB02-102083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'fat-free milkshake', 'interventionNames': ['Other: Fat-free milkshake']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Olive oil', 'interventionNames': ['Other: Olive oil']}, {'type': 'EXPERIMENTAL', 'label': 'soybean oil', 'interventionNames': ['Other: Soybean oil']}, {'type': 'EXPERIMENTAL', 'label': 'fried soybean oil', 'interventionNames': ['Other: Fried soybean oil']}, {'type': 'EXPERIMENTAL', 'label': 'palm oil', 'interventionNames': ['Other: Palm oil']}, {'type': 'EXPERIMENTAL', 'label': 'fried palm oil', 'interventionNames': ['Other: Fried palm oil']}, {'type': 'EXPERIMENTAL', 'label': 'camellia oil', 'interventionNames': ['Other: Camellia oil']}, {'type': 'EXPERIMENTAL', 'label': 'fried camellia oil', 'interventionNames': ['Other: Fried camellia oil']}, {'type': 'EXPERIMENTAL', 'label': 'tallow', 'interventionNames': ['Other: Tallow']}, {'type': 'EXPERIMENTAL', 'label': 'fried tallow', 'interventionNames': ['Other: Fried tallow']}], 'interventions': [{'name': 'Fat-free milkshake', 'type': 'OTHER', 'description': 'participants drinks a fat-free milk shakes', 'armGroupLabels': ['fat-free milkshake']}, {'name': 'Olive oil', 'type': 'OTHER', 'description': 'participants drinks the milk shakes prepared from 60g of olive oil', 'armGroupLabels': ['Olive oil']}, {'name': 'Soybean oil', 'type': 'OTHER', 'description': 'participants drinks the milk shakes prepared from 60g of soybean oil', 'armGroupLabels': ['soybean oil']}, {'name': 'Fried soybean oil', 'type': 'OTHER', 'description': 'participants drinks the milk shakes prepared from 60g of fried soybean oil', 'armGroupLabels': ['fried soybean oil']}, {'name': 'Palm oil', 'type': 'OTHER', 'description': 'participants drinks the milk shakes prepared from 60g of palm oil', 'armGroupLabels': ['palm oil']}, {'name': 'Fried palm oil', 'type': 'OTHER', 'description': 'participants drinks the milk shakes prepared from 60g of fried palm oil', 'armGroupLabels': ['fried palm oil']}, {'name': 'Camellia oil', 'type': 'OTHER', 'description': 'participants drinks the milk shakes prepared from 60g of camellia oil', 'armGroupLabels': ['camellia oil']}, {'name': 'Fried camellia oil', 'type': 'OTHER', 'description': 'participants drinks the milk shakes prepared from 60g of fried camellia oil', 'armGroupLabels': ['fried camellia oil']}, {'name': 'Tallow', 'type': 'OTHER', 'description': 'participants drinks the milk shakes prepared from 60g of tallow', 'armGroupLabels': ['tallow']}, {'name': 'Fried tallow', 'type': 'OTHER', 'description': 'participants drinks the milk shakes prepared from 60g of fried tallow', 'armGroupLabels': ['fried tallow']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Wen-Harn Pan, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Biomedical Sciences, Academia Sinica'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academia Sinica, Taiwan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Institute of Biomedical Sciences', 'investigatorFullName': 'Wen-Harn Pan', 'investigatorAffiliation': 'Academia Sinica, Taiwan'}}}}