Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-03-01 @ 6:11 AM
Study NCT ID:
NCT02376660
Status:
COMPLETED
Last Update Posted:
2015-03-03
First Post:
2015-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oats on Lipid Profile
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-25', 'studyFirstSubmitDate': '2015-02-25', 'studyFirstSubmitQcDate': '2015-02-25', 'lastUpdatePostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reduction of total cholesterol', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'LDL-c', 'timeFrame': '4 weeks'}, {'measure': 'Triglycerides', 'timeFrame': '4 weeks'}, {'measure': 'Blood pressure', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mildly Hypercholesterolemic Subjects']}, 'referencesModule': {'references': [{'pmid': '28376899', 'type': 'DERIVED', 'citation': 'Gulati S, Misra A, Pandey RM. Effects of 3 g of soluble fiber from oats on lipid levels of Asian Indians - a randomized controlled, parallel arm study. Lipids Health Dis. 2017 Apr 4;16(1):71. doi: 10.1186/s12944-017-0460-3.'}]}, 'descriptionModule': {'briefSummary': 'A randomized control trial to assess the effect of oats on lipid profile of mildly hypercholesterolemic subjects. Subjects consumed 35g of oats twice daily (total of 70g / day) in place of carbohydrates as part of their usual diet. 70 grams of oats provide 3 grams of soluble fiber. Control group consumed the usual diet. Subjects followed up for 4 weeks. In total 3 assessment visits of the subjects planned for the study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women between 20 and 50 years old\n* Total Cholesterol: ≥ 200 mg/dL and \\< 240mg/dL\n* Availability and willingness to follow study protocol\n* Stable body weight for previous 3 months (not more than 5% weight change)\n\nExclusion Criteria:\n\n* Subjects already on lipid lowering drugs\n* LDL-c \\> 190 mg/dL\n* Total cholesterol \\<200 mg/dL and \\>240 mg/dL\n* Subjects with serum creatinine levels \\> 1.3 mg/dL (female) or 1.4 mg/dL (male), nephropathy, evidence of hepatic disease or history of alcohol abuse\n* Baseline Triglycerides: \\> 300 mg/dL\n* Diabetes (Type 1 or Type 2) as diagnosed by a physician\n* Uncontrolled hyperthyroidism (as per physician's discretion)\n* Uncontrolled hypertension (as per physician's discretion)\n* Acute infections or chronic debilitating diseases like tuberculosis, malignancy, HIV infection etc. Any life threatening serious disorder of the liver, kidneys, heart, lungs or other organs by history\n* Irritable bowel syndrome by history\n* Unwillingness to give written informed consent for participation in the study.\n* Pregnancy \\& lactation (by history)\n* Severe end organ damage\n* Subjects with allergy to oats\n* Heavy smokers (smoking more than 5 cigarettes per day)"}, 'identificationModule': {'nctId': 'NCT02376660', 'briefTitle': 'Effect of Oats on Lipid Profile', 'organization': {'class': 'INDUSTRY', 'fullName': 'PepsiCo Global R&D'}, 'officialTitle': 'A Randomized Controlled Trial to Evaluate the Efficacy of 3 g of Soluble Fiber From Oats on the Lipid Profile of Men and Women With Elevated Lipid Levels Aged Between 20 and 50 Years', 'orgStudyIdInfo': {'id': 'PEP-1205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oats', 'description': '70 grams oats', 'interventionNames': ['Other: Oats']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'usual diet and exercise', 'description': 'usual diet and exercise'}], 'interventions': [{'name': 'Oats', 'type': 'OTHER', 'armGroupLabels': ['Oats']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anoop Misra, MD, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fortis Clinical Research Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PepsiCo Global R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}