Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-28 @ 4:37 PM
Study NCT ID:
NCT01527604
Status:
COMPLETED
Last Update Posted:
2014-11-19
First Post:
2012-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Avenanthramide-enriched Oats on Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-18', 'studyFirstSubmitDate': '2012-01-30', 'studyFirstSubmitQcDate': '2012-02-02', 'lastUpdatePostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in biomarkers of inflammation compared with placebo', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Primary outcome measures will include selected biomarkers of inflammation in blood, i.e., pro-inflammatory cytokines, chemokines, as well as other inflammatory markers (i.e., high sensitivity C-reactive protein).'}], 'secondaryOutcomes': [{'measure': 'Change in biomarkers of glucoregulation, plasma lipids, and blood pressure compared with placebo', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Secondary outcomes will include plasma markers of glucoregulation (fasting glucose, insulin, HOMA), plasma lipids (total cholesterol, HDL, LDL, triglycerides), and blood pressure (BP).'}]}, 'conditionsModule': {'conditions': ['Inflammation']}, 'descriptionModule': {'briefSummary': 'The objective of this randomized, double-blinded, placebo-controlled, parallel trial is to determine whether consuming avenanthramide-enriched oats daily for 8 weeks on can improve biomarkers of inflammation in older, obese adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men \\& postmenopausal women, age 50 years and over\n* BMI 30-36 kg/m2\n* waist:hip ratio \\> 0.8 for women, \\> 0.9 for men\n\nExclusion Criteria:\n\n* Cigarette smoking and/or nicotine replacement use\n* Individuals taking estrogen\n* Use of cholesterol-lowering medications\n* Use of blood pressure-lowering medications\n* Regular use of any stomach acid-lowering medications, laxatives (including fiber supplements) or anti-diarrheal medications(prescription or over-the-counter \\[OTC\\])\n* Cardiovascular (heart) disease\n* Gastrointestinal disease\n* Kidney disease\n* Endocrine disease: including diabetes, untreated thyroid disease\n* Rheumatoid arthritis\n* Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission\n* Systolic blood pressure \\> 150 mmHg and/or diastolic blood pressure \\> 95 mmHg\n* Regular use of oral steroids\n* Regular daily intake of ≥ 2 alcoholic drinks\n* Strict vegetarians\n* No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission"}, 'identificationModule': {'nctId': 'NCT01527604', 'briefTitle': 'Effects of Avenanthramide-enriched Oats on Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Tufts University'}, 'officialTitle': 'Effects of Avenanthramide-enriched Oats on Inflammation in Obese Adults With Central Adiposity: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'IRB9930'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Avenanthramide-enriched oat muffin', 'interventionNames': ['Other: Avenanthramide-enriched oats']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Refined flour muffin', 'interventionNames': ['Other: Refined flour absent avenanthramides']}], 'interventions': [{'name': 'Avenanthramide-enriched oats', 'type': 'OTHER', 'description': 'avenanthramide-enriched oats, delivered as muffins at a dose of 2 muffins per day for 56 days.', 'armGroupLabels': ['Avenanthramide-enriched oat muffin']}, {'name': 'Refined flour absent avenanthramides', 'type': 'OTHER', 'description': 'refined flour absent avenanthramides, delivered as muffins at a dose of 2 muffins per day for 56 days.', 'armGroupLabels': ['Refined flour muffin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Diane L. McKay, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agriculture and Agri-Food Canada', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}