Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-23 @ 1:10 AM
Study NCT ID:
NCT01698294
Status:
COMPLETED
Last Update Posted:
2022-05-09
First Post:
2012-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Post-Menopausal Women Receiving Flaxseed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}, {'id': 'D008043', 'term': 'Linseed Oil'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 258}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-06', 'studyFirstSubmitDate': '2012-09-04', 'studyFirstSubmitQcDate': '2012-09-28', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative percent of Eubacteria composition from quantitative polymerase chain reaction (qPCR) associated with lignan levels', 'timeFrame': 'Up to week 21'}, {'measure': 'Steroid hormone and lignans levels after exposure to a lignan-rich food (flaxseed)', 'timeFrame': 'Up to week 21'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gut microbiome', 'hormones', 'women', 'race', 'phytoestrogens'], 'conditions': ['No Evidence of Disease']}, 'referencesModule': {'references': [{'pmid': '35261959', 'type': 'DERIVED', 'citation': "McCann SE, Rodriguez EM, Erwin D, Yao S, Tritchler D, Hullar MAJ, O'Connor T, Lampe JW. Recruitment and Retention of Healthy, Postmenopausal Women of African and European Ancestry: Results from a Dietary Intervention with Repeated Biospecimen Collections. Curr Dev Nutr. 2022 Jan 29;6(3):nzac012. doi: 10.1093/cdn/nzac012. eCollection 2022 Mar."}]}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial studies biomarkers in post-menopausal women receiving flaxseed. Studying samples of blood, urine, and feces in the laboratory from participants receiving flaxseed may help doctors understand the effects of flaxseed on biomarkers.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine associations between the composition of the gut bacterial communities and baseline levels of the mammalian lignans and steroid hormones.\n\nII. To determine how variation in gut microbial community composition and in steroid hormone and xenobiotic metabolizing genes affects the metabolism of mammalian lignans and steroid hormones after exposure to a lignan-rich food (flaxseed).\n\nIII. To determine how these associations differ by race (i.e., African American and European American women).\n\nOUTLINE: Participants are randomized to 1 of 2 treatment groups.\n\nGROUP I: Participants receive flaxseed orally (PO) daily for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group II.\n\nGROUP II: Participants maintain a usual diet for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group I.\n\nAfter completion of study treatment, participants are followed up for 30 days.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure\n* Participant must be a non-Hispanic white or non-Hispanic black (self-reported race) woman 45 to 80 years of age and postmenopausal; postmenopausal will be defined as no menstrual cycle in the past 12 months; women with a hysterectomy but with intact ovaries will be included if aged \\>= 55 years\n* Willingness to comply with the requirements of the study\n\nExclusion Criteria:\n\n* Unwilling or unable to follow protocol requirements\n* Self-reported race other than non-Hispanic white or non-Hispanic black\n* Use, in the 2 months prior to week 1 visit, of antibiotics, hormone replacement therapy, nonprescription hormones or herbal supplements for menopausal symptoms, or flaxseed supplements\n* Nut or seed allergy\n* Self-reported inflammatory bowel disease\n* Gastric bypass\n* Use of thyroid replacement medication (Synthroid or similar) for \\< 1 year\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive flaxseed\n* Chemotherapy/radiation within the past year\n* Body weight greater than 400 pounds (limit of Tanita scale)"}, 'identificationModule': {'nctId': 'NCT01698294', 'briefTitle': 'Biomarkers in Post-Menopausal Women Receiving Flaxseed', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'A Pilot Study of the Flaxseed Effects on Hormones and Lignans: Role of Race, Genes, and Gut Microbiome', 'orgStudyIdInfo': {'id': 'I 216812'}, 'secondaryIdInfos': [{'id': 'NCI-2012-01246', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'I 216812', 'type': 'OTHER', 'domain': 'Roswell Park Cancer Institute'}, {'id': 'U01CA161809', 'link': 'https://reporter.nih.gov/quickSearch/U01CA161809', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (flaxseed)', 'description': 'Participants receive flaxseed PO daily for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group II.', 'interventionNames': ['Dietary Supplement: Flaxseed', 'Other: Laboratory Biomarker Analysis', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (usual diet)', 'description': 'Participants maintain a usual diet for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group I.', 'interventionNames': ['Other: Clinical Observation', 'Other: Laboratory Biomarker Analysis', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Clinical Observation', 'type': 'OTHER', 'description': 'Participants maintain usual diet and undergo clinical observation', 'armGroupLabels': ['Group II (usual diet)']}, {'name': 'Flaxseed', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['FLAX SEED', 'Flour, Flaxseed', 'Linseed'], 'description': 'Given PO', 'armGroupLabels': ['Group I (flaxseed)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Group I (flaxseed)', 'Group II (usual diet)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (flaxseed)', 'Group II (usual diet)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Spencer Rosario, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, {'name': 'University of Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}