Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
Study NCT ID:
NCT04211766
Status:
COMPLETED
Last Update Posted:
2024-09-27
First Post:
2019-11-20
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004043', 'term': 'Dietary Fiber'}, {'id': 'D005395', 'term': 'Fish Oils'}], 'ancestors': [{'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'JLampe@fredhutch.org', 'phone': '(206) 667-6580', 'title': 'Dr. Johanna Lampe', 'organization': 'Fred Hutchinson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This is a pilot study with limited funding (R21 mechanism) thus sample size is small.'}}, 'adverseEventsModule': {'timeFrame': 'Only during study participation (4 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Cross-over Randomization 1: Fiber Plus Fish Oil Followed by Comparator', 'description': 'Period 1: participants receive fiber supplement and fish oil supplements PO daily on days 1-30.\n\nWashout: at least 60 days. Period 2: participants receive the comparators supplements also PO daily on days 90-120.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cross-over Randomization 2: Comparator Followed by Fiber Plus Fish Oil', 'description': 'Period 1: participants receive the comparators supplements PO daily on days 1-30.\n\nWashout: at least 60 days. Period 2: participants receive fiber supplement and fish oil supplements also PO daily on days 90-120.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility and Retention for a Trial With Daily Doses of 35 g of Fiber and 6.2 g of EPA +DHA (and Corresponding Comparators)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cross-over Randomization 1: Fiber Plus Fish Oil Followed by Comparator', 'description': 'Period 1: participants receive fiber supplement and fish oil supplement PO daily on days 1-30.\n\nWashout: at least 60 days. Period 2: participants receive the comparators supplements also PO daily on days 90-120.'}, {'id': 'OG001', 'title': 'Cross-over Randomization 2: Comparator Followed by Fiber Plus Fish Oil', 'description': 'For Period 1: participants receive comparator supplements PO daily on days 1-30.\n\nParticipants enter a washout period for at least 60 days. For Period 2: participants receive fiber supplement and fish oil supplement also PO daily on days 90-120.'}], 'classes': [{'categories': [{'title': 'Participants with complete measures (who completed Period 1 and Period 2)', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Participants with partial measures (who only completed Period 1)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Participants who dropped out during Period 1', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Participants who dropped out during Period 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to completion of the 2 study time periods', 'description': 'This grant is an R21 with the intent to provide preliminary data to propose a trial with a larger sample size and adequate statistical power.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who consented and started the intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Differentially Expressed Exfoliome Genes at p<0.01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'genes', 'counts': [{'value': '1000', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exfoliome Differentially Expressed (DE) Gene Analysis', 'description': 'Fiber plus fish oil supplementation vs comparator (based on end of treatment timepoints).'}], 'classes': [{'title': 'Upregulated', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Downregulated', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Unchanged', 'categories': [{'measurements': [{'value': '988', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Fiber Plus Fish Oil Supplementation vs end of Comparator', 'description': 'Poly A+ RNA was isolated from exfoliated cells in stool, and libraries generated from stool RNA and sequenced on an Illumina HiSeq 2500 platform. Intestinal exfoliome gene sequencing data from the end of each intervention period were analyzed using differential expression (DE) analysis. Count data were aligned, and sample libraries were filtered and normalized; 25,118 detected features were filtered to keep any feature with \\>20 cpm in 73% of samples in at least one of the groups; this resulted in 1000 genes. DE analysis between Fiber Plus Fish Oil Supplement vs the Comparator at the end time point was performed using edgeR with a paired design (Robinson et al, Bioinformatics 2010;26:139). Data are presented as number of DE genes significant at p \\< 0.01 (without multiple test correction). Upregulated genes indicate higher gene expression with Fiber Plus Fish Oil vs the Comparator and downregulated genes indicate lower gene expression with Fiber Plus Fish Oil vs the Comparator.', 'unitOfMeasure': 'number of genes at p<0.01', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'genes', 'denomUnitsSelected': 'genes', 'populationDescription': 'All participants who completed both the Fiber Plus Fish Oil Supplement and the Comparator intervention periods in this crossover study and had stools at the end of each intervention period were included in the analysis. RNA-Seq data from stool for 29 participants were analyzed for differential gene expression comparing the end of each intervention period.'}, {'type': 'SECONDARY', 'title': 'Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber Plus Fish Oil Supplements', 'description': 'Daily Fiber plus Fish oil supplements (regardless of cross-over randomization order)'}, {'id': 'OG001', 'title': 'Comparator', 'description': 'Daily comparator supplements'}], 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'spread': '29.7', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average at the end of each intervention period', 'description': 'Serum Phospholipids - Eicosapentaenoic acid (EPA), concentration', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cross-over Randomization 1: Fiber Plus Fish Oil Followed by Comparator', 'description': 'Period 1: Fiber and Fish oil supplements (30 days) Washout: at least 60 days Period 2: Comparator supplements (30 days)'}, {'id': 'FG001', 'title': 'Cross-over Randomization 2: Comparator Followed by Fiber Plus Fish Oil', 'description': 'Period 1: Comparator supplements (30 days) Washout: at least 60 days Period 2: Fiber and Fish oil supplements (30 days)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Completed Only Period 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'comment': 'This total does not include the participants that only completed only study Period 1 and dropped out during the washout. The 2 participants who dropped out during the washout have partial measures (blood and stools) that may be included in some of the statistical analysis.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment occurred December 2020 thru March 2022 via ads, fliers and social media in the Seattle area. We received 243 screening questionnaires; 88 were incomplete. Of 155 completed, 95 were ineligible (61.3%). We contacted the 60 eligible; 43 attended orientation; 38 signed consent. Three were not randomized (2 ineligible based on abnormal clinical lab tests at baseline and 1 withdrew because of stool collection). Overall, we met planned recruitment goals.', 'preAssignmentDetails': 'Before randomization to determine the crossover order of supplements (active-washout-comparison, or comparison-washout-active), consented participants had a blood draw. Samples were sent to CLIA-certified Quest Labs for kidney/liver function tests as part of eligibility criteria. Two of the 38 were ineligible based on the lab test criteria. Additionally, 1 person decided they did not want to enter the trial and was not randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cross-over Randomization 1: Fiber Plus Fish Oil Followed by Comparator', 'description': 'Participants received a fiber supplement and fish oil supplement PO daily for 30 days. After a washout period, of at least 60 days, they received the comparator supplements (also for 30 days)'}, {'id': 'BG001', 'title': 'Cross-over Randomization 2: Comparator Followed by Fiber Plus Fish Oil', 'description': 'Participants received the comparator supplements PO daily for 30 days. After a washout period, of at least 60 days, they received the fiber supplement and fish oil supplement (also for 30 days)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '64.9', 'spread': '5.3', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '6.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-20', 'size': 1727072, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-10T18:35', 'hasProtocol': True}, {'date': '2020-10-29', 'size': 846159, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-19T19:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-24', 'studyFirstSubmitDate': '2019-11-20', 'resultsFirstSubmitDate': '2023-08-10', 'studyFirstSubmitQcDate': '2019-12-23', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-22', 'studyFirstPostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility and Retention for a Trial With Daily Doses of 35 g of Fiber and 6.2 g of EPA +DHA (and Corresponding Comparators)', 'timeFrame': 'Baseline to completion of the 2 study time periods', 'description': 'This grant is an R21 with the intent to provide preliminary data to propose a trial with a larger sample size and adequate statistical power.'}], 'secondaryOutcomes': [{'measure': 'Number of Differentially Expressed Exfoliome Genes at p<0.01', 'timeFrame': 'End of Fiber Plus Fish Oil Supplementation vs end of Comparator', 'description': 'Poly A+ RNA was isolated from exfoliated cells in stool, and libraries generated from stool RNA and sequenced on an Illumina HiSeq 2500 platform. Intestinal exfoliome gene sequencing data from the end of each intervention period were analyzed using differential expression (DE) analysis. Count data were aligned, and sample libraries were filtered and normalized; 25,118 detected features were filtered to keep any feature with \\>20 cpm in 73% of samples in at least one of the groups; this resulted in 1000 genes. DE analysis between Fiber Plus Fish Oil Supplement vs the Comparator at the end time point was performed using edgeR with a paired design (Robinson et al, Bioinformatics 2010;26:139). Data are presented as number of DE genes significant at p \\< 0.01 (without multiple test correction). Upregulated genes indicate higher gene expression with Fiber Plus Fish Oil vs the Comparator and downregulated genes indicate lower gene expression with Fiber Plus Fish Oil vs the Comparator.'}, {'measure': 'Compliance', 'timeFrame': 'Average at the end of each intervention period', 'description': 'Serum Phospholipids - Eicosapentaenoic acid (EPA), concentration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colon', 'Rectum'], 'conditions': ['Healthy Subject']}, 'descriptionModule': {'briefSummary': 'This trial studies how fiber and fish oil supplements affect the metabolism and activities of colon cells in healthy individuals. Diet is an important risk factor for colorectal cancer, and several dietary components important in colorectal cancer prevention are modified by gut microbial metabolism. Giving fiber and fish oil supplements may inhibit the growth of gut cells and ultimately reduce risk of colorectal cancer.', 'detailedDescription': 'Participants are randomized to receive two dietary interventions in assigned random order. They either receive the dietary fiber supplement and fish oil supplement orally (PO) daily or they receive a fiber control and corn oil supplement daily for 30 days during the first intervention period. Then they enter a washout period for 60 days when they do not receive any treatment. After that they complete the second intervention period during which they receive the other intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Normal-overweight (body mass index \\[BMI\\] of 18-30 kg/m\\^2)\n* Women will be postmenopausal, with no menstrual period in 12 months\n* Non-smoking\n* Consume fiber intakes of less than \\< 20 g/d\n* White blood cell count 3,000-11,000/mm\\^3\n* Platelet count 100,000-400,000 mm\\^3\n* Hematocrit 33-50% (women); 36-50% (men)\n* Bilirubin 0.2-1.3 mg/dL\n* Aspartate aminotransferase (AST) 0-35 U/L\n* Alanine aminotransferase (ALT) 0-40 U/L\n* Alkaline phosphatase 20-125 U/L\n* Creatinine =\\< 1.2 mg/dL\n* Potassium 3.5-5.0 mmol/L\n\nExclusion Criteria:\n\n* Chronic medical illness, history of gastrointestinal disorders (e.g., ulcerative colitis, Crohn disease, celiac sprue, hereditary nonpolyposis colorectal cancer \\[HNPCC\\], familial adenomatous polyposis, pancreatic disease, previous gastrointestinal resection, radiation or chemotherapy, and cancer (other than non-melanoma skin cancer)\n* Weight change greater than 4.5 kg within past year\n* Oral or intravenous (IV) antibiotic use within the past 3 months\n* Regular use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)\n* Smoking or use of cannabis products\n* Known allergy to fish\n* Intention to relocate out of study area within next 4 months'}, 'identificationModule': {'nctId': 'NCT04211766', 'briefTitle': 'Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Diet and the Colonic Exfoliome: A Novel, Non-Invasive Approach to Testing Interventions in Humans', 'orgStudyIdInfo': {'id': 'RG1006100'}, 'secondaryIdInfos': [{'id': 'NCI-2019-07435', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'RG1006100', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}, {'id': 'R21CA245456', 'link': 'https://reporter.nih.gov/quickSearch/R21CA245456', 'type': 'NIH'}, {'id': '10327', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cross-over Randomization 1: Fiber plus Fish Oil followed by Comparator', 'description': 'Participants first received a fiber supplement and a fish oil supplement PO daily for 30 days (Period 1). Participants entered a washout period for at least 60 days. For period 2 they received similarly packaged comparator (maltodextrin and corn oil)', 'interventionNames': ['Dietary Supplement: Dietary Fiber', 'Dietary Supplement: Fish Oil', 'Other: Comparator']}, {'type': 'EXPERIMENTAL', 'label': 'Cross-over Randomization 2: Comparator followed by Fiber plus Fish Oil', 'description': 'Participants first received the comparator (maltodextrin and corn oil) supplement PO daily for 30 days (Period 1). Participants enter a washout period for at least 60 days. For period 2 they received the fiber supplement and a fish oil supplement', 'interventionNames': ['Dietary Supplement: Dietary Fiber', 'Dietary Supplement: Fish Oil', 'Other: Comparator']}], 'interventions': [{'name': 'Dietary Fiber', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Fiber'], 'description': 'Given fiber supplement', 'armGroupLabels': ['Cross-over Randomization 1: Fiber plus Fish Oil followed by Comparator', 'Cross-over Randomization 2: Comparator followed by Fiber plus Fish Oil']}, {'name': 'Fish Oil', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Oil, Fish', 'Seafood Oil'], 'description': 'Given fish oil supplement', 'armGroupLabels': ['Cross-over Randomization 1: Fiber plus Fish Oil followed by Comparator', 'Cross-over Randomization 2: Comparator followed by Fiber plus Fish Oil']}, {'name': 'Comparator', 'type': 'OTHER', 'otherNames': ['placebo therapy', 'PLCB', 'sham therapy'], 'description': 'Given fiber supplement placebo', 'armGroupLabels': ['Cross-over Randomization 1: Fiber plus Fish Oil followed by Comparator', 'Cross-over Randomization 2: Comparator followed by Fiber plus Fish Oil']}, {'name': 'Comparator', 'type': 'OTHER', 'otherNames': ['placebo therapy', 'PLCB', 'sham therapy'], 'description': 'Given fish oil supplement placebo (corn oil)', 'armGroupLabels': ['Cross-over Randomization 1: Fiber plus Fish Oil followed by Comparator', 'Cross-over Randomization 2: Comparator followed by Fiber plus Fish Oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutch/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Johanna Lampe', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Texas A&M University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Johanna Lampe', 'investigatorAffiliation': 'Fred Hutchinson Cancer Center'}}}}