Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-21 @ 6:51 AM
Study NCT ID:
NCT00866450
Status:
COMPLETED
Last Update Posted:
2012-01-11
First Post:
2009-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Western-type Diet on Colorectal Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002118', 'term': 'Calcium'}, {'id': 'D018752', 'term': 'Diet, Fat-Restricted'}], 'ancestors': [{'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-10', 'studyFirstSubmitDate': '2009-03-19', 'studyFirstSubmitQcDate': '2009-03-19', 'lastUpdatePostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammation in the rectosigmoid epithelium', 'timeFrame': 'visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention'}], 'secondaryOutcomes': [{'measure': 'Circulating endotoxin levels', 'timeFrame': 'visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention'}, {'measure': 'Expression profiles of pro- and anti-inflammatory genes in rectosigmoid biopsies', 'timeFrame': 'visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention'}, {'measure': 'Gut permeability', 'timeFrame': 'visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention'}, {'measure': 'Inflammatory cytokines in the colorectal mucosa and serum', 'timeFrame': 'visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention'}, {'measure': 'Luminal and adherent gut microbiota', 'timeFrame': 'visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention'}, {'measure': 'Fecal calprotectin levels in the stool samples', 'timeFrame': 'visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colorectal Inflammation']}, 'descriptionModule': {'briefSummary': "This study will look at the inflammatory (changes usually associated with infection/injury to the body) and bowel permeability (bowel's ability to allow contents to enter the body) effects of a Western-style diet (high fat and low in calcium) and a prudent-style diet (low fat and high in calcium) on the colon (large bowel). This study may provide information to prevent colorectal cancer in a high-risk population", 'detailedDescription': 'Hypothesis: Compared to a prudent-style diet, does a western-style diet increase colorectal inflammation thereby increasing gut permeability and causing increased endotoxins and markers of systemic inflammation.\n\nThis is a single blind crossover study. Subjects will be randomized to begin on either a WD or a PD for 30 + 3 days. Once that dietary intervention is complete, subjects will have a four (4) week wash-out period and then will be placed on the other dietary intervention for 30 + 3 days. The following study measures are performed during both the dietary intervention study periods. All the baseline tests will be repeated at the end of each dietary intervention period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '72 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or post-menopausal ( 2 years after menopause or stopping HRT)healthy female subjects\n* Age between 50 and 72 years\n* At increased risk for colorectal cancer (this includes those have had a colorectal adenoma excised, or have a first or second degree relative with colorectal neoplasia).\n\nExclusion Criteria:\n\n* Personal history of cancer other than non-melanoma skin cancer within the past 10 years\n* History of hereditary non-polyposis colon cancer\n* Intestinal malabsorption, inflammatory bowel disease\n* Prior gastrointestinal surgery other than appendectomy or surgery of the esophagus\n* Any excess bleeding or coagulation disorders\n* Subjects taking anti-coagulants, sterol-binding resins, NSAIDs other than aspirin, \\< 600mg per day, other study medications, or other multiple medications that might, in the view of the study physicians, alter colonic function or inflammation\n* Total cholesterol greater than 240mg/dl, triglycerides \\> 600mg, LDL-C \\> 175\n* Subjects with a history of coronary artery disease\n* HIV positive subjects\n* Subjects taking antibiotics, anti-diabetes, hormone replacement therapy, oral, transplanted or injected contraceptives (thyroid hormone therapy is permitted as long as the subject is euthyroid)\n* Currently participating in other clinical studies or completed participation in other clinical studies within the last 30 days'}, 'identificationModule': {'nctId': 'NCT00866450', 'briefTitle': 'Effects of a Western-type Diet on Colorectal Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Rockefeller University'}, 'officialTitle': 'Effects of a Western-type Diet on Colorectal Inflammation, Gut Permeability and Systemic Endotoxemia', 'orgStudyIdInfo': {'id': 'SWP-0658'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Western style diet', 'description': 'high-fat, low-calcium diet', 'interventionNames': ['Dietary Supplement: Western style diet (high fat and low in calcium)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prudent diet', 'description': 'low-fat, calcium-sufficient diet', 'interventionNames': ['Dietary Supplement: Prudent-style diet (low fat and high in calcium)']}], 'interventions': [{'name': 'Western style diet (high fat and low in calcium)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects will be randomized to begin on either a WD or a PD for 30 + 3 days. Once that dietary intervention is complete, subjects will have a four (4) week wash-out period and then will be placed on the other dietary intervention for 30 + 3 days', 'armGroupLabels': ['Western style diet']}, {'name': 'Prudent-style diet (low fat and high in calcium)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects will be randomized to begin on either a WD or a PD for 30 + 3 days. Once that dietary intervention is complete, subjects will have a four (4) week wash-out period and then will be placed on the other dietary intervention for 30 + 3 days', 'armGroupLabels': ['Prudent diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Rockefeller University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Swaroop Pendyala, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rockefeller University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rockefeller University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}