Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-15 @ 10:09 AM
Study NCT ID:
NCT01686204
Status:
COMPLETED
Last Update Posted:
2017-10-03
First Post:
2012-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-29', 'studyFirstSubmitDate': '2012-09-12', 'studyFirstSubmitQcDate': '2012-09-12', 'lastUpdatePostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fasting lipopolysaccharide binding protein (LBP)', 'timeFrame': '0 and 9 wk', 'description': 'Determined by immunoassay'}, {'measure': 'Fasting plasma endotoxin (LPS, lipopolysaccharide)', 'timeFrame': '0, 9 wk', 'description': 'Determined by limulus amebocyte lysate assay'}, {'measure': 'Fasting plasma core antibodies to endotoxin', 'timeFrame': '0 and 9 wk', 'description': 'Immunoglobulin M Endotoxin-core antibody (IgM EndoCAb)'}, {'measure': 'Fasting plasma anandamide (AEA)', 'timeFrame': '0, 9 wk', 'description': 'Determined by LC-MS'}, {'measure': 'Fasting plasma 2-arachidonoylglycerol (2-AG)', 'timeFrame': '0, 9 wk', 'description': 'Determined by LC-MS'}, {'measure': 'Fasting plasma IL-10', 'timeFrame': '0, 9 wk', 'description': 'Determined by immunoassay'}, {'measure': 'Fasting plasma high-sensitivity C-reactive protein (hsCRP)', 'timeFrame': '0, 9 wk', 'description': 'Determined in fasting plasma'}, {'measure': 'Fasting plasma Tumor Necrosis Factor-alpha (TNF-α)', 'timeFrame': '0, 9 wk', 'description': 'Determined in fasting plasma'}, {'measure': 'Fasting plasma Soluble TNF-Receptor II (sTNF-RII)', 'timeFrame': '0, 9 wk', 'description': 'Determined in fasting plasma'}, {'measure': 'TNF-alpha/sTNF-RII ratio', 'timeFrame': '0, 9 wk', 'description': 'Determined in fasting plasma'}, {'measure': 'Fasting plasma glucose', 'timeFrame': '0, 9 wk', 'description': 'Determined in fasting plasma'}, {'measure': 'Fasting plasma triglycerides', 'timeFrame': '0, 9 wk', 'description': 'Determined in fasting plasma'}, {'measure': 'Fasting plasma insulin', 'timeFrame': '0, 9 wk', 'description': 'Determined in fasting plasma'}, {'measure': 'Fasting plasma soluble cluster of differentiation 14 (sCD14)', 'timeFrame': '0, 9 wk', 'description': 'Determined in fasting plasma'}, {'measure': 'Body weight', 'timeFrame': '0, 3, 6, 9 wk'}, {'measure': 'Body mass index', 'timeFrame': '0, 3, 6, 9 wk'}, {'measure': 'Waist circumference', 'timeFrame': '0, 3, 6, 9 wk'}, {'measure': 'Systolic blood pressure', 'timeFrame': '0, 3, 6, 9 wk'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '0, 3, 6, 9 wk'}, {'measure': 'Fasting RPLP0, encoding ribosomal protein large P0', 'timeFrame': '0, 9 wk', 'description': 'mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)'}, {'measure': 'TLR4, encoding Toll-like receptor 4', 'timeFrame': '0, 9 wk', 'description': 'mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)'}, {'measure': 'RELA, encoding p65 subunit of nuclear factor kappa B', 'timeFrame': '0, 9 wk', 'description': 'mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)'}, {'measure': 'NFKBIA, encoding nuclear factor kappa B inhibitor alpha', 'timeFrame': '0, 9 wk', 'description': 'mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)'}, {'measure': 'PTGS2, encoding cyclooxygenase-2 (COX-2)', 'timeFrame': '0, 9 wk', 'description': 'mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)'}, {'measure': 'NCF1,encoding the p47 subunit of nicotinamide adenine dinucleotide phosphate-oxidase, (NADPH oxidase)', 'timeFrame': '0, 9 wk', 'description': 'mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)'}, {'measure': 'TNF, encoding tumor necrosis factors (TNF)', 'timeFrame': '0, 9 wk', 'description': 'mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)'}, {'measure': 'IFNG, encoding interferon-γ', 'timeFrame': '0, 9 wk', 'description': 'mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)'}, {'measure': 'TGFB1, encoding transforming growth factor beta 1 (TGFβ1)', 'timeFrame': '0, 9 wk', 'description': 'mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)'}, {'measure': 'Postprandial plasma glucose', 'timeFrame': '0, 9 wk', 'description': 'Postprandial plasma glucose following a high-fat, high-calorie challenge meal (area under curve)'}, {'measure': 'Postprandial plasma triglycerides', 'timeFrame': '0, 9 wk', 'description': 'Postprandial plasma triglycerides following a high-fat, high-calorie challenge meal (area under curve)'}, {'measure': 'Postprandial lipopolysaccharide binding protein (LBP)', 'timeFrame': '0, 9 wk', 'description': 'Postprandial plasma LBP following a high-fat, high-calorie challenge meal (area under curve)'}, {'measure': 'Postprandial lipopolysaccharide (LPS)', 'timeFrame': '0, 9 wk', 'description': 'Postprandial plasma LPS following a high-fat, high-calorie challenge meal determined by limulus amebocyte lysate assay (area under curve)'}, {'measure': 'Postprandial lipopolysaccharide binding protein (LBP)/soluble cluster of differentiation 14 (sCD14) ratio', 'timeFrame': '0, 9 wk', 'description': 'Postprandial LBP/sCD14 ratio following a high-fat, high-calorie challenge meal (area under curve)'}, {'measure': 'Postprandial plasma insulin', 'timeFrame': '0, 9 wk', 'description': 'Postprandial plasma insulin following a high-fat, high-calorie challenge meal (area under curve)'}, {'measure': 'Energy intake (kcal)', 'timeFrame': '0, 9 wk', 'description': 'Self-reported food intake determined by dietary records'}, {'measure': 'Total fat (g)', 'timeFrame': '0, 9 wk', 'description': 'Self-reported nutrient intake determined by dietary records'}, {'measure': 'Carbohydrate (g)', 'timeFrame': '0, 9 wk', 'description': 'Self-reported nutrient intake determined by dietary records'}, {'measure': 'Total protein (g)', 'timeFrame': '0, 9 wk', 'description': 'Self-reported nutrient intake determined by dietary records'}, {'measure': 'Total fat (%)', 'timeFrame': '0, 9 wk', 'description': 'Self-reported nutrient intake determined by dietary records'}, {'measure': 'Carbohydrate (%)', 'timeFrame': '0, 9 wk', 'description': 'Self-reported nutrient intake determined by dietary records'}, {'measure': 'Total protein (%)', 'timeFrame': '0, 9 wk', 'description': 'Self-reported nutrient intake determined by dietary records'}, {'measure': 'Cholestrol (mg)', 'timeFrame': '0, 9 wk', 'description': 'Self-reported nutrient intake determined by dietary records'}, {'measure': 'Saturated fatty acids (g)', 'timeFrame': '0, 9 wk', 'description': 'Self-reported nutrient intake determined by dietary records'}, {'measure': 'Vitamin D (μg)', 'timeFrame': '0, 9 wk', 'description': 'Self-reported nutrient intake determined by dietary records'}, {'measure': 'Calcium (mg)', 'timeFrame': '0, 9 wk', 'description': 'Self-reported nutrient intake determined by dietary records'}, {'measure': 'Sodium (mg)', 'timeFrame': '0, 9 wk', 'description': 'Self-reported nutrient intake determined by dietary records'}, {'measure': 'Potassium (mg)', 'timeFrame': '0, 9 wk', 'description': 'Self-reported nutrient intake determined by dietary records'}, {'measure': 'Total sugars (g)', 'timeFrame': '0, 9 wk', 'description': 'Self-reported nutrient intake determined by dietary records'}, {'measure': 'Added sugars (g)', 'timeFrame': '0, 9 wk', 'description': 'Self-reported nutrient intake determined by dietary records'}], 'primaryOutcomes': [{'measure': 'Plasma soluble cluster of differentiation 14 (sCD14)', 'timeFrame': '0, 3, 6, and 9 wk', 'description': 'Fasting plasma sCD14 (change from baseline)'}], 'secondaryOutcomes': [{'measure': 'Fasting plasma interleukin-6 (IL-6)', 'timeFrame': '0, 3, 6, 9 wk', 'description': 'Fasting plasma IL-6 (change from baseline)'}, {'measure': 'Postprandial sCD14', 'timeFrame': '0 and 9 wk', 'description': 'Postprandial plasma sCD14 following a high-fat, high-calorie challenge meal (area under curve)'}, {'measure': 'Postprandial interleukin-6 (IL-6)', 'timeFrame': '0 and 9 wk', 'description': 'Postprandial plasma IL-6 following a high-fat, high-calorie challenge meal (area under curve)'}]}, 'conditionsModule': {'keywords': ['Yogurt', 'Intestine', 'Inflammation', 'Obese'], 'conditions': ['Intestinal Barrier Function', 'Chronic Inflammation']}, 'referencesModule': {'references': [{'pmid': '29767743', 'type': 'DERIVED', 'citation': 'Pei R, DiMarco DM, Putt KK, Martin DA, Chitchumroonchokchai C, Bruno RS, Bolling BW. Premeal Low-Fat Yogurt Consumption Reduces Postprandial Inflammation and Markers of Endotoxin Exposure in Healthy Premenopausal Women in a Randomized Controlled Trial. J Nutr. 2018 Jun 1;148(6):910-916. doi: 10.1093/jn/nxy046.'}, {'pmid': '29179781', 'type': 'DERIVED', 'citation': 'Pei R, DiMarco DM, Putt KK, Martin DA, Gu Q, Chitchumroonchokchai C, White HM, Scarlett CO, Bruno RS, Bolling BW. Low-fat yogurt consumption reduces biomarkers of chronic inflammation and inhibits markers of endotoxin exposure in healthy premenopausal women: a randomised controlled trial. Br J Nutr. 2017 Dec;118(12):1043-1051. doi: 10.1017/S0007114517003038. Epub 2017 Nov 28.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this work is to conduct a clinical trial in obese and non-obese individuals testing the ability of low-fat dairy yogurt to improve gastrointestinal health and reduce chronic inflammation. Our central hypothesis is that short and long-term consumption of low-fat dairy yogurt will reduce inflammation to a greater extent in obese individuals by improving intestinal barrier function.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* premenopausal women\n* BMI from 18.5-27 and 30-40 kg/m2\n* resting blood pressure \\<140/90 mmHg\n* not taking medication to control hypertension\n* stable body weight for the previous 2 months\n* willing to maintain a normal exercise level and avoid exercise 24 h prior to blood sampling\n* willing to avoid yogurt and probiotic-containing foods or consume 2 servings of yogurt for the duration of the study\n\nExclusion Criteria:\n\n* previous diagnoses of cardiovascular disease (CVD), diabetes, or arthritis (except for osteo-arthritis)\n* currently being treated for cancer (i.e., chemotherapy, radiation therapy)\n* prescribed estrogen replacement therapy\n* practicing weight-loss, vegetarian, kosher, or vegan diets\n* currently taking dietary supplements\n* exceed alcohol consumption more than moderate drinking (1 drink/day or a total of 7/week)\n* actively using antibiotics\n* taking anti-inflammatory drugs\n* have allergies to soy, egg or milk\n* perimenopausal or menopausal symptoms'}, 'identificationModule': {'nctId': 'NCT01686204', 'briefTitle': 'Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt', 'orgStudyIdInfo': {'id': '2014-0669'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non-obese individuals', 'description': 'Daily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks.', 'interventionNames': ['Other: Low fat dairy yogurt', 'Other: Soy pudding']}, {'type': 'EXPERIMENTAL', 'label': 'Obese individuals', 'description': 'Consumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks.', 'interventionNames': ['Other: Low fat dairy yogurt', 'Other: Soy pudding']}], 'interventions': [{'name': 'Low fat dairy yogurt', 'type': 'OTHER', 'description': 'Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks', 'armGroupLabels': ['Non-obese individuals', 'Obese individuals']}, {'name': 'Soy pudding', 'type': 'OTHER', 'description': 'Consumption of 12 oz of low fat soy pudding daily for 9 weeks.', 'armGroupLabels': ['Non-obese individuals', 'Obese individuals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53706', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Department of Food Science, Babcock Hall', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Bradley W Bolling, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dairy Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}