Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-03-01 @ 10:02 AM
Study NCT ID:
NCT01803633
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2013-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determine How Consumption of Dairy Fat as Cheese Influences Inflammation-Phase 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-01-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2013-02-28', 'studyFirstSubmitQcDate': '2013-03-01', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma inflammatory mediators', 'timeFrame': '0, 1, 3, 6 hr postprandial', 'description': 'Plasma cytokines will be measured using a multi-plex immunoassay and plasma oxylipins will be measured by mass spectroscopy.'}], 'secondaryOutcomes': [{'measure': 'Plasma lipid profile', 'timeFrame': '0, 1, 3, 6 hours postprandial', 'description': 'Plasma lipids (triglycerides, total cholesterol, LDL-C, HDL-C) will be measured by enzymatic analysis by UC Davis Pathology Lab.'}, {'measure': 'Plasma bone markers', 'timeFrame': '0, 1, 3, 6 hours postprandial', 'description': 'Plasma N-terminal telopeptide (NTX), C-terminal telopeptide (CTX) and propeptide of type I collagen (P1NP) will be measured by multi-plex immunoassay.'}, {'measure': 'Urinary metabolites', 'timeFrame': '0, 1, 3, 6 hours postprandial', 'description': 'Urinary metabolites will be measured by nuclear magnetic resonance (NMR) spectroscopy.'}, {'measure': 'Plasma glucose', 'timeFrame': '0, 1, 3, 6 hours postprandial', 'description': 'Plasma glucose will be measured by enzymatic analysis by UC Davis Pathology Lab.'}, {'measure': 'Plasma lipoprotein size distribution', 'timeFrame': '0, 1, 3, 6 hours postprandial', 'description': 'Plasma lipoprotein size distribution and lipoprotein concentrations will be measured by LipoScience using NMR spectroscopy.'}, {'measure': 'Red blood cell functionality', 'timeFrame': '0, 1, 3, 6 hours postprandial', 'description': 'Red blood cells isolated from whole blood will be measured for sheer stress using an in-vitro microfluidic assay.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '21270379', 'type': 'BACKGROUND', 'citation': 'Astrup A, Dyerberg J, Elwood P, Hermansen K, Hu FB, Jakobsen MU, Kok FJ, Krauss RM, Lecerf JM, LeGrand P, Nestel P, Riserus U, Sanders T, Sinclair A, Stender S, Tholstrup T, Willett WC. The role of reducing intakes of saturated fat in the prevention of cardiovascular disease: where does the evidence stand in 2010? Am J Clin Nutr. 2011 Apr;93(4):684-8. doi: 10.3945/ajcn.110.004622. Epub 2011 Jan 26.'}, {'pmid': '22810464', 'type': 'BACKGROUND', 'citation': 'Kratz M, Baars T, Guyenet S. The relationship between high-fat dairy consumption and obesity, cardiovascular, and metabolic disease. Eur J Nutr. 2013 Feb;52(1):1-24. doi: 10.1007/s00394-012-0418-1. Epub 2012 Jul 19.'}, {'pmid': '21896876', 'type': 'BACKGROUND', 'citation': 'Hostmark AT, Tomten SE. The Oslo health study: cheese intake was negatively associated with the metabolic syndrome. J Am Coll Nutr. 2011 Jun;30(3):182-90. doi: 10.1080/07315724.2011.10719959.'}, {'pmid': '15533268', 'type': 'BACKGROUND', 'citation': 'Biong AS, Muller H, Seljeflot I, Veierod MB, Pedersen JI. A comparison of the effects of cheese and butter on serum lipids, haemostatic variables and homocysteine. Br J Nutr. 2004 Nov;92(5):791-7. doi: 10.1079/bjn20041257.'}, {'pmid': '15047684', 'type': 'BACKGROUND', 'citation': 'Tholstrup T, Hoy CE, Andersen LN, Christensen RD, Sandstrom B. Does fat in milk, butter and cheese affect blood lipids and cholesterol differently? J Am Coll Nutr. 2004 Apr;23(2):169-76. doi: 10.1080/07315724.2004.10719358.'}, {'pmid': '27313852', 'type': 'RESULT', 'citation': 'Demmer E, Van Loan MD, Rivera N, Rogers TS, Gertz ER, German JB, Zivkovic AM, Smilowitz JT. Consumption of a high-fat meal containing cheese compared with a vegan alternative lowers postprandial C-reactive protein in overweight and obese individuals with metabolic abnormalities: a randomised controlled cross-over study. J Nutr Sci. 2016 Feb 9;5:e9. doi: 10.1017/jns.2015.40. eCollection 2016.'}, {'pmid': '27258098', 'type': 'RESULT', 'citation': 'Zeng NF, Mancuso JE, Zivkovic AM, Smilowitz JT, Ristenpart WD. Red Blood Cells from Individuals with Abdominal Obesity or Metabolic Abnormalities Exhibit Less Deformability upon Entering a Constriction. PLoS One. 2016 Jun 3;11(6):e0156070. doi: 10.1371/journal.pone.0156070. eCollection 2016.'}], 'seeAlsoLinks': [{'url': 'http://ffhi.ucdavis.edu/human-studies/dairy-fat-inflammation', 'label': 'Link to the UC Davis Foods for Health Institute where more information about this research project is available.'}]}, 'descriptionModule': {'briefSummary': 'Phase 2 of this study involves determining how consumption of cheese compared with a non-dairy cheese substitute influences inflammation over a six hour period.', 'detailedDescription': "Phase 2 is a randomized crossover study designed to determine how consumption of cheese compared with a non-dairy cheese substitute influences postprandial inflammation in participants who have 2 or more risk factors of metabolic syndrome or BMI ≥ 30.\n\nEligible participants will arrive to the Western Human Nutrition Research Center (WHNRC) at the University of California (UC) Davis campus on the morning of each test day after a 10-12-hr overnight fast. Upon arrival participants will fill out a questionnaire about their dietary and medication intakes and physical activity for the past 72 hours to ensure compliance. Compliant participants' weight and blood pressure will be measured and a fasting blood draw will be taken before participants consume their test meal (cheese or non-dairy cheese substitute). Participants will only consume this test meal and water freely for the duration of the test day. Blood will be drawn serially at 1, 3 and 6 hours postprandially. Participants will be tested on a second test day two weeks after the first test.\n\nOn the second test day, participants' body composition and bone mineral density will be measured by dual x-ray absorptiometry."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-65 years\n* Two or more components of metabolic syndrome:\n\nCentral obesity (waist circumference greater than 40 inches for men and 35 inches for women); fasting blood triglycerides greater than or equal to 150 mg/dL; plasma HDL cholesterol (Less than 40 mg/dL for men and less than 50 mg/dL for women); blood pressure greater than or equal to 130/85 mmHg; fasting glucose greater than or equal to 100 mg/dL\n\nor\n\n\\- BMI equal to or greater than 30\n\nExclusion Criteria:\n\nMetabolic Disorders:\n\n* BMI \\> 40\n* Body weight more than 400 lbs.\n* Any immune related diseases such as autoimmune disease, rheumatoid arthritis, asthma,\n* Gastrointestinal disorders including Crohn's Disease, colitis, diverticulitis, irritable bowel disease, celiac, malabsorption syndrome\n* Cancer\n* Known presence of significant metabolic disease which could impact the results of the study (i.e. hepatic, renal disease)\n* Type II diabetes\n* Use of over-the-counter anti-obesity agents (e.g. containing phenylpropanolamine, ephedrine, and/or caffeine) within the last 12 weeks\n* Use of corticoid steroids within the last 12 weeks\n* Daily use of anti-inflammatory pain medication\n* Self report of eating disorder\n* Poor vein assessment determined by WHNRC's phlebotomist\n\nDietary/supplements:\n\n* Known allergy or intolerance to study food (lactose intolerance, dairy, wheat allergies)\n* Vegetarian (defined as abstinence from consumption of eggs, dairy, poultry, beef and pork)\n* More than 1 serving of fish per week\n* More than 14 grams of fiber per 1000 kcal per day\n* Less than 16:1 of total dietary omega 6: Omega 3 ratio\n* More than 1% of daily energy as trans fats\n* Initiation of anti-inflammatory supplemental fish, krill, flax, borage and primrose seed oils within the last 12 weeks\n* Dietary supplements consisting of concentrated soy isoflavones, resveratrol, other polyphenols identified as modulators of inflammation Medications\n* Initiation of statin therapy within the last 12 weeks Lifestyle\n* More than 10% weight loss or gain during the past 6 months\n* Recent initiation (past 4 weeks) of exercise program\n* Plan to become pregnant in the next 6 months\n* Pregnancy or lactation\n* Recent initiation or cessation of hormonal birth control or change in hormonal birth control regimen within the last 12 weeks\n* Use of tobacco products\n* More than 2 standard alcoholic drinks per day."}, 'identificationModule': {'nctId': 'NCT01803633', 'briefTitle': 'Determine How Consumption of Dairy Fat as Cheese Influences Inflammation-Phase 2', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Effects of Dairy Fat on Postprandial Inflammation- Phase 2', 'orgStudyIdInfo': {'id': '264297'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cheese', 'description': "Cheese sandwich plus supplemental beverage will deliver 40% of each participants' energy expenditure and will be made up of 50% of energy as fat, 35% of energy as carbohydrate and 15% of energy as protein. The sandwich will contain medium cheddar cheese and whole wheat bread. The supplemental beverage will contain fruit sorbet, glucose polymer, protein powder, high oleic sunflower oil, high polyunsaturated fatty acids (PUFA) sunflower oil, and canola oil.", 'interventionNames': ['Other: Cheddar cheese']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vegan cheese', 'description': "Non-dairy cheese alternative sandwich plus supplemental beverage will deliver 40% of each participants' energy expenditure and will be made up of 50% of energy as fat, 35% of energy as carbohydrate and 15% of energy as protein. The sandwich will contain vegan cheese and whole wheat bread. The supplemental beverage will contain fruit sorbet, glucose polymer, protein powder, cream of tartar, high oleic sunflower oil, high PUFA sunflower oil, and palm oil.", 'interventionNames': ['Other: Vegan cheese']}], 'interventions': [{'name': 'Cheddar cheese', 'type': 'OTHER', 'description': 'Tillamook medium cheddar cheese brand', 'armGroupLabels': ['Cheese']}, {'name': 'Vegan cheese', 'type': 'OTHER', 'description': 'Daiya brand vegan cheese', 'armGroupLabels': ['Vegan cheese']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'USDA Western Human Nutrition Research Center', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}], 'overallOfficials': [{'name': 'Jennifer T. Smilowitz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}, {'name': 'Angela M. Zivkovic, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}, {'name': 'Marta Van Loan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ARS USDA WHNRC'}, {'name': 'J. Bruce German, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Davis'}, {'name': 'Bruce D. Hammock, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dairy Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}