Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT01803594
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2013-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feeding Trial to Determine How Combinations of Different Dietary Bioactive Ingredients Influence High Density Lipoprotein (HDL) Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014975', 'term': 'Lutein'}, {'id': 'D009525', 'term': 'Niacin'}], 'ancestors': [{'id': 'D024341', 'term': 'Xanthophylls'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2015-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2013-02-28', 'studyFirstSubmitQcDate': '2013-03-01', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma lipoprotein profile', 'timeFrame': '0, 2, 4 hour postprandial', 'description': 'Plasma lipoprotein size distribution and concentration will be measured by nuclear magnetic resonance (NMR)'}], 'secondaryOutcomes': [{'measure': 'Plasma HDL proteome', 'timeFrame': '0, 2, 4 hours postprandial', 'description': 'HDL particles isolated by ultracentrifugation will be characterized for their proteomics profile measured by mass spectrometry.'}, {'measure': 'Urinary metabolomics', 'timeFrame': '0, 2, 4 hours', 'description': 'Urinary metabolites will be measured by NMR spectroscopy.'}, {'measure': 'Red blood cell functionality', 'timeFrame': '0, 2, 4 hours postprandially', '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': ['Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '19713204', 'type': 'BACKGROUND', 'citation': 'Dalbeth N, Gracey E, Pool B, Callon K, McQueen FM, Cornish J, MacGibbon A, Palmano K. Identification of dairy fractions with anti-inflammatory properties in models of acute gout. Ann Rheum Dis. 2010 Apr;69(4):766-9. doi: 10.1136/ard.2009.113290. Epub 2009 Aug 26.'}, {'pmid': '21524510', 'type': 'BACKGROUND', 'citation': 'Snow DR, Ward RE, Olsen A, Jimenez-Flores R, Hintze KJ. Membrane-rich milk fat diet provides protection against gastrointestinal leakiness in mice treated with lipopolysaccharide. J Dairy Sci. 2011 May;94(5):2201-12. doi: 10.3168/jds.2010-3886.'}, {'pmid': '15531663', 'type': 'BACKGROUND', 'citation': 'Mozaffarian D, Rimm EB, Herrington DM. Dietary fats, carbohydrate, and progression of coronary atherosclerosis in postmenopausal women. Am J Clin Nutr. 2004 Nov;80(5):1175-84. doi: 10.1093/ajcn/80.5.1175.'}, {'pmid': '12792657', 'type': 'BACKGROUND', 'citation': 'Tholstrup T, Vessby B, Sandstrom B. Difference in effect of myristic and stearic acid on plasma HDL cholesterol within 24 h in young men. Eur J Clin Nutr. 2003 Jun;57(6):735-42. doi: 10.1038/sj.ejcn.1601605.'}, {'pmid': '15656713', 'type': 'BACKGROUND', 'citation': 'Bunea R, El Farrah K, Deutsch L. Evaluation of the effects of Neptune Krill Oil on the clinical course of hyperlipidemia. Altern Med Rev. 2004 Dec;9(4):420-8.'}, {'pmid': '15640510', 'type': 'BACKGROUND', 'citation': 'Ribaya-Mercado JD, Blumberg JB. Lutein and zeaxanthin and their potential roles in disease prevention. J Am Coll Nutr. 2004 Dec;23(6 Suppl):567S-587S. doi: 10.1080/07315724.2004.10719427.'}, {'pmid': '12947433', 'type': 'BACKGROUND', 'citation': 'Kiokias S, Gordon MH. Dietary supplementation with a natural carotenoid mixture decreases oxidative stress. Eur J Clin Nutr. 2003 Sep;57(9):1135-40. doi: 10.1038/sj.ejcn.1601655.'}], 'seeAlsoLinks': [{'url': 'http://ffhi.ucdavis.edu/human-studies/hdl-metabolic-milkshake', 'label': "More information about the research is available on the UC Davis Foods for Health Institute's website"}]}, 'descriptionModule': {'briefSummary': "This study involves measuring subject's blood lipid responses after they consume a mixture of dietary fats of marine and dairy origin and vitamin supplements mixed into a milkshake, on three separate days. The investigators hope to learn more about how different food ingredients influence the metabolism HDL in individuals with low blood levels of HDL cholesterol.", 'detailedDescription': "This study a partial randomized crossover study designed to determine how consumption of bioactive dietary ingredients in various combinations on three separate test days influences postprandial lipoprotein metabolism in participants with low circulating HDL-cholesterol.\n\nThe dietary ingredients include:\n\nDairy phospholipids(PC700); krill oil (K); lutein (L); and Niacin\n\nEligible participants will arrive to the University of California Davis (UC Davis), Ragle Human Nutrition Center 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 in the form of a milkshake (control, PC700KL, PC700KL + Niacin). On each test day, participants will be given only this meal and provided with ample supply of bottled water.\n\nParticipants will only consume this test meal and water freely for the duration of the test day. Blood will be drawn serially at 2 and 4 hours postprandially. Participants will also be asked to provide 3 urine samples throughout the study: before and 2, and 4 hours after consumption of the milkshake. Participants will be tested on two additional separate test days after the first day separated by a two-week washout. The first two test days will be randomized, however the third test day will always contain niacin in order to require participants remain at Ragle for the first two hours of the study to monitor niacin flushing reactions. Participants have the option of participating in two out of three of the test days if they wish to exclude themselves from the niacin test day."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years\n* Plasma HDL cholesterol (Less than 50 mg/dL)\n\nExclusion Criteria:\n\n* History of gastrointestinal disorders like Crohns disease, colitis, irritable bowel syndrome\n* History of cardiovascular events: stroke, heart attack, cardiac arrhythmia\n* History of peptic ulcers, gastritis\n* History of gout\n* History of being under care of any psychiatric conditions (schizophrenia and depression associated with response to niacin)\n* Cancer\n* Type 1 or 2 diabetes\n* Known presence of significant metabolic disease which could impact results of study (hepatic, renal disease)\n* Low blood pressure (defined as 3 consecutive readings below 100/60 mmHg at screening)\n* Self report skin sensitivities; self report to rash easily\n* Self report to hot flashes currently experience due to menopause\n* Hypersensitivity to niacin\n* Muscle disorders such as myasthenia gravis\n* Pending surgery within the next 3 months\n* Known allergy to study food (shellfish, fish, nut, soy)\n* Known intolerance to study food (lactose intolerance)\n* More than 1 serving of fish per week\n* Intake of anti-inflammatory supplemental fish, krill, borage, flax, and primrose seed oils within the last 12 weeks\n* Intake of dietary supplements consisting of concentrated soy isoflavones, resveratrol, other dietary polyphenols identified as modulators of lipids within the last 12 weeks\n* Intake of more than 20 mg of lutein and zeaxanthin per week\n* Intake of nicotinic acid (niacin) within the last 12 weeks\n* Intake of anti-coagulants, blood pressure or heart medications within the last 12 weeks\n* Plan to become pregnant in next 6 months\n* Recent initiation (past 4 weeks) of exercise program\n* Use of tobacco products\n* Excessive alcohol consumption (2 drinks/day for men and 1 drink/day for women)'}, 'identificationModule': {'nctId': 'NCT01803594', 'acronym': 'HDL', 'briefTitle': 'Feeding Trial to Determine How Combinations of Different Dietary Bioactive Ingredients Influence High Density Lipoprotein (HDL) Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Postprandial Modulation of HDL Metabolism', 'orgStudyIdInfo': {'id': '264254'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Shake', 'description': "Each shake delivers 30% of each participant's calculated energy expenditure and provides 45% energy as fat, 40% energy as carbohydrate and 15% energy as protein. The shake contains whipping cream, frozen fruit, glucose polymer, and protein powder.", 'interventionNames': ['Other: Control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PC700, Krill Oil, and Lutein', 'description': "Each shake delivers 30% of each participant's calculated energy expenditure and provides 45% energy as fat, 40% energy as carbohydrate and 15% energy as protein. The shake contains whipping cream, frozen fruit, glucose polymer, and protein powder. Fifty percent of the fat is made up of PC700. Additionally, 3.0g Krill oil and 40mg of lutein capsules are swallowed with water.\n\nNeptune Krill Oil capsules (Nutrigold); Lutein capsules (Jarrow Formulas); PC700 = dairy lipids (Fonterra brand)", 'interventionNames': ['Dietary Supplement: Krill Oil', 'Dietary Supplement: Lutein', 'Dietary Supplement: Dairy phospholipids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PC700, Krill Oil, Lutein, and Niacin', 'description': "Each shake delivers 30% of each participant's calculated energy expenditure and provides 45% energy as fat, 40% energy as carbohydrate and 15% energy as protein. The shake contains whipping cream, frozen fruit, glucose polymer, and protein powder. Fifty percent of the fat is made up of PC700. Additionally, 3.0g Krill oil and 40mg of lutein capsules are swallowed with water. Nicotinic acid was added to each shake prior to consumption at a doses 5mg/kg of body weight.\n\nNeptune Krill Oil capsules (Nutrigold); Lutein capsules (Jarrow Formulas); PC700 (Fonterra); Nicotinic acid (Natures Way)", 'interventionNames': ['Dietary Supplement: Krill Oil', 'Dietary Supplement: Lutein', 'Dietary Supplement: Nicotinic acid', 'Dietary Supplement: Dairy phospholipids']}], 'interventions': [{'name': 'Krill Oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Neptune Krill Oil Gold', 'armGroupLabels': ['PC700, Krill Oil, Lutein, and Niacin', 'PC700, Krill Oil, and Lutein']}, {'name': 'Lutein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Jarrow Formulas', 'armGroupLabels': ['PC700, Krill Oil, Lutein, and Niacin', 'PC700, Krill Oil, and Lutein']}, {'name': 'Nicotinic acid', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Natures Way', 'armGroupLabels': ['PC700, Krill Oil, Lutein, and Niacin']}, {'name': 'Dairy phospholipids', 'type': 'DIETARY_SUPPLEMENT', 'description': 'PC700 manufactured by Fonterra', 'armGroupLabels': ['PC700, Krill Oil, Lutein, and Niacin', 'PC700, Krill Oil, and Lutein']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Control shake without dietary supplements', 'armGroupLabels': ['Control Shake']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis, Ragle Human Nutrition Center', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}], 'overallOfficials': [{'name': 'Jennifer T Smilowitz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}, {'name': 'J. Bruce German, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Unilever R&D', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}