Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-25 @ 12:33 AM
Study NCT ID:
NCT02061267
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2014-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olive Oil and Nampt on Postprandial Inflammation and Atherosclerosis in the Setting of Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009525', 'term': 'Niacin'}, {'id': 'D002079', 'term': 'Butter'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D000069463', 'term': 'Olive Oil'}, {'id': 'D019301', 'term': 'Oleic Acid'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D004281', 'term': 'Docosahexaenoic Acids'}], 'ancestors': [{'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'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D009829', 'term': 'Oleic Acids'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-11', 'studyFirstSubmitDate': '2014-02-05', 'studyFirstSubmitQcDate': '2014-02-10', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of Metabolic parameters in postprandial state', 'timeFrame': 't = 0, 2, 3, 4 and 6 hours', 'description': 'Glucose, insulin, C-peptide, triglyceride, and NEFA levels in plasma will be measured at several time-points postprandially (t = 0, 2, 3, 4, and 6 h) using routine biochemical procedures. Different empiric indices of postprandial β-cell function and insulin sensitivity will be determined.'}, {'measure': 'Evolution of Inflammatory markers in postprandial state', 'timeFrame': 't = 0, 2, 3, 4 and 6 hours', 'description': 'Inflammatory markers will be measured in plasma at several time-points postprandially (t = 0, 2, 3, 4, and 6 h) using appropriate methods (EIA, ELISA, and/or Bioplex multiplex system), and will include NAMPT, the acute phase protein (hsCRP), PAI-1, fibrinogen, transferrin, albumin, MPO (myeloperoxidase), and cytokines such as TNFα, IL-1β, IL-6, IL-8, IL-10, ICAM-1, MCP-1, leptin, and adiponectin, among other markers. For NAD+ content in plasma at fasting and postprandially, we will add 0.5 M ice-cold HClO4 to samples; after 2 min, we will collect 100 μL of supernatants by centrifugation at 3,000 g for 5 min, add 20 μL K2HPO4 (1 M) with cooling on ice and adjust pH to 7.2-7.4 with KOH. We will add 50 μL of supernatant to the reaction mixture containing 0.1 M sodiumpyrophosphate-semicarbazid (pH 8.8), absolute ethanol, and dH2O. We will assess NAD+ spectrophotometrically at 339 nm at 25 °C, as a mean difference in absorbance before and 6 min after addition of alcohol dehydrogenase.'}, {'measure': 'Pharmacokinetic of Niacin and its metabolites', 'timeFrame': 't = 0, 2, 3, 4 and 6 hours.', 'description': 'Quantitation of nicotinic acid and its metabolites (nicotinamide, nicotinuric acid, and N-methyl-2-pyridone-5-carboxamide) will be assessed in postprandial plasma by LC-MS/MS.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metabolic Syndrome', 'Olive Oil', 'Niacin'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The metabolic syndrome may be defined as the constellation of cardiovascular disease (CVD) risk factors that comprises obesity, type 2 diabetes, dyslipidemia, and hypertension. Lack of habitual physical activity and certain dietary patterns, including high-saturated fatty acids (SFA) intake, contribute to increase the risk of CVD, whereas the greatest risk reduction is related with monounsaturated fatty acids (MUFA), mainly from olive oil, and omega-3 polyunsaturated fatty acids (PUFA). Vitamin B3, as a major substrate for nicotinamide phosphoribosyltransferase (NAMPT), has also emerged as a nutritional intervention strategy for prevention of CVD.\n\nNAMPT has been shown to exert activities of central importance to cellular energetics and innate immunity. Within the cell, NAMPT is the rate-limiting step in a salvage pathway of nicotinamide adenine dinucleotide (NAD+) biosynthesis. By virtue of this role, it can regulate cellular levels of NAD+ and thereby NAD+-consuming enzymes. NAMPT is also released by a variety of cells, and elevated levels can be found in the systemic circulation of subjects with a range of inflammatory disorders.\n\nRecent evidences suggest that, primarily due to its high MUFA content, olive oil is useful as an optimal fat for the modulation of CVD risk factors in the postprandial state. In addition, NAMPT has been shown to correlate with triglycerides in the fasting plasma, and a potential regulatory role for fatty acids on NAMPT expression has been proposed.\n\nThe global aim of the project is to assess whether olive oil (MUFA), compared to other dietary fatty acids (SFA and omega-3 PUFA) and in association with vitamin B3 could have benefits on NAMPT-related inflammation and atherosclerosis. We hope to provide important novel insights on the relationship among dietary fatty acids, NAD+ metabolism, and metabolic syndrome. This aim is expected to be achieved in one principal objective:\n\nTo elucidate the influence of olive oil (MUFA), butter (SFA) or fish oil (omega-3 PUFA) meals supplemented by vitamin B3 on postprandial NAMPT modulation and its involvement on leukocyte inflammatory response in subjects with metabolic syndrome.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of metabolic syndrome\n\nExclusion Criteria:\n\n* Subjects will be excluded if, allergic to dairy products, allergic to fish oil, vegetarian, tobacco smoker, current or recent (\\<4 wk) use of fish oil supplements or more than four times fish/week, received innoculations within 2 mo of starting the study or planned to during the study, donated or intended to donate blood from 2 mo before the study till 2 mo after the study, unstable body weight (no weight gain/loss \\>3 kg), medical condition that can interfere with the study outcome (i.e., biochemical evidence of active heart disease, renal impairment, hypothyroidism, liver dysfunction, etc.), use of medications know to interfere with glucose homeostasis or lipid metabolism, use of anti-inflammatory medication, hormone or cytokine or growth factor therapies, abuse of drugs and/or alcohol, participation in another biomedical study within 1 mo before the first screening visit, or not wanting to be informed about chance-findings during screening. Another exclusion criteria will be severe diabetes, which requires application of insuin and diabetes-related complications.'}, 'identificationModule': {'nctId': 'NCT02061267', 'acronym': 'OLNAMS', 'briefTitle': 'Olive Oil and Nampt on Postprandial Inflammation and Atherosclerosis in the Setting of Metabolic Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Research Council, Spain'}, 'officialTitle': 'OLIVE OIL ON NAMPT AND ITS RELATION WITH POSTPRANDIAL INFLAMMATION AND ATHEROSCLEROSIS IN THE SETTING OF METABOLIC SYNDROME. The OLNAMS Project', 'orgStudyIdInfo': {'id': 'AGL2011-29008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Niacin Control', 'description': 'The subjects will receive a vitamin B3 supplement (2 g)', 'interventionNames': ['Dietary Supplement: Niacin']}, {'type': 'EXPERIMENTAL', 'label': 'Niacin + SAT', 'description': 'The subjects will receive a vitamin B3 supplement (2 g) and a test meal with high-fat (containing 72% saturated fat, 22% carbohydrate, and 6% protein)', 'interventionNames': ['Dietary Supplement: Niacin', 'Dietary Supplement: Saturated meal']}, {'type': 'EXPERIMENTAL', 'label': 'Niacin + ROO', 'description': 'The subjects will receive a vitamin B3 supplement (2 g) and a test meal with high-fat (containing 72% monounsaturated fat, 22% carbohydrate, and 6% protein)', 'interventionNames': ['Dietary Supplement: Niacin', 'Dietary Supplement: Monounsaturated meal']}, {'type': 'EXPERIMENTAL', 'label': 'Niacin + O3', 'description': 'The subjects will receive a vitamin B3 supplement (2 g) and a test meal with high-fat (containing 72% polyunsaturated omega-3 fat, 22% carbohydrate, and 6% protein)', 'interventionNames': ['Dietary Supplement: Niacin', 'Dietary Supplement: Polyunsaturated meal']}], 'interventions': [{'name': 'Niacin', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Vitamine B3', 'Nicotinic Acid'], 'description': 'The subjects will receive a vitamin B3 supplement (2 g)', 'armGroupLabels': ['Niacin + O3', 'Niacin + ROO', 'Niacin + SAT', 'Niacin Control']}, {'name': 'Saturated meal', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Butter', 'Saturated fat'], 'description': 'Test meal with high-fat (containing 72% saturated fat, 22% carbohydrate, and 6% protein)', 'armGroupLabels': ['Niacin + SAT']}, {'name': 'Monounsaturated meal', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Refined olive oil', 'olive oil', 'oleic acid'], 'description': 'Test meal with high-fat (containing 72% monounsaturated fat, 22% carbohydrate, and 6% protein)', 'armGroupLabels': ['Niacin + ROO']}, {'name': 'Polyunsaturated meal', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Fish oil', 'Omega-3', 'DHA', 'EPA'], 'description': 'Test meal with high-fat (containing 72% polyunsaturated omega-3 fat, 22% carbohydrate, and 6% protein)', 'armGroupLabels': ['Niacin + O3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41012', 'city': 'Seville', 'country': 'Spain', 'facility': 'Instituto de la Grasa, CSIC', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Francisco José García Muriana, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Research Counsil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Council, Spain', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Scientific Research Francisco Jose Garcia Muriana', 'investigatorFullName': 'Francisco Jose Garcia Muriana', 'investigatorAffiliation': 'National Research Council, Spain'}}}}