Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-02-20 @ 6:35 PM
Study NCT ID:
NCT01290250
Status:
COMPLETED
Last Update Posted:
2013-03-15
First Post:
2010-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a New Orange-Based Beverage Enriched With Polyphenols in Adult Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059808', 'term': 'Polyphenols'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-14', 'studyFirstSubmitDate': '2010-12-21', 'studyFirstSubmitQcDate': '2011-02-03', 'lastUpdatePostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': '3 months'}, {'measure': 'Fasting Plasma Insulin Concentration', 'timeFrame': '3 months'}, {'measure': 'Fasting Plasma Triacylglycerols Concentration', 'timeFrame': '3 months'}, {'measure': 'Fasting Plasma High-Density Lipoprotein Cholesterol Concentration', 'timeFrame': '3 months'}, {'measure': 'Insulin resistance using HOMA (Homeostatic Model Assessment)index', 'timeFrame': '3 months', 'description': 'The HOMA index will be calculated as the product of the fasting plasma insulin level (mU/mL) and the fasting plasma glucose level (mmol/L), divided by 22.5'}, {'measure': 'Fasting Plasma glucose concentrations', 'timeFrame': '3 months'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Antioxidant defense system', 'timeFrame': '3 months', 'description': "Biomarkers of the non-enzymatic (NE-ADS) and enzymatic antioxidant defense system (E-ADS). For the NE-ADS, in addition to total plasma antioxidant capacity, malondialdhyde, and total carbonyl protein derivatives, plasma α-tocopherol, β-carotene, retinol, coenzyme Q and total blood glutathione will be determined. Furthermore, the amount of plasma oxidized LDL and urinary 8-hydroxy-2'-deoxyguanosine and F2-isoprostanes will be measured. For E-ADS the activities of glutathione reductase, glutathione peroxidase, superoxide dismutase, and catalase in red blood cells will be assessed."}, {'measure': 'Biomarkers of inflammation', 'timeFrame': '3 months', 'description': 'Biomarkers of inflammation: Interleukin-1 beta (IL-1β), interleukin-6 (IL-6), interleukin-8 (IL-8), matrix metalloproteinase-9 (MMP-9), monocyte chemotactic protein 1 (MCP-1)and polymorphonuclear neutrophils myeloperoxidase (MPO)'}, {'measure': 'Biomarkers of cardiovascular risk.', 'timeFrame': '3 months', 'description': 'Biomarkers of cardiovascular risk:soluble endothelial selectin (sE-selectin), soluble intercellular adhesion molecule 1 (sICAM-1), soluble vascular cell adhesion molecule (sVCAM-1), total and active tissue plasminogen activator inhibitor-1 (tPAI-1), tumor necrosis factor alpha (TNF-α).'}, {'measure': 'Metabolic analysis', 'timeFrame': '3 months', 'description': 'Gastrointestinal hormones involved in the control of satiety and insulin secretion i.e. active amylin, ghrelin (GHR), glucagon peptide-1 (GLP-1), gastric inhibitory peptide or gastric insulinotropic peptide (GIP), polypeptide YY 3-36, pancreatic polypeptide (PP).\n\nLikewise, adiponectin, leptin, resistin, visfatin, hepatocyte growth factor (HGF), nerve growth factor (NGF), retinol binding protein 4 (RBP4) and L-fatty acid binding protein (L-FABP) will be determined'}, {'measure': 'Gene expression analysis', 'timeFrame': '3 months', 'description': 'Whole genome gene expression analysis: This analysis will be carried out in a subset of 20 control and 20 experimental samples at four times: 160 arrays. The GeneChip® Human Exon 1.0 ST will be used for the gene expression analysis.\n\nValidation by Reverse transcription polymerase chain reaction (RTPCR): In order to confirm the arrays results, a total of 93 differentially expressed genes in the experimental samples will be analyzed by RTPCR using low density arrays'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Overweight', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '26136593', 'type': 'DERIVED', 'citation': 'Rangel-Huerta OD, Aguilera CM, Martin MV, Soto MJ, Rico MC, Vallejo F, Tomas-Barberan F, Perez-de-la-Cruz AJ, Gil A, Mesa MD. Normal or High Polyphenol Concentration in Orange Juice Affects Antioxidant Activity, Blood Pressure, and Body Weight in Obese or Overweight Adults. J Nutr. 2015 Aug;145(8):1808-16. doi: 10.3945/jn.115.213660. Epub 2015 Jul 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of a new orange juice-based beverage enriched in fiber and selected phenolic compounds (mainly flavanones) on features of metabolic syndrome and cardiovascular disease risk factors related to inflammation and antioxidant defense system in overweight and obese adult humans. This study hypothesizes that consumption of an orange juice-based beverage enriched in fiber and selected phenolic compounds (mainly flavanones)would improve lipid levels and lipid metabolism,blood pressure and the Homeostatic Model Assessment (HOMA) index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) higher than 25 (overweight or obese) but lower than 40 (extreme obesity) or waist circumference higher than 94 cm for men and 80 cm for women,\n\nand having altered at least two markers of MS namely:\n\n* Hypertension (diastolic pressure higher than 85 mmHg but lower than 110 mmHg)\n* Hyperglycemia (higher than 100 mg/dl but lower than 130 mg/dl)\n* Elevated plasma triacylglycerol concentrations (higher than 150 mg/dl)\n* Decreased plasma HDL-c levels (lower than 40 for men and 50 for women)\n* Volunteers will be otherwise healthy and without taking any medication aiming to lower either blood lipids, blood pressure or blood glucose concentrations.\n\nExclusion Criteria:\n\n* The presence of morbid obesity\n* Blood pressure higher than 110 mmHg\n* Plasma glucose levels higher than 130 mg/dl\n* The use of any medication for the control of blood pressure or glucose or lipid metabolism\n* Medical history of consumption of hypocaloric diet in the last year\n* Disorders of the food conduct\n* The presence of familiar dislipemias relatives of genetic character or the denial to take part in the study.'}, 'identificationModule': {'nctId': 'NCT01290250', 'acronym': 'BIONAOS', 'briefTitle': 'Evaluation of a New Orange-Based Beverage Enriched With Polyphenols in Adult Humans', 'organization': {'class': 'INDUSTRY', 'fullName': 'The Coca-Cola Company'}, 'officialTitle': 'Evaluation of a New Orange-Based Beverage Enriched With Polyphenols (Whole Press) on Features of Metabolic Syndrome and Cardiovascular Risk Factors Related to Inflammation and Antioxidant Defense System in Adult Humans', 'orgStudyIdInfo': {'id': 'BIONAOS-ORANGE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Orange juice based beverage enriched in polyphenols', 'description': '2 daily doses (250 ml each) during 3 months', 'interventionNames': ['Other: Orange juice based beverage enriched in polyphenols']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Orange juice with low levels of polyphenols', 'description': '2 daily doses (250 ml each) during 3 months', 'interventionNames': ['Other: Orange juice based beverage enriched in polyphenols']}], 'interventions': [{'name': 'Orange juice based beverage enriched in polyphenols', 'type': 'OTHER', 'description': '2 daily doses (250 ml each) during 3 months', 'armGroupLabels': ['Orange juice based beverage enriched in polyphenols', 'Orange juice with low levels of polyphenols']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18071', 'city': 'Granada', 'state': 'Granada', 'country': 'Spain', 'facility': 'Department of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology, Center for Biomedical Research, University of', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'Concepcion Aguilera, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Granada'}, {'name': 'Maria Dolores Mesa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Granada'}, {'name': 'Angel Gil, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidad de Granada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Coca-Cola Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Biochemistry and Molecular Biology', 'investigatorFullName': 'Concepcion Aguilera', 'investigatorAffiliation': 'Universidad de Granada'}}}}