Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2026-01-07 @ 4:04 PM
Study NCT ID:
NCT03032861
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2017-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prebiotic Effect of Daily Intake of Orange Juice Affects the Bioavailability of Flavanones?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007410', 'term': 'Intestinal Diseases'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2017-01-06', 'studyFirstSubmitQcDate': '2017-01-24', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total counting of aerobic bacteria and facultative anaerobic bacteria', 'timeFrame': '4 months'}, {'measure': 'Determination of butyric acid', 'timeFrame': '4 months'}, {'measure': 'Determination of acetic acid', 'timeFrame': '4 months'}, {'measure': 'Ammonium concentration', 'timeFrame': '4 mounths'}], 'secondaryOutcomes': [{'measure': 'Bioavailability of hesperitin and naringenin in the blood, urine and feces', 'timeFrame': '4 months', 'description': 'Quantification of hesperidin and naringenin and identification and quantification of their metabolites in the blood, urine and feces'}, {'measure': 'Body mass index', 'timeFrame': '4 months'}, {'measure': 'Body lean mass', 'timeFrame': '4 months'}, {'measure': 'Body fat mass', 'timeFrame': '4 months'}, {'measure': '% body fat', 'timeFrame': '4 months'}, {'measure': 'Ratio waist/hip', 'timeFrame': '4 mounths'}, {'measure': 'Glucose', 'timeFrame': '4 mounths'}, {'measure': 'Insulin', 'timeFrame': '4 mounths'}, {'measure': 'Total cholesterol', 'timeFrame': '4 mounths'}, {'measure': 'Low density lipoprotein cholesterol', 'timeFrame': '4 mounths'}, {'measure': 'High density lipoprotein cholesterol', 'timeFrame': '4 mounths'}, {'measure': 'Triglycerides', 'timeFrame': '4 mounths'}, {'measure': 'hsCRP', 'timeFrame': '4 mounths'}, {'measure': 'Alkaline phosphatase', 'timeFrame': '4 mounths'}, {'measure': 'Aspartate enzyme aminotransferase', 'timeFrame': '4 mounths'}, {'measure': 'Alanine enzyme aminotransferase', 'timeFrame': '4 mounths'}, {'measure': 'GammaGT', 'timeFrame': '4 mounths'}, {'measure': 'Glycemic curve', 'timeFrame': '4 mounths'}, {'measure': 'Insulin curve', 'timeFrame': '4 mounths'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Orange juice', 'Microbiota', 'Prebiotic', 'Flavanones', 'Bioavailability'], 'conditions': ['Intestinal Diseases']}, 'referencesModule': {'references': [{'pmid': '25495754', 'type': 'RESULT', 'citation': 'Silveira JQ, Cesar TB, Manthey JA, Baldwin EA, Bai J, Raithore S. Pharmacokinetics of flavanone glycosides after ingestion of single doses of fresh-squeezed orange juice versus commercially processed orange juice in healthy humans. J Agric Food Chem. 2014 Dec 31;62(52):12576-84. doi: 10.1021/jf5038163. Epub 2014 Dec 15.'}, {'pmid': '11234459', 'type': 'RESULT', 'citation': 'Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.'}, {'pmid': '17047689', 'type': 'RESULT', 'citation': 'Kanaze FI, Bounartzi MI, Georgarakis M, Niopas I. Pharmacokinetics of the citrus flavanone aglycones hesperetin and naringenin after single oral administration in human subjects. Eur J Clin Nutr. 2007 Apr;61(4):472-7. doi: 10.1038/sj.ejcn.1602543. Epub 2006 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed investigate the chronic effect of orange juice consumption on gut microbiota and in the bioavailability of flavanones and metabolites by feces, blood and urine analysis.', 'detailedDescription': 'Non-randomized study with interrupted time series and open-label, in which women were enrolled and advised to not consumed foods containing prebiotic, probiotic and fibers, and citrus fruits and beverages during 30 days before of intervention (n=10; BMI 23.8 kg/m2; 28 years). After 30 days, the participants will consume during 60 days 300 mL of orange juice daily. After 60 days of orange juice intervention, the participants will be submitted to 30 days of washout. Samples of blood, urine and feces will collect in five different occasions (baseline, 30 day, 60 day, 90 day, and 120 day) in order to evaluate the prebiotic effect of orange juice on gut microbiota and in the bioavailability of its flavanones. The recruitment process began in September 2016 and the intervention was carried out from October 2016 to February 2017, and the data analysis will start in February 2017. The sample number took into account variances on blood hesperitin levels with a type I error α = 0.05 and a type II error β = 0.2 (80% power) (Silveira et al., 2015). The minimum sample size should have six individuals into the same group. Considering an approximately 15% dropout rate, the final sample size of study was constituted by 10 women. Primary endpoint is the changes in total bacteria population (Lactobacillus spp., Bifidobacterium spp., and reduction of Clostridium spp.) that can result in increased of butyric, acetic, and propionic acid concentrations, and reduction of ammonium production. Secondary endpoint is enhancement of bioavailability of flavanones (hesperitin, naringenin) and metabolites in the blood, urine and feces. Kolmogorov Smirnov and Levene test will be used to assess the normality and homogeneity of data, respectively. One-way analysis of variance (ANOVA) will be apply to determine the intervention effect over the time 0, 30 day, 60 day, 90 day, and 120 day). P significance was set up ≤ 0.05.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy women BMI 18.5 - 29.9 kg/m2.\n\nExclusion Criteria:\n\nGastrointestinal diseases Pregnant women Regular use of medications Dietary restrictions, vegetarian diet, macrobiotic, etc. Use of vitamins or dietary supplements Use of probiotics or prebiotics in the last 3 months and antibiotics in the last 6 months.'}, 'identificationModule': {'nctId': 'NCT03032861', 'briefTitle': 'The Prebiotic Effect of Daily Intake of Orange Juice Affects the Bioavailability of Flavanones?', 'organization': {'class': 'OTHER', 'fullName': 'São Paulo State University'}, 'officialTitle': 'Influence of the Prebiotic Effect of Orange Juice on the Bioavailability of Flavanones After Chronic Intake of Orange Juice.', 'orgStudyIdInfo': {'id': 'SaoPSU2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Orange juice', 'description': 'Ten women will consume 100% orange juice (300 mL/day) during 60 days.', 'interventionNames': ['Other: Orange juice']}], 'interventions': [{'name': 'Orange juice', 'type': 'OTHER', 'description': 'Thirty days before the beginning of trial, women (n= 10; BMI 23.8 kg/m2; 28 years) will be advised to not consumed foods containing prebiotic, probiotic and fibers, and citrus fruits and beverages. After 30 days, the participants will consume 300 mL of orange juice daily during 60 days. After 60 days of orange juice intervention, the participants will be submitted to 30 days of washout. Samples of blood, urine and feces will collect in five different occasions (baseline, 30 day, 60 day, 90 day, and 120 day) in order to evaluate the prebiotic effect of orange juice on gut microbiota and the bioavailability of its flavanones in blood, urine and feces.', 'armGroupLabels': ['Orange juice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14800-903', 'city': 'Araraquara', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas', 'geoPoint': {'lat': -21.79444, 'lon': -48.17556}}], 'overallOfficials': [{'name': 'Thais B Cesar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'São Paulo State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'There is still no decision regarding if the individual participant data (IPD) will be available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'São Paulo State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Thais Cesar', 'investigatorAffiliation': 'São Paulo State University'}}}}