Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-27 @ 7:05 PM
Study NCT ID:
NCT02077660
Status:
COMPLETED
Last Update Posted:
2014-03-12
First Post:
2014-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Green Tea Effect on Anthropometric, Oxidation and Inflammation Parameters in Physically Active vs. Sedentary Elders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-11', 'studyFirstSubmitDate': '2014-02-12', 'studyFirstSubmitQcDate': '2014-03-02', 'lastUpdatePostDateStruct': {'date': '2014-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma protein carbonyls', 'timeFrame': '24 weeks', 'description': 'Protein carbonyls, nmol/mg'}, {'measure': 'Plasma thiobarbituric acid reactive substance', 'timeFrame': '24 weeks', 'description': 'Thiobarbituric acid reactive substance , nmol/mL'}, {'measure': 'Plasma lipid peroxides', 'timeFrame': '24 weeks', 'description': 'Lipid peroxides, nmol/mL'}, {'measure': 'Erythrocytes catalase', 'timeFrame': '24 weeks', 'description': 'Catalase activity, milliunits/mg'}, {'measure': 'Erythrocytes resistance to oxidative hemolysis', 'timeFrame': '24 weeks', 'description': 'hemolysis test, percentage'}, {'measure': 'Saliva enzymatic antioxidants', 'timeFrame': '24 weeks', 'description': 'Oral peroxidase activity, milliunits/mg'}, {'measure': 'Saliva antioxidant capacity', 'timeFrame': '24 weeks', 'description': 'Total antioxidant capacity, millimolar/mg'}], 'secondaryOutcomes': [{'measure': 'Total body weight', 'timeFrame': '24 weeks', 'description': 'Body weight, kg'}, {'measure': 'Total body fat percentage', 'timeFrame': '24 weeks', 'description': 'Body fat, %'}, {'measure': 'Body circumference', 'timeFrame': '24 weeks', 'description': 'Waist and hip circumference, cm'}, {'measure': 'Serum inflammatory status', 'timeFrame': '24 weeks', 'description': 'Serum C-reactive protein mg/dL'}, {'measure': 'Saliva inflammatory status Saliva matrix metalloproteinase 8 (MMP8)', 'timeFrame': '24 weeks', 'description': 'Saliva matrix metalloproteinase 8, µg/L'}, {'measure': 'Saliva inflammatory status - saliva interleukin 8 (IL8)', 'timeFrame': '24 weeks', 'description': 'Saliva interleukin 8, ng/L'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Green tea, aging, oxidation, anthropometrics.'], 'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the beneficial effects of a long term (12 weeks) green tea drinking on plasma, erythrocytes and saliva oxidative stress biomarkers and antioxidant capacity, as well as on cardiometabolic risk factors: anthropometric, inflammation and metabolic parameters in a healthy aging men and women.', 'detailedDescription': 'A prospective, crossover trial in which every individual served its own control. All subjects undergo a four weeks washout period, during which they briefed to avoid tea drinking and antioxidant supplements until the end of the study. At the end of the washout period, blood and saliva samples is collected after 12 hours of night fast. Subsequently, all subjects receive the maltodextrin containing placebo "tea bags". The subjects instructed to brew the placebo sachets for five minute in 240 mL boiling water without stirring and to drink 4 cups per day for 12 weeks period (placebo period). After the placebo period, fasting samples collected once more and the subjects receive the green tea bags. Preparation and drinking instructions are the same as the placebo drink. At the end of the 12 weeks, green tea drinking, fasting blood and saliva samples drawn for the third time. During the study, every 4 weeks the subjects get additional placebo or green tea bags. Assessment of nutritional consumption of macronutrients and antioxidants using a food diary, physical activity lifestyle as well as weight, body fat and circumference measurements is made at the beginning, middle and end of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '76 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women\n* Age: 60-76 Years\n* Able to understand the meaning of Informed Consent procedure and willing to consent\n\nExclusion Criteria:\n\n* Any active disease state\n* Unstable chronic disease (diabetes, vascular, renal)'}, 'identificationModule': {'nctId': 'NCT02077660', 'acronym': 'GT', 'briefTitle': 'Green Tea Effect on Anthropometric, Oxidation and Inflammation Parameters in Physically Active vs. Sedentary Elders', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'The Effect of Green Tea on Anthropometric, Oxidation and Inflammation Parameters in Physically Active Elderly Compared to Sedentary Elderly', 'orgStudyIdInfo': {'id': '01'}, 'secondaryIdInfos': [{'id': 'Rambam MC', 'type': 'OTHER', 'domain': 'Rambam MC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '4 daily placebo tea bags for 12 weeks', 'description': 'All subjects will undergo a 12 weeks supplemented with four daily placebo maltodextrin "tea-bags". The subjects will be instructed than to brew the placebo sachets for five minute in 240 mL boiling water without stirring and to drink 4 cups per day for 12 weeks period (Placebo period).', 'interventionNames': ['Other: 4 daily placebo tea bags for 12 weeks']}, {'type': 'EXPERIMENTAL', 'label': 'Four green tea bags per day for 12 weeks', 'description': 'After the placebo period, all subjects will undergo a 12 weeks supplemented with four daily green tea bags. The subjects will be instructed than to brew the green tea sachets for five minute in 240 mL boiling water without stirring and to drink 4 cups per day for 12 weeks period (Green tea period).', 'interventionNames': ['Dietary Supplement: Four green tea bags per day for 12 weeks']}], 'interventions': [{'name': 'Four green tea bags per day for 12 weeks', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Four green tea bags per day for 12 weeks', 'armGroupLabels': ['Four green tea bags per day for 12 weeks']}, {'name': '4 daily placebo tea bags for 12 weeks', 'type': 'OTHER', 'description': '4 daily placebo tea bags for 12 weeks', 'armGroupLabels': ['4 daily placebo tea bags for 12 weeks']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam MC', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Yishai Levy, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}