Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT06780618
Status:
RECRUITING
Last Update Posted:
2025-01-24
First Post:
2025-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Brown Rice Compared to White Rice on Postprandial Changes in IL-6 and MDA Levels in Sedentary Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Effects of Brown Rice Consumption Compared to White Rice on Postprandial Changes in Interleukin-6 and Malondialdehyde Levels in Sedentary Workers', 'timeFrame': 'Enrollment process to fullfil sample size at 2 weeks. The intervention will be completed in 1 day.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['brown rice', 'white rice', 'interleukin-6', 'malondialdehyde', 'sedentary', 'inflammation', 'oxidative stress', 'postprandial'], 'conditions': ['Sedentary Employees', 'Postprandial Oxidation and inflammation']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn if brown rice and white rice affect oxidative stress and inflammation in office workers who don't exercise much. The main question it aims to answer is:\n\nDoes eating brown rice change MDA and IL-6 levels differently than eating white rice in people who don't exercise much?\n\nParticipants will:\n\nBe interviewed to collect personal data, medical history, lifestyle habits, and dietary patterns.\n\nBe measured to calculate Body Mass Index (BMI). Be interviewed to complete a questionnaire to assess their physical activity level in the past week.\n\nBe interviewed to record all food and beverages consumed in the past 24 hours. Blood samples will be drawn twice, before and after consuming the research meal.\n\nBe provided with a research meal consisting of rice (either brown or white), scrambled eggs, and tofu stew that must be finished within 15 to 20 minutes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* healthy administrative employees,\n* age 21-59 years,\n* normal body mass index (18.5-22.9 kg/m2),\n* low physical activity (≤600 METs minutes/week),\n* assign for informed consent\n\nExclusion Criteria:\n\n* being pregnant/breastfed/menopause,\n* consumption of herbal medicines and/or supplements within 24 hours before data collection,\n* having history of DM, CVD, cancer, and autoimmune disease,\n* being vegan,\n* smoking/alcohol drinking,\n* allergic to research food's ingredients"}, 'identificationModule': {'nctId': 'NCT06780618', 'briefTitle': 'The Effects of Brown Rice Compared to White Rice on Postprandial Changes in IL-6 and MDA Levels in Sedentary Workers', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Effects of Brown Rice Consumption Compared to White Rice on Postprandial Changes in Interleukin-6 and Malondialdehyde Levels in Sedentary Workers', 'orgStudyIdInfo': {'id': '24-10-1628'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'brown rice', 'interventionNames': ['Other: RICE']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'white rice', 'interventionNames': ['Other: rice wheat (placebo)']}], 'interventions': [{'name': 'RICE', 'type': 'OTHER', 'description': '150 g of brown rice from Aek Sibundong variant at once', 'armGroupLabels': ['brown rice']}, {'name': 'rice wheat (placebo)', 'type': 'OTHER', 'description': '150 g of white rice from Setra Ramos variant at once', 'armGroupLabels': ['white rice']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jakarta', 'state': 'Jakarta Special Capital Region', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Wulandari Taradita, MD', 'role': 'CONTACT', 'email': 'wulantardit@gmail.com', 'phone': '+62 82112409854'}, {'name': 'Rizqa F Putri, MD', 'role': 'CONTACT', 'email': 'rizqafebriliany@gmail.com', 'phone': '+62 81325090874'}, {'name': 'Wulandari Taradita, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rizqa F Putri, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Faculty of Medicine University of Indonesia', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'centralContacts': [{'name': 'Rizqa F Putri, MD', 'role': 'CONTACT', 'email': 'rizqafebriliany@gmail.com', 'phone': '+62 81325090874'}], 'overallOfficials': [{'name': 'Wulandari Taradita, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nutrition Faculty of Medicine University of Indonesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wulandari Taradita', 'investigatorAffiliation': 'Indonesia University'}}}}