Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-29 @ 10:20 PM
Study NCT ID:
NCT06092632
Status:
UNKNOWN
Last Update Posted:
2023-10-30
First Post:
2023-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Pigmented Rice on Reducing Cardiometabolic Risk Factors Among Filipino Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-26', 'studyFirstSubmitDate': '2023-10-10', 'studyFirstSubmitQcDate': '2023-10-14', 'lastUpdatePostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Lipid Levels', 'timeFrame': 'six weeks', 'description': 'Total cholesterol, Low-density lipoprotein, high-density lipoprotein, triglycerides'}, {'measure': 'Change in Glucose Level', 'timeFrame': 'Six weeks', 'description': 'Fasting blood glucose'}], 'secondaryOutcomes': [{'measure': 'Change in Weight (kg)', 'timeFrame': 'Six weeks', 'description': 'Weight in kilograms'}, {'measure': 'Change in Waist Circumference (cm)', 'timeFrame': 'six weeks', 'description': 'Waist circumference in centimeters'}, {'measure': 'Change in Hip Circumference (cm)', 'timeFrame': 'Six weeks', 'description': 'Hip Circumference in centimeters'}, {'measure': 'Change in Waist:Hip (W:H ratio)', 'timeFrame': 'Six weeks', 'description': 'Waist and hip measurement will be combined to report W:H ratio'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pigmented rice', 'dyslipidemia', 'hyperglycemia'], 'conditions': ['Dyslipidemias', 'Overweight or Obesity', 'Hyperglycaemia (Non Diabetic)']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this clinical trial is to investigate whether the consumption of pigmented rice (black rice) in the diet improves cardiovascular health, specifically body weight, lipids, and glucose levels. It also aims to know whether people enjoyed eating pigmented rice and if they would continue eating it.', 'detailedDescription': "The goal of this clinical trial is to test if pigmented rice consumption can lower the cardiometabolic risk factors of adults. The main question\\[s\\] it aims to answer are:\n\n* Will pigmented rice significantly reduce lipid levels compared to white rice after six weeks?\n* Will pigmented rice significantly reduce glucose levels compared to white rice after six weeks? Will pigmented rice significantly reduce weight and waist-hip ratio levels compared to white rice after six weeks? What are the participants' experiences in consuming pigmented rice?\n\nParticipants will consume black-pigmented rice for six weeks while maintaining their usual physical activity. Researchers will compare the white rice group and the black rice group to see if lowers cardiometabolic risk factors."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 20-59 years.\n* Body mass index between 18.5 -35 kg/m2\n* Elevated cholesterol (total cholesterol \\>200 mg/dL or LDL cholesterol 130-190 mg/dL), and/or impaired fasting glucose (100-125mg/dL)\n* Eat rice as a staple food at least twice per day\n\nExclusion Criteria:\n\n* Are pregnant or lactating\n* Regularly consume pigmented rice (two meals per day in the past 4 weeks)\n* Have cardiovascular disease (hypertension, stroke, ischemic heart disease, myocardial infarction, or congestive heart failure) or diabetes mellitus\n* Take cholesterol or glucose-lowering medications\n* Have elevated blood pressure (\\>130/80 mmHg)\n* Have an illness that may influence lipid metabolism or metabolic rate (liver cirrhosis, pancreatitis, chronic kidney disease, hyperthyroidism, hypothyroidism)\n* Take supplements that may influence lipids and glucose levels (including polyphenols)\n* Are on a strict diet regimen (calorie-restricted or excluding food groups, examples: (Examples: Ketogenic diet, Intermittent fasting, No Rice diet)\n* Have an active lifestyle (Ex. Goes to the gym daily, regularly (≥3 times a week) and perform vigorous activities such as lifting weights, swimming, cycling fast or uphill, or running, or athlete)'}, 'identificationModule': {'nctId': 'NCT06092632', 'briefTitle': 'Efficacy of Pigmented Rice on Reducing Cardiometabolic Risk Factors Among Filipino Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Santo Tomas'}, 'officialTitle': 'Efficacy of Pigmented Rice on Reducing Cardiometabolic Risk Factors Among Filipino Adults', 'orgStudyIdInfo': {'id': 'USantoTomas'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pigmented Rice', 'description': 'Cooked black pigmented rice will be consumed for six weeks (twice per day)', 'interventionNames': ['Other: Pigmented rice']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'White Rice', 'description': 'Cooked white rice will be consumed by the control group for six weeks (twice per day)', 'interventionNames': ['Other: White Rice']}], 'interventions': [{'name': 'Pigmented rice', 'type': 'OTHER', 'otherNames': ['Black Rice'], 'description': 'Cooked black rice', 'armGroupLabels': ['Pigmented Rice']}, {'name': 'White Rice', 'type': 'OTHER', 'description': 'Cooked white rice', 'armGroupLabels': ['White Rice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1015', 'city': 'Manila', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'University of Santo Tomas', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}], 'overallOfficials': [{'name': 'Alison M Hill, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Australia'}, {'name': 'Elizabeth H Arenas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Santo Tomas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Santo Tomas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Diane S. Mendoza-Sarmiento', 'investigatorAffiliation': 'University of Santo Tomas'}}}}