Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
Study NCT ID:
NCT05956106
Status:
UNKNOWN
Last Update Posted:
2023-11-03
First Post:
2023-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Mulberry Fruit Powder in Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'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': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C569827', 'term': 'morniga G protein, Morus nigra'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Participants groups'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Case-Control Study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-02', 'studyFirstSubmitDate': '2023-07-13', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lipid profile will be assessed before and after the trial.', 'timeFrame': '45 days', 'description': 'The change in lipid profile, after consuming mulberry fruit powder for 45 days, will be assessed. The value will be closed to optimized values.'}, {'measure': 'Fasting glucose level will be assessed before and after the trial', 'timeFrame': '45 days', 'description': 'The change in fasting glucose levels will be assessed after consuming mulberry fruit powder for 45 days.The values will be become close to optimized levels'}, {'measure': 'Weight circumference will be measured before and after the trial', 'timeFrame': '45 days', 'description': 'The change in weight will be measured after consuming mulberry fruit powder for 45 days.The value will be close to normal range.'}, {'measure': 'Blood pressure will be assessed before and after the trial.', 'timeFrame': '45 days', 'description': 'The change in systolic and diastolic blood pressure, after consuming mulberry fruit powder for 45 days. The values will become close to optimized levels.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Diabetes', 'Obesity', 'Hyperlipidemia', 'Mulberry', 'Anthocyanin'], 'conditions': ['Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '35742014', 'type': 'RESULT', 'citation': 'Wan M, Li Q, Lei Q, Zhou D, Wang S. Polyphenols and Polysaccharides from Morus alba L. Fruit Attenuate High-Fat Diet-Induced Metabolic Syndrome Modifying the Gut Microbiota and Metabolite Profile. Foods. 2022 Jun 20;11(12):1818. doi: 10.3390/foods11121818.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/35742014/', 'label': 'Polyphenols and Polysaccharides from Morus alba L. Fruit Attenuate High-Fat Diet-Induced Metabolic Syndrome'}]}, 'descriptionModule': {'briefSummary': 'Metabolic syndrome is a raising concern globally, especially in developing countries such as Pakistan. To prevent its risk factors diet and lifestyle modification is major solution. Functional foods have additional benefits of treating disease while providing basic nutrients. Mulberry is a native fruit with the properties of functional food, it is rich in anthocyanin and different anti-obesity,anti-diabetic, and anti-hyperlipidemic treating potential antioxidants. Mulberry will prove its therapeutic potential against the risk factors of metabolic syndrome.', 'detailedDescription': 'Metabolic syndrome, which is characterized by a number of concurrent risk factors. These risk factors include dysglycemia, high blood pressure, high triglyceride levels, low levels of HDL cholesterol, and obesity (particularly central adiposity). It is rapidly increasing the burden of non-communicable diseases (NCDs) in Pakistan. The prevalence of MetS in Pakistan is 28.6%, and suburban areas from the province of Punjab showed a high prevalence. Females are more prone to metabolic syndrome. Dietary and lifestyle modification can prevent MetS from converting into CVD, T2DM, and stroke. There is limited documented research in Pakistan related to the therapeutic roles of mulberry fruit powder. With respect to these limitations, the present study aims to assess the therapeutic roles of mulberry fruit powder consumption on metabolic syndrome.\n\nThe utilization of dried mulberry fruit powder (MFP) as a component of nutritional supplementation will effectively ameliorate the clinical markers associated with metabolic syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects having fasting total cholesterol level of ≥ 200 mg/dl or LDL cholesterol ≥ 130 mg/dl.\n* Fasting Blood Glucose ≥110mg/dl.\n* SBP ≥ 130/ ≥ 85 mmHg\n* Waist Circumference of ≥40 inches in males and ≥35 inches for females\n\nExclusion Criteria:\n\n* Participants of age 55 or above\n* Participants who have less than two risk factors'}, 'identificationModule': {'nctId': 'NCT05956106', 'briefTitle': 'Effect of Mulberry Fruit Powder in Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Veterinary and Animal Sciences, Lahore - Pakistan'}, 'officialTitle': 'Therapeutic Effect of Mulberry Fruit Powder Consumption in Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'Mulberry Fruit Powder'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metabolic syndrome patients', 'description': 'Dried Mulberry fruit powder is used for preventing symptoms in Metabolic Syndrome patients Dietary intervention: Black Mulberry fruit powder Dosage: 45g per day', 'interventionNames': ['Dietary Supplement: Black Mulberry Fruit Powder']}], 'interventions': [{'name': 'Black Mulberry Fruit Powder', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Morus Nigra'], 'description': 'Anthocyanin plays a major role in preventing symptoms of metabolic syndrome.', 'armGroupLabels': ['Metabolic syndrome patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57450', 'city': 'Arifwala', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Dr. Muhammad Illyas, FCPS', 'role': 'CONTACT', 'phone': '+923075055198'}], 'facility': 'Shan Medicare Hospital', 'geoPoint': {'lat': 30.29058, 'lon': 73.06574}}], 'centralContacts': [{'name': 'Fiza Maqbool, DNS', 'role': 'CONTACT', 'email': 'fizach65@gmail.com', 'phone': '03008077414'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All available data will be confidential'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Veterinary and Animal Sciences, Lahore - Pakistan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer, Department of Food Sciences and Human Nutrition', 'investigatorFullName': 'Asif Ali', 'investigatorAffiliation': 'University of Veterinary and Animal Sciences, Lahore - Pakistan'}}}}