Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-28 @ 1:50 AM
Study NCT ID:
NCT05786534
Status:
UNKNOWN
Last Update Posted:
2023-09-29
First Post:
2023-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Effect of Green Seaweed Against Metabloc 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': 'D050171', 'term': 'Dyslipidemias'}], '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': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, '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': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-11-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-28', 'studyFirstSubmitDate': '2023-03-03', 'studyFirstSubmitQcDate': '2023-03-14', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure will be assessed before and after the trial', 'timeFrame': '40 days', 'description': 'The change in blood pressure, after consuming green seaweed powder for 40 days, will be assessed. The values will become close to optimized levels.'}, {'measure': 'Lipid profile will be assessed before and after the trial', 'timeFrame': '40 days', 'description': 'The improvement in lipid profile, after consuming green seaweed powder for 40 days, will be assessed. The values will become close to optimized values.'}, {'measure': 'Fasting glucose level will be assessed before and after the trial', 'timeFrame': '40 days', 'description': 'The change in fasting glucose levels will be assessed, after consuming green seaweed powder for 40 days. The values will become close to optimized levels.'}, {'measure': 'Weight will be measured before and after the trial', 'timeFrame': '40 days', 'description': 'The change in weight will be measured, after consuming green seaweed powder for 40 days. BMI will become close to normal range.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metabolic Syndrome', 'Hypertension', 'Diabetes', 'Obesity', 'Dyslipidemia', 'Seaweed'], 'conditions': ['Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '26569268', 'type': 'RESULT', 'citation': 'Cardoso SM, Pereira OR, Seca AM, Pinto DC, Silva AM. Seaweeds as Preventive Agents for Cardiovascular Diseases: From Nutrients to Functional Foods. Mar Drugs. 2015 Nov 12;13(11):6838-65. doi: 10.3390/md13116838.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/26569268/', 'label': 'Seaweeds as Preventive Agents for Cardiovascular Diseases'}]}, 'descriptionModule': {'briefSummary': 'Metabolic syndrome is a major concern worldwide and in Pakistan as well. Metabolic syndrome is a pathologic condition which includes abdominal obesity, insulin resistance, hypertension and hyperlipidemia. Seafood consumption has been linked to reduced risk of many health conditions including altered blood profile. Green seaweed is known to have a potential in optimizing the blood profile and so, it is helpful in reducing the risk of metabolic syndrome by playing a role in preventing obesity, hyperglycemia, high blood pressure and altered lipid profile. Green seaweed (Ulva Lactuca) powder will prove to have therapeutic potential against obesity, hypertension, glucose intolerance and dyslipidemia.', 'detailedDescription': 'Metabolic syndrome is a major concern worldwide and in Pakistan as well. Metabolic syndrome is a pathologic condition which includes abdominal obesity, insulin resistance, hypertension and hyperlipidemia. Seafood consumption has been linked to reduced risk of many health conditions including altered blood profile. Green seaweed is known to have a potential in optimizing the blood profile and so, it is helpful in reducing the risk of metabolic syndrome by playing a role in preventing obesity, hyperglycemia, high blood pressure and altered lipid profile.\n\nStatement of problem: The number of people with high LDL-cholesterol, body mass index and fasting plasma glucose levels has been increasing. These factors are promoting the risk of metabolic syndrome in Pakistan. 26-38% people in Pakistan are reported to be a patient of metabolic syndrome. Seaweed has shown to be protective against the syndrome in previous studies. The goal of this study is to check the role of green seaweed against metabolic syndrome.\n\nHypothesis: Green seaweed (Ulva Lactuca) has a potential to manage metabolic syndrome.\n\nObjective: To assess the therapeutic effect of green seaweed (Ulva Lactuca) against metabolic syndrome.\n\nMethodology: Green seaweed powder will be procured from Taokaenoi Food and Marketing Public Co., Ltd. (Thailand). The proximate analysis of the product will be performed and then capsules of powder will be prepared to be consumed by the participants. Total 40 subjects (20 in treatment group and 20 in control group) will be selected and green seaweed powder will be added in their diets (200mg twice a day). After a trial of 40 days, the patients will be assessed. Assessment will include anthropometric measurements, blood pressure, lipid profile analysis and total antioxidant capacity (TAC) which will be monitored before and after the trial and final,ly, the data collected will be analyzed by using SPSS 25 by paired sample t test. P value ≤ 0.05 will be considered significant.\n\nExpected outcomes: Green seaweed (Ulva Lactuca) powder will prove to have therapeutic potential against obesity, hypertension, glucose intolerance and dyslipidemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 25kg/m2\n* Dyslipidemia\n* Altered blood glucose level\n* Age 30-55 ( male and female)\n\nExclusion Criteria:\n\n* Thyroid disorder\n* Liver disease\n* Kidney disorder\n* Cancer etc'}, 'identificationModule': {'nctId': 'NCT05786534', 'briefTitle': 'Therapeutic Effect of Green Seaweed Against Metabloc Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Veterinary and Animal Sciences, Lahore - Pakistan'}, 'officialTitle': 'Therapeutic Potential of Green Seaweed, Ulva Lactuca, Against Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'Green Seaweed'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metabolic Syndrome patients', 'description': 'Green seaweed Ulva Lactuca is used for preventing symptoms in Metabolic Syndrome patients', 'interventionNames': ['Dietary Supplement: Green Seaweed']}], 'interventions': [{'name': 'Green Seaweed', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Ulva Lactuca'], 'description': '400 mg per day', 'armGroupLabels': ['Metabolic Syndrome patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52250', 'city': 'Chak Two Hundred Fourteen', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Ashraf Hospital', 'geoPoint': {'lat': 31.29188, 'lon': 72.53995}}]}, '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': 'Researcher', 'investigatorFullName': 'Asif Ali', 'investigatorAffiliation': 'University of Veterinary and Animal Sciences, Lahore - Pakistan'}}}}