Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-02-25 @ 4:58 AM
Study NCT ID:
NCT05483192
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2022-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Oral Dyglomera™ on Body Fat and Blood Lipids of Overweight and Obese Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'To maintain double-blinding, in addition to the contents mentioned in the production/packaging and labeling of the products used in the human study, the allocation details of unique codes (information on blinding) for each group will be managed in a sealed state by the principal investigator. Except in cases where it is unavoidably necessary to read the code due to the occurrence of a serious adverse drug reaction\\*, it will not be disclosed until the end of the human study. In this human study, no unblinding will occur during the study. The investigator will supply the investigational products that match the randomization code assigned to the selected subject, and maintain blinding by using an extra (by unique code) when the investigational product is defective or damaged.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '12-week randomized, double-blind, placebo-controlled trial with subjects administered 400 mg per day of Dyglomera'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2022-07-19', 'studyFirstSubmitQcDate': '2022-08-01', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Dyglomera on body fat of overweight and obese people', 'timeFrame': '12 weeks', 'description': 'DEXA and impedance measurement of body fat'}], 'secondaryOutcomes': [{'measure': 'Effect of Dyglomera on blood cholesterol levels of overweight and obese people', 'timeFrame': '12 weeks', 'description': 'Blood assay to measure blood total cholesterol'}, {'measure': 'Effect of Dyglomera on blood triglyceride levels of overweight and obese people', 'timeFrame': '12 weeks', 'description': 'Blood assay to measure blood total triglycerides'}, {'measure': 'Effect of Dyglomera on HDL-cholesterol levels of overweight and obese people', 'timeFrame': '12 weeks', 'description': 'Blood assay to measure HDL-cholesterol'}, {'measure': 'Effect of Dyglomera on fasting blood glucose levels', 'timeFrame': '12 weeks', 'description': 'Blood assay to measure fasting blood glucose'}, {'measure': 'Effect of Dyglomera on CRP levels of overweight and obese people', 'timeFrame': '12 weeks', 'description': 'Blood assay to measure CRP'}, {'measure': 'Effect of Dyglomera on ALT levels of overweight and obese people', 'timeFrame': '12 weeks', 'description': 'Blood assay to measure ALT'}, {'measure': 'Effect of Dyglomera on AST levels of overweight and obese people', 'timeFrame': '12 weeks', 'description': 'Blood assay to measure blood AST'}, {'measure': 'Effect of Dyglomera on leptin levels of overweight and obese people', 'timeFrame': '12 weeks', 'description': 'Blood assay to measure leptin'}, {'measure': 'Effect of Dyglomera on adiponectin levels of overweight and obese people', 'timeFrame': '12 weeks', 'description': 'Blood assay to measure blood adiponectin'}, {'measure': 'Effect of Dyglomera on blood insulin levels of overweight and obese people', 'timeFrame': '12 weeks', 'description': 'Blood assay to measure insulin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Body fat', 'Dyglomera', 'Blood lipids'], 'conditions': ['Body Fat Disorder']}, 'descriptionModule': {'briefSummary': 'The extract of Dichrostachys glomerata (DyglomeraTM), has been reported to be effective in weight reduction in obese patients with metabolic syndrome. This plant has been shown to have many biological properties and has been reported to have no toxic or adverse side effects in animals. The purpose of this human study was to prove that the effect of reducing body fat percentage (%) after 12 weeks of intake was superior to that of the control group.', 'detailedDescription': 'This is a 12-weeks randomized double-blind placebo controlled trial. 120 number of subjects are planned. Each subject will be administered a single dose of the investigational product once daily, before lunch or dinner, consisting each time of 400 mg of the test product or placebo. Subjects will be assigned to the test group or placebo group in random order. Evaluations will be taken at baseline and at the beginning of each of the 5 study visits.\n\nScreening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.\n\nThe following investigational products will be used:\n\n* Test product: Dichrostachys glomerata extract (Dyglomera™) at a dose of 400 mg\n* Control product: Placebo at a dose of 400 mg In this human study, starting with Visit 2, the duration of participation in the human study will be 12 weeks (84 days) in total. The study period will be planned to be 8 months from the date of approval of the human study. The screening visit of the first subject will be conducted at the MAX SPECIALTY HOSPITAL, and the first subject will be enrolled thereafter. The last subject will complete the study within about 5 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged from 19 to 65 years old,\n* Patients with a BMI ranging between 25 and 34.9 kg/m2,\n* Patients available for the entire period of study .\n\nExclusion Criteria:\n\n* Patients that has an age below 19 years old and greater than 65 years old,\n* Patients not available for the study period,\n* Specific exclusion criteria included: morbid obesity (BMI \\> 34.9 kg/m2); diabetes mellitus requiring daily insulin management; pregnancy/lactation; active infection; and systemic disease such as HIV/AIDS, active hepatitis or clinical signs of active malignancy within the past 5 years. Other exclusion criteria will include having taken any other medications or any natural health product within 1 month prior to the screening visit.'}, 'identificationModule': {'nctId': 'NCT05483192', 'acronym': 'Dyglomera', 'briefTitle': 'Impact of Oral Dyglomera™ on Body Fat and Blood Lipids of Overweight and Obese Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gateway Health Alliance'}, 'officialTitle': 'Evaluation the Impact of Oral Dichrostachys Glomerata Extract (Dyglomera™) in Overweight and Obese Adults for Reducing Body Fat and Modulating Blood Parameters a Randomized, Double-blind, Placebo-controlled Study', 'orgStudyIdInfo': {'id': '2021/11/049204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Comparison between placebo and active treatment', 'description': '120 subjects were planned. Screening data was reviewed to determine subject eligibility. Subjects who met all inclusion criteria and none of the exclusion criteria were enrolled into the study.\n\nThe following investigational products were used:\n\n* Test product: Dichrostachys glomerata extract (Dyglomera™) at a dose of 400 mg\n* Control product: Placebo at a dose of 400 mg Subjects were assigned to the test group or placebo group in random order. Each subject was administered a single 400 mg dose of Dyglomera or placebo once daily, before lunch or dinner. Measurements were taken at baseline and at the beginning of each of the 5 study visits.', 'interventionNames': ['Dietary Supplement: Oral Dyglomera']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparison of baseline to final outcome', 'description': 'The effect of Dyglomera on body fat and blood parameters were compared at baseline and at the end of the intervention period.', 'interventionNames': ['Dietary Supplement: Oral Dyglomera']}], 'interventions': [{'name': 'Oral Dyglomera', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Placebo'], 'description': 'Measurement of body weight, waist circumference, hip circumference, waist to hip ratio, body mass index, body fat.\n\nBlood draw and measurement of blood total Cholesterol, HDL-cholesterol, LDL-cholesterol), ALT, AST, Fasting Blood Glucose, CRP, adiponectin, and leptin.', 'armGroupLabels': ['Comparison between placebo and active treatment', 'Comparison of baseline to final outcome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110092', 'city': 'New Delhi', 'state': 'Patparganj', 'country': 'India', 'facility': 'Max Super Specialty Hospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}]}, 'ipdSharingStatementModule': {'url': 'http://www.gha.org', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis', 'ipdSharing': 'YES', 'description': 'Data obtained through this study may be provided to qualified researchers with academic interest in the management of overweight and obese people. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.', 'accessCriteria': 'Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gateway Health Alliance', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}