Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 11:00 PM
Study NCT ID:
NCT06114134
Status:
UNKNOWN
Last Update Posted:
2023-11-02
First Post:
2023-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Fenugreek Extract (Fenobet) on Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-01', 'studyFirstSubmitDate': '2023-10-09', 'studyFirstSubmitQcDate': '2023-11-01', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting blood sugar (FBS)', 'timeFrame': 'baseline and 2 months', 'description': 'Fasting blood sugar in mg/dL will be reported'}, {'measure': 'Hemoglobin A1C (HbA1C)', 'timeFrame': 'baseline and 2 months', 'description': 'HbA1C will be reported in percentage'}], 'secondaryOutcomes': [{'measure': 'Lipid profile', 'timeFrame': 'baseline and 2 months', 'description': 'Total Cholesterol'}, {'measure': 'Lipid profile', 'timeFrame': 'baseline and 2 months', 'description': 'Triglyceride'}, {'measure': 'Lipid profile', 'timeFrame': 'baseline and 2 months', 'description': 'High-density Cholesterol (HDL-C)'}, {'measure': 'Lipid profile', 'timeFrame': 'baseline and 2 months', 'description': 'Low-Density Cholesterol (LDL-C)'}, {'measure': 'Antropometric Indices', 'timeFrame': 'baseline and 2 months', 'description': 'Weight'}, {'measure': 'Antropometric Indices', 'timeFrame': 'baseline and 2 months', 'description': 'Body Mass Index'}, {'measure': 'Antropometric Indices', 'timeFrame': 'baseline and 2 months', 'description': 'Waist Circumference'}, {'measure': 'Antropometric Indices', 'timeFrame': 'baseline and 2 months', 'description': 'Hip Circumference'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome', 'Complementary Therapies', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The current study is a three-blind, randomized clinical trial study that will be conducted on 60 people with metabolic syndrome. The eligible participants were allocated randomly to one of the two study groups (Fenobet, Placebo). Then, the eligible people were in one of two groups 1) receiving fenugreek extract, 2), receiving placebos and were examined for 8 weeks. At baseline and after two months of intervention, biochemical parameters, and anthropometric indices will be measured.', 'detailedDescription': 'The current study is a three-blind, randomized clinical trial study that will be conducted on 60 people with metabolic syndrome. According to the ATP criteria, a person who has at least 3 of the following 5 components was considered as metabolic syndrome.\n\nAfter providing the necessary information about the study to patients, written informed consent will be obtained from eligible volunteers.\n\nInclusion criteria:\n\n* People with metabolic syndrome\n* Fasting sugar above 100 mg/dL\n* Both men and women\n* Age range 20-60 years Exclusion criteria\n* Injection of insulin or liraglutide\n* People under 20 years old and over 60 years old\n* having chronic cardiovascular diseases, chronic liver and kidney diseases, uncontrolled thyroid disorders and malignancies including cancer\n* Taking herbal medicines or herbs to control blood sugar and fat in the last 6 months\n* Patients who are treated with a special diet such as vegetarianism or a special exercise program.\n* Allergy\n* Pregnant and lactating women The participants were allocated randomly to one of the two study groups (Fenobet, Placebo) by a random number table. Then, the eligible people were in one of two groups 1) receiving fenugreek extract (3 capsules of 500 mg, 1 capsule half an hour before meals), 2), receiving placebos (3 capsules of 500 mg, 1 capsule half an hour before meals) and were examined for 8 weeks. It is worth noting that the participants were asked not to change their physical activity and diet during the study and to report any changes in the type and dosage of the drug to the researchers. The capsule and container intended for the placebo will be exactly the same size and color as the fenugreek capsule and a dark container will be chosen for the capsules. At baseline and after two months of intervention, biochemical parameters (fasting blood sugar, HbA1C, lipid profile, C-reactive protein), and anthropometric indices (weight, body mass index, waist circumference, Hip circumference) will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPeople with metabolic syndrome\n\n* Fasting sugar above 100 mg/dL\n* Both men and women\n* Age range 20-60 years\n\nExclusion Criteria:\n\n* Injection of insulin or liraglutide\n* People under 20 years old and over 60 years old\n* having chronic cardiovascular diseases, chronic liver and kidney diseases, uncontrolled thyroid disorders and malignancies including cancer\n* Taking herbal medicines or herbs to control blood sugar and fat in the last 6 months\n* Patients who are treated with a special diet such as vegetarianism or a special exercise program.\n* Allergy\n* Pregnant and lactating women'}, 'identificationModule': {'nctId': 'NCT06114134', 'acronym': 'Fenobet', 'briefTitle': 'The Effects of Fenugreek Extract (Fenobet) on Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'The Effect of Fenobet® Capsules (Fenugreek Seed Extract) on Glycemic Status, Lipid Pattern and Anthropometric Indices in People With Metabolic Syndrome: a Randomized, Double-blind, Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': '97-1151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fenugreek extract', 'description': 'Participants in this group will receive fenugreek extract capsules (500 mg/day, three times a day, 30 minutes before each main meal) along with common treatments', 'interventionNames': ['Dietary Supplement: Fenobet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants in this group will receive starch with added color (similar to the color of fenugreek extract) capsules (with the same size and color of fenugreek) (500 mg/day, three times a day, 30 minutes before each main meal) along with common treatments', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Fenobet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'receiving fenugreek extract (3 capsules of 500 mg, 1 capsule half an hour before meals)', 'armGroupLabels': ['Fenugreek extract']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nazli Namazi', 'investigatorAffiliation': 'Tehran University of Medical Sciences'}}}}