Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-21 @ 11:17 PM
Study NCT ID:
NCT03625856
Status:
COMPLETED
Last Update Posted:
2020-01-03
First Post:
2018-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Chlorella Supplementation on Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'This study is a double-blind, randomized controlled trial. Subjects will be randomly allocated into two groups and each one will receive the supplement (Chlorella Vulgaris) or placebo for 8 weeks. To prevent selection bias, the study participants, investigators and the laboratory staff will be all blinded to treatment assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomly allocated into two groups; Chlorella and placebo groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-02', 'studyFirstSubmitDate': '2018-08-08', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c changes', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'Serum HbA1c concentration'}], 'secondaryOutcomes': [{'measure': 'FBS changes', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'Serum glucose concentration'}, {'measure': 'Insulin sensitivity changes', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'HOMA-IR'}, {'measure': 'Triglyceride changes', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'Serum TG concentration'}, {'measure': 'Total cholesterol changes', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'Serum TC concentration'}, {'measure': 'HDL-Cholesterol changes', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'Serum HDL concentration'}, {'measure': 'Weight change', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'Body weight of participants'}, {'measure': 'Systolic blood pressure changes', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'Systolic blood pressure'}, {'measure': 'Diastolic blood pressure changes', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'Diastolic blood pressure'}, {'measure': 'Anxiety score changes', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'The beck anxiety inventory (BAI) is used for the evaluations. The total range of this 21 item questionnaire is from zero to 63. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). These points are summed and the total score of 0-7 for sub-scales is considered nonexistence or the least form of anxiety,8-15 slight,16-25 moderate and 26-63 indicate the severe form of it.'}, {'measure': 'Depression score changes', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'The beck depression inventory (BDI) is used for the evaluations. The total range of this 21 item questionnaire is from zero to 40. BDI items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. These points are summed and the total score of 0-10 for sub-scales is considered normal,11-16 Mild mood disturbance,17-20 borderline clinical depression, 21-30 moderate depression, 31-40 severe depression and over 40 is considered extreme depression.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Diabetes is a chronic disease and the prevalence of diabetes mellitus is rapidly increasing as a result of population ageing, urbanization and associated lifestyle changes. Recently, the use of natural products in chronic diseases such as diabetes has gained more attention. Chlorella is a single-celled green algae that contains essential nutrients including amino acids and fatty acids as well as some vitamins and minerals. There have been some studies on the effects of chlorella supplementation in chronic diseases such as NAFLD, prediabetes and diabetic mice, but none of them examined the effects of chlorella in patients with type 2 diabetes. Thus the present study designed to evaluate the effects of chlorella supplementation on glycemic control, lipid profile and anthropometric measurements in type 2 diabetic patients.', 'detailedDescription': 'This study is a double-blind, randomized controlled trial. 84 patients with type 2 diabetes are recruited. After informing the patients about this study and filling the consent letters, they are randomly assigned into intervention group (n=42) or placebo group (n=42) receiving 1500 mg chlorella Vulgaris or placebo daily for 8 weeks. Patients are asked not to change their regular physical activity, diet, medicine and dosage during the study. Anthropometric and blood pressure measurements are collected and 24-hour food intake recall, IPAQ physical activity, Pittsburgh Sleep Quality Assessment (PSQI) and Beck anxiety and depression questionnaires are filled by each patients at the beginning and end of the study. In addition, blood samples are collected at the beginning and end of the study to determine the changes of FBS, HbA1c, insulin concentration and insulin resistance (HOMA-IR) and lipid profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tendency to participate\n* Clinical diagnosis of T2DM\n* Having T2DM for at least 1 year\n* Range of HbA1c between 6.5% and 8.5%\n* Triglyceride range lower than 300 mg/dl\n\nExclusion Criteria:\n\n* Insulin dependent patients\n* Smoking and alcohol consumption\n* Patients with cardiovascular disease, liver disease, renal and thyroid diseases\n* Pregnancy, lactation and menopause\n* Intake of multivitamin and mineral supplements'}, 'identificationModule': {'nctId': 'NCT03625856', 'briefTitle': 'The Effect of Chlorella Supplementation on Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Islamic Azad University, Sanandaj'}, 'officialTitle': 'The Effect of Chlorella Vulgaris Supplementation on Glycemic Control, Lipid Profile and Anthropometric Measurements on Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'IR.TUMS.EMRI.REC.1396.00195'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '1500 mg Chlorella Vulgaris capsule', 'interventionNames': ['Dietary Supplement: Chlorella Vulgaris']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': '1500 mg placebo (starch)', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Chlorella Vulgaris', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Algomed'], 'description': 'Chlorella capsules 1500 mg/day', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Starch 1500 mg', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Amir Mahdi Hosseini', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Ali Keshavarz, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Islamic Azad University,Science and Research Branch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Behnood Abbasi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Dr. Behnood Abbasi', 'investigatorAffiliation': 'Islamic Azad University, Sanandaj'}}}}