Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-31 @ 11:32 PM
Study NCT ID:
NCT05599633
Status:
COMPLETED
Last Update Posted:
2024-12-02
First Post:
2022-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Sago-based Product on Glycaemic and Lipid Control in Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'Intervention (Sago starch) and control (corn starch) will be packed in individual aluminium sachets and will not be distinguishable from each other. The included subjects and investigators will be blinded from the study arm assignment. Randomisation and dispensation of the study starch will be done by the unblinded pharmacists only, who will not be involved in the care of the patients and study endpoint assessments.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-10-26', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of HbA1C value', 'timeFrame': '12 weeks', 'description': 'The change of HbA1C value at 12 weeks of intervention from baseline'}, {'measure': 'Change of fasting blood glucose (FBG) level', 'timeFrame': '12 weeks', 'description': 'The change of FBG level at 12 weeks of intervention from baseline'}, {'measure': 'Change of homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) value', 'timeFrame': '12 weeks', 'description': 'The change of HOMA of insulin resistant value at 12 weeks of intervention from baseline'}, {'measure': 'Change of triglycerides level', 'timeFrame': '12 weeks', 'description': 'The change of triglycerides level at 12 weeks of intervention from baseline'}, {'measure': 'Change of total cholesterol level', 'timeFrame': '12 weeks', 'description': 'The change of total cholesterol level at 12 weeks of intervention from baseline'}, {'measure': 'Change of low density lipoprotein cholesterol (LDL-C) level', 'timeFrame': '12 weeks', 'description': 'The change of LDL-C level at 12 weeks of intervention from baseline'}, {'measure': 'Change of high density lipoprotein cholesterol (HDL-C) level', 'timeFrame': '12 weeks', 'description': 'The change of HDL-C level at 12 weeks of intervention from baseline'}], 'secondaryOutcomes': [{'measure': 'Change of inflammatory marker levels: high-sensitive c-reactive protein (hs-CRP) level', 'timeFrame': '12 weeks', 'description': 'The change of hs-CRP level at 12 weeks of intervention from baseline'}, {'measure': 'Change of inflammatory marker levels: interleukin 6 (IL-6) level', 'timeFrame': '12 weeks', 'description': 'The change of IL-6 level at 12 weeks of intervention from baseline'}, {'measure': 'Change of inflammatory marker levels: blood ferritin level', 'timeFrame': '12 weeks', 'description': 'The change of blood ferritin level at 12 weeks of intervention from baseline'}, {'measure': 'Change of total daily calorie intake', 'timeFrame': '12 weeks', 'description': 'The change of total daily calorie intake at 12 weeks of intervention from baseline'}, {'measure': 'Change of body weight/body mass index (BMI)', 'timeFrame': '12 weeks', 'description': 'The change of BMI at 12 weeks of intervention from baseline'}, {'measure': 'Change of body fat and visceral fat percentages', 'timeFrame': '12 weeks', 'description': 'The change of body fat and visceral fat percentages at 12 weeks of intervention from baseline'}, {'measure': 'Change of waist-hip ratio from baseline', 'timeFrame': '12 weeks', 'description': 'The change of waist-hip ratio at 12 weeks of intervention from baseline'}, {'measure': 'Change of blood pressure from baseline', 'timeFrame': '12 weeks', 'description': 'The change of systolic and diastolic blood pressure at 12 weeks of intervention from baseline'}, {'measure': 'Change of heart rate from baseline', 'timeFrame': '12 weeks', 'description': 'The change of heart rate at 12 weeks of intervention from baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'resistant starch', 'sago', 'Sarawak', 'glycemic control', 'lipid control'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '40345654', 'type': 'DERIVED', 'citation': 'King TL, Bugam SH, Khoo SY, Tan SH, Yeo JJP, Tan SSN, Chan PY, Liew NK, Chunggat J, Tiong LL, Ibrahim AS, Tan FHS, Tiong XT. Effects of 12 Weeks consumption of sago starch on glycaemic and lipid control in patients with type 2 diabetes: A double-blind, randomised, parallel controlled trial. Clin Nutr ESPEN. 2025 Aug;68:300-308. doi: 10.1016/j.clnesp.2025.05.002. Epub 2025 May 8.'}]}, 'descriptionModule': {'briefSummary': 'This will be a parallel, randomised, double-blind, controlled trial. Upon successful screening, subjects will be randomised to either intervention arm or control arm in a ratio of 1:1. The subjects will consume either a drink containing 25g of Sarawak sago starch (intervention) or 25g of corn starch (control) in approximately 200mL of water, two times a day, before lunch and dinner for 12 weeks, in addition to a standardised dietary counselling for diabetes given by the hospital dietitian at baseline. The study endpoints will be evaluated after 12 weeks of starch consumption.', 'detailedDescription': 'SAGODM trial is a parallel, randomised, double-blind, controlled trial on the effect of consuming sago starch for 12 weeks on glycaemic and lipid control in patients with type 2 diabetes mellitus. Diabetic patients who had HbA1C between 6.5% and 8.5% and had no change in the antidiabetic treatment for the past two months (primary inclusion criteria) were invited to participate in the trial. They were randomised to either the intervention arm or control arm in a ratio of 1:1. The subjects will consume either a drink containing 25g of Sarawak sago starch (intervention) or 25g of corn starch (control) in approximately 200mL of water, two times a day, before lunch and dinner for 12 weeks. They will receive standardised dietary counselling for diabetes given by the hospital dietitian at baseline. They will also be asked to record their dietary intake for three consecutive days every month. Blood samples will be taken at baseline and the last visit (post-12 weeks). The study endpoints will be evaluated after 12 weeks of starch consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 - 70 years old\n2. Individual diagnosed with type 2 diabetes for at least three months\n3. Not on any antidiabetic medications or on lifestyle modification or taking a stable dose of oral hypoglycaemic agents, with no change of dose and regime for the past eight weeks\n4. Has HbA1C values of 6.5 - 8.5% within 28 days before commencing the study\n5. Able to complete the clinical study, and\n6. Able to provide written informed consent\n\nExclusion Criteria:\n\n1. History of allergy to sago starch or corn starch\n2. History of allergy to any other ingredients in the study foods\n3. Clinically significant, active and acute cardiovascular disease\n4. Clinically significant, stage 4 - 5 (estimated glomerular filtration rate \\<30mL/min/1.73m2), chronic kidney failure\n5. Clinically significant chronic liver disease or infection\n6. Any malignancies\n7. Regular use of hormone medications, anti-inflammatory medication, steroids, or other medications that might interfere with outcome measure\n8. On a prescribed therapeutic diet\n9. Taking part in weight loss programme\n10. Clinically significant abnormal laboratory investigations\n11. Other medical conditions or reasons, in the opinion of the Investigator or Research Physician, that make one unsuitable to join the study\n12. Concurrent participation in other clinical studies involving intervention or treatment towards obesity, diabetes or impaired glucose\n13. Pregnant or lactating mothers'}, 'identificationModule': {'nctId': 'NCT05599633', 'acronym': 'SAGODM', 'briefTitle': 'Effect of Sago-based Product on Glycaemic and Lipid Control in Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Sarawak General Hospital'}, 'officialTitle': 'Effect of 12 Weeks Consumption of Sago Based Products in a Malaysian Diet on Glycaemic and Lipid Control in Diabetic Patients: a Double-Blind, Randomised, Parallel Controlled Trial', 'orgStudyIdInfo': {'id': 'CRC003-SAGODM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'Subjects who are randomised to Intervention Arm will be taking a drink containing 25g of Sarawak sago starch in 200mL of plain water. The subjects will take the drink twice daily i.e., within 30 minutes before lunch and dinner. On top of that, they will be counselled on diet recommendations for diabetes by a study dietitian at Visit 1 or baseline.', 'interventionNames': ['Dietary Supplement: Sago starch drink']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Arm', 'description': 'Subjects who are randomised to Control Arm will be taking a drink containing 25g of corn starch in 200mL of water. The subjects will take the starch suspension twice daily i.e., within 30 minutes before lunch and dinner. On top of that, they will be counselled on diet recommendation for diabetes by a study dietitian at Visit 1 or baseline.', 'interventionNames': ['Dietary Supplement: Corn starch drink']}], 'interventions': [{'name': 'Sago starch drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Sarawak sago starch drink will be provided by CRAUN throughout the study. The starch drink will be supplied in sealed aluminium sachets. Each sachet contains 25g of study starch with cocoa flavouring.', 'armGroupLabels': ['Intervention Arm']}, {'name': 'Corn starch drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Corn starch drink will be provided by CRAUN throughout the study. The starch drink will be supplied in sealed aluminium sachets. Each sachet contains 25g of study starch with cocoa flavouring.', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93250', 'city': 'Kuching', 'state': 'Sarawak', 'country': 'Malaysia', 'facility': 'Klinik Kesihatan Batu Kawah', 'geoPoint': {'lat': 1.55, 'lon': 110.33333}}, {'zip': '93400', 'city': 'Kuching', 'state': 'Sarawak', 'country': 'Malaysia', 'facility': 'Klinik Kesihatan Jalan Masjid', 'geoPoint': {'lat': 1.55, 'lon': 110.33333}}, {'zip': '93400', 'city': 'Kuching', 'state': 'Sarawak', 'country': 'Malaysia', 'facility': 'Klinik Kesihatan Tanah Puteh', 'geoPoint': {'lat': 1.55, 'lon': 110.33333}}, {'zip': '93586', 'city': 'Kuching', 'state': 'Sarawak', 'country': 'Malaysia', 'facility': 'Sarawak General Hospital', 'geoPoint': {'lat': 1.55, 'lon': 110.33333}}], 'overallOfficials': [{'name': 'Xun Ting Tiong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Centre Sarawak General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sarawak General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'CRAUN Research Sdn. Bhd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Officer', 'investigatorFullName': 'Xun Ting Tiong', 'investigatorAffiliation': 'Sarawak General Hospital'}}}}