Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-26 @ 6:32 PM
Study NCT ID:
NCT04877366
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2021-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate Effects of Sprinkled Format REDUCOSE in a Carbohydrate-rich, Mixed Meal on Post-prandial Glycemia
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', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-11', 'studyFirstSubmitDate': '2021-04-28', 'studyFirstSubmitQcDate': '2021-05-03', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Plasma glucose timepoints (ARMs A and B)', 'timeFrame': '0 ,15, 30, 60, 120, and 180 minutes.', 'description': 'Plasma glucose at individual timepoints'}, {'measure': 'Serum insulin timepoints (ARMs A and B)', 'timeFrame': '0 ,15, 30, 60, 120, and 180 minutes.', 'description': 'Serum insulin at individual timepoints'}, {'measure': 'Plasma GIP and GLP-1 (ARMs A and B)', 'timeFrame': '0 ,15, 30, 60, 120, and 180 minutes.', 'description': 'Plasma GIP and GLP-1 at individual timepoints'}, {'measure': 'Plasma IL-6 (ARMs A and B)', 'timeFrame': '0 ,15, 30, 60, 120, and 180 minutes.', 'description': 'Plasma IL-6 at individual timepoints'}, {'measure': 'Plasma GLP-1 iAUC (ARMs A and B)', 'timeFrame': '0 ,15, 30, 60, 120, and 180 minutes.', 'description': 'Plasma GLP-1 (iAUC 0-1h, tAUC 0-1h)'}, {'measure': 'Plasma GIP iAUC (ARMs A and B)', 'timeFrame': '0 ,15, 30, 60, 120, and 180 minutes.', 'description': 'Plasma GIP (iAUC 0-1h, tAUC 0-1h)'}, {'measure': 'Plasma IL-6 iAUC (ARMs A and B)', 'timeFrame': '0 ,15, 30, 60, 120, and 180 minutes.', 'description': 'Plasma IL-6 (iAUC 0-4h, tAUC 0-4h, iAUC 0-2h, tAUC 0-2h, iAUC 0-1h, tAUC 0-1h)'}], 'primaryOutcomes': [{'measure': 'Post-prandial glycemic excursion (ARMs A and B)', 'timeFrame': '0 ,15, 30, 60, 120, and 180 minutes.', 'description': 'Incremental area under the curve post-prandial glycemic excursion (iAUC 0-1h, iAUC 0-2h, iAUC 0-3h).'}], 'secondaryOutcomes': [{'measure': '2h post-prandial glucose levels (ARMs A and B)', 'timeFrame': '0 ,15, 30, 60, and 120 minutes.', 'description': 'Incremental area under the curve 2h post-prandial glucose levels'}, {'measure': 'Total glucose (All ARMS)', 'timeFrame': '0 ,15, 30, 60, 120, and 180 minutes.', 'description': 'Total glucose AUC 0-1h (tAUC 0-1h, tAUC 0-2h, tAUC 0-3h)'}, {'measure': 'Plasma glucose iCmax (ARMs A and B)', 'timeFrame': '0 ,15, 30, 60, 120, and 180 minutes.', 'description': 'Plasma glucose iCmax'}, {'measure': 'Plasma glucose Tmax (ARMs A and B)', 'timeFrame': '0 ,15, 30, 60, 120, and 180 minutes.', 'description': 'Plasma glucose Tmax'}, {'measure': 'Plasma glucose AUC (ARMs A and B)', 'timeFrame': '0 ,15, 30, 60, 120, and 180 minutes.', 'description': 'protocol states (iAUC 0-3h, tAUC 0-3h)'}, {'measure': 'Serum insulin (All ARMs)', 'timeFrame': '0 ,15, 30, 60, 120, and 180 minutes.', 'description': 'Serum insulin (iAUC 0-3h, iCmax, Tmax, tAUC 0-3h)'}, {'measure': 'Plasma GLP-1 (ARMs A and B)', 'timeFrame': '0 ,15, 30, 60, 120, and 180 minutes.', 'description': 'Plasma GLP-1 (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)'}, {'measure': 'Plasma GIP (ARMs A and B)', 'timeFrame': '0 ,15, 30, 60, 120, and 180 minutes.', 'description': 'Plasma GIP (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)'}, {'measure': 'Plasma interleukin-6 (ARMs A and B)', 'timeFrame': '0 ,15, 30, 60, 120, and 180 minutes.', 'description': 'Plasma interleukin-6 (IL-6) (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)'}, {'measure': 'Gastric emptying (ARMs A and B)', 'timeFrame': '0 ,15, 30, 60, 120, and 180 minutes.', 'description': 'Gastric emptying (iAUC 0-1h, tAUC 0-1h, iAUC 0-3h, tAUC 0-3h, Cmax and Tmax for paracetamol)'}, {'measure': 'Matsuda Index (ARMs A and B)', 'timeFrame': '0, 30, 60, and 120 minutes.', 'description': 'Matsuda Index'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dietary Supplement']}, 'referencesModule': {'references': [{'pmid': '36855010', 'type': 'DERIVED', 'citation': 'Mohamed M, Zagury RL, Bhaskaran K, Neutel J, Mohd Yusof BN, Mooney L, Yeo L, Kirwan BA, Aprikian O, von Eynatten M, Johansen OE. A Randomized, Placebo-Controlled Crossover Study to Evaluate Postprandial Glucometabolic Effects of Mulberry Leaf Extract, Vitamin D, Chromium, and Fiber in People with Type 2 Diabetes. Diabetes Ther. 2023 Apr;14(4):749-766. doi: 10.1007/s13300-023-01379-4. Epub 2023 Mar 1.'}]}, 'descriptionModule': {'briefSummary': 'This is a mechanistic, single-center, double-blind, placebo- and active-controlled, three-time-period, crossover study to evaluate the effect of sprinkled format REDUCOSE compared to placebo (double-blind; confirmative) and active control (open-label; acarbose - explorative) on post prandial glycemia in Asian patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to sign written informed consent prior to study entry.\n* Participants who self-identify as Asian; male or female, \\>18 years of age.\n* Established diagnosis of type 2 diabetes (documented by either HbA1c 6.5 - 10.0% or a documented diagnosis of type 2 diabetes).\n* Treatment naïve or on active therapy with metformin at a daily dose of 500-3000 mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.\n* Participants must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.\n* Participants must have a hemoglobin value greater than or equal to 11.0 g/dL for females and 13.5 g/dL for males.\n\nExclusion Criteria:\n\n* Fasting plasma glucose \\>220 mg/dl at screening.\n* Impaired kidney function, eGFR of \\<60 mL/min/1.73 m2 at screening.\n* BMI \\>35 kg/m2.\n* Weight ≤ 50 kg.\n* Elevated liver transaminase \\> 3 ULN at screening.\n* Ongoing or recent (i.e. \\< 3 month) treatment with any oral or injectable glucose-lowering drug other than metformin.\n* Ongoing or recent (i.e. \\< 3 month) injectable insulin therapy.\n* Ongoing or recent (i.e. \\< 3 month) weight loss interventions (e.g. dietary weight loss programs) or any history of bariatric surgery or any documented weight loss \\>5% within previous 6 months.\n* Ongoing or recent (i.e. \\< 3 month) treatment with anorectic drugs, systemic steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption.\n* Major medical/surgical event requiring hospitalization in the last 3 months.\n* Known allergy and intolerance to product components or paracetamol.\n* Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.\n* Are unable to comply with protocol procedures in the opinion of the investigator.\n* Have a hierarchical link with the research team members.\n* Positive pregnancy test or breast-feeding at screening.\n* Participants who have been dosed in another clinical study with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening.\n* Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Participants must also agree to not donate blood within 8 weeks after their last visit.'}, 'identificationModule': {'nctId': 'NCT04877366', 'acronym': 'Stardust', 'briefTitle': 'Evaluate Effects of Sprinkled Format REDUCOSE in a Carbohydrate-rich, Mixed Meal on Post-prandial Glycemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'A Randomized, Double-blind, Placebo- and Active-Controlled, Single-Center, Three-time-period, Crossover Study to Evaluate the Effects of Sprinkled Format REDUCOSE on Post-Prandial Glycemic Response in Asian Patients with Type 2 Diabetes', 'orgStudyIdInfo': {'id': '2019CLI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ARM A: Sprinkled Format REDUCOSE', 'description': '2 G powder sprinkle containing 250 mg REDUCOSE (mulberry leaf extract - 250 mg - 5% DNJ) + fiber, vitamin D, and chromium picolinate', 'interventionNames': ['Dietary Supplement: Dietary Supplement: Sprinkled Format REDUCOSE.']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ARM B: Placebo B: Standard Meal', 'description': 'A placebo matching to the test product will be used as control', 'interventionNames': ['Other: Reference control']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ARM C: Placebo C: Acarbose', 'description': 'Acarbose 100 mg tablet (provided in open-label format)', 'interventionNames': ['Other: Active comparator']}], 'interventions': [{'name': 'Dietary Supplement: Sprinkled Format REDUCOSE.', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 G powder sprinkle containing 250 mg REDUCOSE (mulberry leaf extract - 250 mg - 5% DNJ) + fiber, vitamin D, and chromium picolinate', 'armGroupLabels': ['ARM A: Sprinkled Format REDUCOSE']}, {'name': 'Reference control', 'type': 'OTHER', 'description': 'A placebo matching to the test product will be used as control', 'armGroupLabels': ['ARM B: Placebo B: Standard Meal']}, {'name': 'Active comparator', 'type': 'OTHER', 'description': 'Acarbose 100 mg tablet (provided in open-label format)', 'armGroupLabels': ['ARM C: Placebo C: Acarbose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Research Center', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '529757', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Temasek Polytechnic', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}