Dietary Supplement Clinical Trial
— StardustOfficial title:
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
NCT number | NCT04877366 |
Other study ID # | 2019CLI |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 21, 2021 |
Est. completion date | December 1, 2021 |
Verified date | January 2022 |
Source | Nestlé |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 1, 2021 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - Willing and able to sign written informed consent prior to study entry. - Participants who self-identify as Asian; male or female, >18 years of age. - Established diagnosis of type 2 diabetes (documented by either HbA1c 6.5 - 10.0% or a documented diagnosis of type 2 diabetes). - 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. - Participants must have a hematocrit value greater than or equal to 34.0% for females and 40% for males. - Participants must have a hemoglobin value greater than or equal to 11.0 g/dL for females and 13.5 g/dL for males. Exclusion Criteria: - Fasting plasma glucose >220 mg/dl at screening. - Impaired kidney function, eGFR of <60 mL/min/1.73 m2 at screening. - BMI >35 kg/m2. - Weight = 50 kg. - Elevated liver transaminase > 3 ULN at screening. - Ongoing or recent (i.e. < 3 month) treatment with any oral or injectable glucose-lowering drug other than metformin. - Ongoing or recent (i.e. < 3 month) injectable insulin therapy. - 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. - 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. - Major medical/surgical event requiring hospitalization in the last 3 months. - Known allergy and intolerance to product components or paracetamol. - 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. - Are unable to comply with protocol procedures in the opinion of the investigator. - Have a hierarchical link with the research team members. - Positive pregnancy test or breast-feeding at screening. - 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. - 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. |
Country | Name | City | State |
---|---|---|---|
Singapore | Temasek Polytechnic | Singapore | |
United States | Orange County Research Center | Tustin | California |
Lead Sponsor | Collaborator |
---|---|
Nestlé |
United States, Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Plasma glucose timepoints (ARMs A and B) | Plasma glucose at individual timepoints | 0 ,15, 30, 60, 120, and 180 minutes. | |
Other | Serum insulin timepoints (ARMs A and B) | Serum insulin at individual timepoints | 0 ,15, 30, 60, 120, and 180 minutes. | |
Other | Plasma GIP and GLP-1 (ARMs A and B) | Plasma GIP and GLP-1 at individual timepoints | 0 ,15, 30, 60, 120, and 180 minutes. | |
Other | Plasma IL-6 (ARMs A and B) | Plasma IL-6 at individual timepoints | 0 ,15, 30, 60, 120, and 180 minutes. | |
Other | Plasma GLP-1 iAUC (ARMs A and B) | Plasma GLP-1 (iAUC 0-1h, tAUC 0-1h) | 0 ,15, 30, 60, 120, and 180 minutes. | |
Other | Plasma GIP iAUC (ARMs A and B) | Plasma GIP (iAUC 0-1h, tAUC 0-1h) | 0 ,15, 30, 60, 120, and 180 minutes. | |
Other | Plasma IL-6 iAUC (ARMs A and B) | Plasma IL-6 (iAUC 0-4h, tAUC 0-4h, iAUC 0-2h, tAUC 0-2h, iAUC 0-1h, tAUC 0-1h) | 0 ,15, 30, 60, 120, and 180 minutes. | |
Primary | Post-prandial glycemic excursion (ARMs A and B) | Incremental area under the curve post-prandial glycemic excursion (iAUC 0-1h, iAUC 0-2h, iAUC 0-3h). | 0 ,15, 30, 60, 120, and 180 minutes. | |
Secondary | 2h post-prandial glucose levels (ARMs A and B) | Incremental area under the curve 2h post-prandial glucose levels | 0 ,15, 30, 60, and 120 minutes. | |
Secondary | Total glucose (All ARMS) | Total glucose AUC 0-1h (tAUC 0-1h, tAUC 0-2h, tAUC 0-3h) | 0 ,15, 30, 60, 120, and 180 minutes. | |
Secondary | Plasma glucose iCmax (ARMs A and B) | Plasma glucose iCmax | 0 ,15, 30, 60, 120, and 180 minutes. | |
Secondary | Plasma glucose Tmax (ARMs A and B) | Plasma glucose Tmax | 0 ,15, 30, 60, 120, and 180 minutes. | |
Secondary | Plasma glucose AUC (ARMs A and B) | protocol states (iAUC 0-3h, tAUC 0-3h) | 0 ,15, 30, 60, 120, and 180 minutes. | |
Secondary | Serum insulin (All ARMs) | Serum insulin (iAUC 0-3h, iCmax, Tmax, tAUC 0-3h) | 0 ,15, 30, 60, 120, and 180 minutes. | |
Secondary | Plasma GLP-1 (ARMs A and B) | Plasma GLP-1 (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h) | 0 ,15, 30, 60, 120, and 180 minutes. | |
Secondary | Plasma GIP (ARMs A and B) | Plasma GIP (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h) | 0 ,15, 30, 60, 120, and 180 minutes. | |
Secondary | Plasma interleukin-6 (ARMs A and B) | Plasma interleukin-6 (IL-6) (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h) | 0 ,15, 30, 60, 120, and 180 minutes. | |
Secondary | Gastric emptying (ARMs A and B) | Gastric emptying (iAUC 0-1h, tAUC 0-1h, iAUC 0-3h, tAUC 0-3h, Cmax and Tmax for paracetamol) | 0 ,15, 30, 60, 120, and 180 minutes. | |
Secondary | Matsuda Index (ARMs A and B) | Matsuda Index | 0, 30, 60, and 120 minutes. |
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