Evaluate Effects of Sprinkled Format REDUCOSE in a Carbohydrate-rich, Mixed Meal on Post-prandial Glycemia

Dietary Supplement Clinical Trial

— Stardust  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04877366
• Other study ID #: 2019CLI
• Status: Completed
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2022
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Dietary Supplement

Intervention

Dietary Supplement:
• Dietary Supplement: Sprinkled Format REDUCOSE.
2 G powder sprinkle containing 250 mg REDUCOSE (mulberry leaf extract - 250 mg - 5% DNJ) + fiber, vitamin D, and chromium picolinate

Other:
• Reference control
A placebo matching to the test product will be used as control
• Active comparator
Acarbose 100 mg tablet (provided in open-label format)

Locations

Country	Name	City	State
Singapore	Temasek Polytechnic	Singapore
United States	Orange County Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Countries where clinical trial is conducted

United States,  Singapore, 

Outcome

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.