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

October 11, 2024 updated by: Société des Produits Nestlé (SPN)

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 529757
        • Temasek Polytechnic
  • United States
    • California
      • Tustin, California, United States, 92780
        • Orange County Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: ARM A: Sprinkled Format REDUCOSE
2 G powder sprinkle containing 250 mg REDUCOSE (mulberry leaf extract - 250 mg - 5% DNJ) + fiber, vitamin D, and chromium picolinate
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
Placebo Comparator: ARM B: Placebo B: Standard Meal
A placebo matching to the test product will be used as control
Other: Reference control
A placebo matching to the test product will be used as control
Placebo Comparator: ARM C: Placebo C: Acarbose
Acarbose 100 mg tablet (provided in open-label format)
Other: Active comparator
Acarbose 100 mg tablet (provided in open-label format)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post-prandial glycemic excursion (ARMs A and B)
Time Frame: 0 ,15, 30, 60, 120, and 180 minutes.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
2h post-prandial glucose levels (ARMs A and B)
Time Frame: 0 ,15, 30, 60, and 120 minutes.
Incremental area under the curve 2h post-prandial glucose levels
0 ,15, 30, 60, and 120 minutes.
Total glucose (All ARMS)
Time Frame: 0 ,15, 30, 60, 120, and 180 minutes.
Total glucose AUC 0-1h (tAUC 0-1h, tAUC 0-2h, tAUC 0-3h)
0 ,15, 30, 60, 120, and 180 minutes.
Plasma glucose iCmax (ARMs A and B)
Time Frame: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma glucose iCmax
0 ,15, 30, 60, 120, and 180 minutes.
Plasma glucose Tmax (ARMs A and B)
Time Frame: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma glucose Tmax
0 ,15, 30, 60, 120, and 180 minutes.
Plasma glucose AUC (ARMs A and B)
Time Frame: 0 ,15, 30, 60, 120, and 180 minutes.
protocol states (iAUC 0-3h, tAUC 0-3h)
0 ,15, 30, 60, 120, and 180 minutes.
Serum insulin (All ARMs)
Time Frame: 0 ,15, 30, 60, 120, and 180 minutes.
Serum insulin (iAUC 0-3h, iCmax, Tmax, tAUC 0-3h)
0 ,15, 30, 60, 120, and 180 minutes.
Plasma GLP-1 (ARMs A and B)
Time Frame: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma GLP-1 (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)
0 ,15, 30, 60, 120, and 180 minutes.
Plasma GIP (ARMs A and B)
Time Frame: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma GIP (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)
0 ,15, 30, 60, 120, and 180 minutes.
Plasma interleukin-6 (ARMs A and B)
Time Frame: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma interleukin-6 (IL-6) (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)
0 ,15, 30, 60, 120, and 180 minutes.
Gastric emptying (ARMs A and B)
Time Frame: 0 ,15, 30, 60, 120, and 180 minutes.
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.
Matsuda Index (ARMs A and B)
Time Frame: 0, 30, 60, and 120 minutes.
Matsuda Index
0, 30, 60, and 120 minutes.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma glucose timepoints (ARMs A and B)
Time Frame: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma glucose at individual timepoints
0 ,15, 30, 60, 120, and 180 minutes.
Serum insulin timepoints (ARMs A and B)
Time Frame: 0 ,15, 30, 60, 120, and 180 minutes.
Serum insulin at individual timepoints
0 ,15, 30, 60, 120, and 180 minutes.
Plasma GIP and GLP-1 (ARMs A and B)
Time Frame: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma GIP and GLP-1 at individual timepoints
0 ,15, 30, 60, 120, and 180 minutes.
Plasma IL-6 (ARMs A and B)
Time Frame: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma IL-6 at individual timepoints
0 ,15, 30, 60, 120, and 180 minutes.
Plasma GLP-1 iAUC (ARMs A and B)
Time Frame: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma GLP-1 (iAUC 0-1h, tAUC 0-1h)
0 ,15, 30, 60, 120, and 180 minutes.
Plasma GIP iAUC (ARMs A and B)
Time Frame: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma GIP (iAUC 0-1h, tAUC 0-1h)
0 ,15, 30, 60, 120, and 180 minutes.
Plasma IL-6 iAUC (ARMs A and B)
Time Frame: 0 ,15, 30, 60, 120, and 180 minutes.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Société des Produits Nestlé (SPN)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019CLI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Dietary Supplements

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