Dietary SupplementStardustNCT04877366
Evaluate Effects of Sprinkled Format REDUCOSE in a Carbohydrate-rich, Mixed Meal on Post-prandial Glycemia
A study testing Dietary Supplement: Sprinkled Format REDUCOSE. and Active comparator in people with Dietary Supplement, run by Société des Produits Nestlé (SPN) at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplement
- What is being tested?
- Dietary Supplement: Sprinkled Format REDUCOSE. and Active comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Jul 2021to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Orange County Research Center
Tustin, California, 92780
About this study
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
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.
- Conditions
- Dietary Supplement
- Being tested
- Dietary Supplement: Sprinkled Format REDUCOSE., Reference control, Active comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: Sprinkled Format REDUCOSE.Dietary supplement
2 G powder sprinkle containing 250 mg REDUCOSE (mulberry leaf extract - 250 mg - 5% DNJ) + fiber, vitamin D, and chromium picolinate
Reference controlOther
A placebo matching to the test product will be used as control
Active comparatorOther
Acarbose 100 mg tablet (provided in open-label format)
| Study group | Role | What they receive |
|---|---|---|
| ARM A: Sprinkled Format REDUCOSE | Active comparator | 2 G powder sprinkle containing 250 mg REDUCOSE (mulberry leaf extract - 250 mg - 5% DNJ) + fiber, vitamin D, and chromium picolinate Receives: Dietary Supplement: Dietary Supplement: Sprinkled Format REDUCOSE. |
| ARM B: Placebo B: Standard Meal | Placebo comparator | A placebo matching to the test product will be used as control Receives: Other: Reference control |
| ARM C: Placebo C: Acarbose | Placebo comparator | Acarbose 100 mg tablet (provided in open-label format) Receives: Other: Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 0 ,15, 30, 60, 120, and 180 minutes.
Secondary outcomes (11)
2h post-prandial glucose levels (ARMs A and B)
Incremental area under the curve 2h post-prandial glucose levels
Measured: 0 ,15, 30, 60, and 120 minutes.
Total glucose (All ARMS)
Total glucose AUC 0-1h (tAUC 0-1h, tAUC 0-2h, tAUC 0-3h)
Measured: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma glucose iCmax (ARMs A and B)
Plasma glucose iCmax
Measured: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma glucose Tmax (ARMs A and B)
Plasma glucose Tmax
Measured: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma glucose AUC (ARMs A and B)
protocol states (iAUC 0-3h, tAUC 0-3h)
Measured: 0 ,15, 30, 60, 120, and 180 minutes.
Serum insulin (All ARMs)
Serum insulin (iAUC 0-3h, iCmax, Tmax, tAUC 0-3h)
Measured: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma GLP-1 (ARMs A and B)
Plasma GLP-1 (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)
Measured: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma GIP (ARMs A and B)
Plasma GIP (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)
Measured: 0 ,15, 30, 60, 120, and 180 minutes.
Plasma interleukin-6 (ARMs A and B)
Plasma interleukin-6 (IL-6) (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)
Measured: 0 ,15, 30, 60, 120, and 180 minutes.
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)
Measured: 0 ,15, 30, 60, 120, and 180 minutes.
Matsuda Index (ARMs A and B)
Matsuda Index
Measured: 0, 30, 60, and 120 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start21 Jul 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary SupplementStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877366
- Sponsor's protocol ID
- 2019CLI
- Acronym
- Stardust
- Status last verified
- Oct 2024
- First submitted
- 28 Apr 2021
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36855010
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04877366
- Acronym / sponsor ID
- Stardust / 2019CLI
- Conditions
- Dietary Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARM A: Sprinkled Format REDUCOSE | Active comparator | 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 |
| ARM B: Placebo B: Standard Meal | Placebo comparator | Other: Reference controlA placebo matching to the test product will be used as control |
| ARM C: Placebo C: Acarbose | Placebo comparator | Other: Active comparatorAcarbose 100 mg tablet (provided in open-label format) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | ARM A: Sprinkled Format REDUCOSE |
| Reference controlA placebo matching to the test product will be used as control | Other | ARM B: Placebo B: Standard Meal |
| Active comparatorAcarbose 100 mg tablet (provided in open-label format) | Other | ARM C: Placebo C: Acarbose |
Primary outcome
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).
11 secondary outcomes
2h post-prandial glucose levels (ARMs A and B)
Time frame: 0 ,15, 30, 60, and 120 minutes.
Total glucose (All ARMS)
Time frame: 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 Tmax (ARMs A and B)
Time frame: 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.
Serum insulin (All ARMs)
Time frame: 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 GIP (ARMs A and B)
Time frame: 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.
Gastric emptying (ARMs A and B)
Time frame: 0 ,15, 30, 60, 120, and 180 minutes.
Matsuda Index (ARMs A and B)
Time frame: 0, 30, 60, and 120 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 36855010Mohamed 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement: Sprinkled Format REDUCOSE. and Active comparator in people with Dietary Supplement, run by Société des Produits Nestlé (SPN) at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-prandial glycemic excursion (ARMs A and B) (time frame: 0 ,15, 30, 60, 120, and 180 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04877366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.