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

NCT04877366 | Completed

• 1 other identifier: 2019CLI
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Dietary Supplement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 2h post-prandial glucose levels (ARMs A and B)

  0 ,15, 30, 60, and 120 minutes.

• Total glucose (All ARMS)

  0 ,15, 30, 60, 120, and 180 minutes.

• Plasma glucose iCmax (ARMs A and B)

  0 ,15, 30, 60, 120, and 180 minutes.

• Plasma glucose Tmax (ARMs A and B)

  0 ,15, 30, 60, 120, and 180 minutes.

• Plasma glucose AUC (ARMs A and B)

  0 ,15, 30, 60, 120, and 180 minutes.

Other Outcomes (7)

• Plasma glucose timepoints (ARMs A and B)

  0 ,15, 30, 60, 120, and 180 minutes.

• Serum insulin timepoints (ARMs A and B)

  0 ,15, 30, 60, 120, and 180 minutes.

• Plasma GIP and GLP-1 (ARMs A and B)

  0 ,15, 30, 60, 120, and 180 minutes.

Study Arms (3)

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

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

Other: Reference control

ARM C: Placebo C: Acarbose

PLACEBO COMPARATOR

Acarbose 100 mg tablet (provided in open-label format)

Other: Active comparator

Interventions

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

ARM A: Sprinkled Format REDUCOSE

Reference control OTHER

A placebo matching to the test product will be used as control

ARM B: Placebo B: Standard Meal

Active comparator OTHER

Acarbose 100 mg tablet (provided in open-label format)

ARM C: Placebo C: Acarbose

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (2)

Orange County Research Center

Tustin, California, 92780, United States

Location

Temasek Polytechnic

Singapore, 529757, Singapore

Location

Related Publications (1)

• 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.

  PMID: 36855010 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 7, 2021
• Study Start: July 21, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); US (1)