Real-world Evaluation of JBA GlucoTrojan With Reducose® on Glycemic Response

July 16, 2024 updated by: Tastermonial Inc
The project is focused on evaluating the real-world efficacy of JBA GlucoTrojan, a powdered supplement sachet containing Reducose, a natural water extract of White Mulberry Leaf, which has been scientifically proven to reduce the absorption of sugars and carbs by up to 40%. The study aims to compare the effect of consuming GlucoTrojan with a meal (Test Meal) vs. having the meal alone (control) on the blood sugar response of 50 healthy adults, pre-diabetes, or non-insulin dependent diabetes, over a period of 14 days. It is expected that GlucoTrojan will reduce the incremental area under the curve and the peak for plasma glucose concentration over 120 minutes in normoglycemic adults when compared to the response to a control meal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • 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

  • United States
    • California
      • Cupertino, California, United States, 95014
        • Tastermonial

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • Consent to study protocol
  • BMI: 18.5 to 29.9 kg/m2
  • 21 to 75 years old

Exclusion criteria:

  • Physician-diagnosed T1D and insulin-dependent T2D
  • Taking medications that modulate blood glucose response or control blood pressure other than Metformin
  • An underlying health condition that warrants non-participation
  • Individuals who are pregnant
  • Any other dietary restrictions that prevent them from consuming study foods
  • Unable to follow remote guidance via the Internet or smartphone
  • Unable to follow controlled diet instructions
  • Unable to use a CGM (Continuous Glucose Monitoring Devices)

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Consumer

AQP Pharmaceuticals, Inc. ("Company") developed a powdered supplement sachet that can be added to meals targeting consumers who follow carbohydrate-heavy Asian diets. The product is formulated with the patented ingredient, "Reducose®", a natural water extract of novel White Mulberry Leaf that has been scientifically proven to reduce the absorption of sugars and other carbs by up to 40%. The effects have been confirmed previously via Randomized, Double-Blind, Controlled Trials.

The Company is looking to conduct a real-world study of blood glucose responses to JBA GlucoTrojan (see specifications here) with a 5% concentration of Reducose®. The study will observe the real-world efficacy of GlucoTrojan when taken with high carbohydrate meals.
Dietary supplement: Glucotrojan

Day 1: Start wearing the CGM sensor and let it self-calibrate for 24 h Day 2: Consume 1 serving of Test Meal for breakfast. Log the meal in the app. Day 3: Consume 1 serving of Test Meal with GlucoTrojan for breakfast. Log the meal in the app.

Days 4-8: Participants will be instructed to take GlucoTrojan twice per day. Once during their typical breakfast meal and once during their typical dinner meal. Each breakfast and dinner will be logged in the app.

Days 9-13: Participants will continue with their typical lives but continue to log meals - breakfast and dinner - in the app.

Day 14: end

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iAUC Calculation
Time Frame: 2-hour period after eating
Each participant's eating period (called a "meal") is normalized and overlaid in a data frame that captures glucose values over the course of the test. Several other metrics are computed, such as maximum and minimum values, standard deviation, and others. In particular, the iAUC ("incremental area under the curve"), a measure of the total amount of postprandial blood glucose level increased over the entire 2-hour period after eating. The methodology of iAUC calculation follows the gold standard used in the measurement of the glycemic index (1, 2). The iAUC metric allows our team to easily compare and rank testing results, as well as compare against the pure sugar responses or the sugar tolerance test of an individual.
2-hour period after eating

Collaborators and Investigators

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

Sponsor

Tastermonial Inc

Collaborators

WCG clinical
Affordable Quality Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 4, 2023

Primary Completion (Actual)

June 4, 2023

Study Completion (Actual)

June 4, 2023

Study Registration Dates

First Submitted

June 28, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 19, 2024

Last Update Submitted That Met QC Criteria

July 16, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 1351713

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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