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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-04

Study Completion Date

2023-06-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Food Habits

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Glucotrojan

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes