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

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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Key information

Conditions

Food Habits Behavior Behavior, Animal Feeding Behavior

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tastermonial

Cupertino, California, 95014, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Glucotrojan

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Tastermonial Inc

Industry

Collaborators

Affordable Quality Pharmaceuticals
WCG clinical

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jul 19, 2024
Registry last updated: Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed