Food Habits
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTGlucotrojan
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
Sponsors
WCG clinical
Affordable Quality Pharmaceuticals
Tastermonial Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| iAUC Calculation | 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. |
Countries
United States
Outcome results
None listed