Clinical trial NCT06509204: Real-world Evaluation of JBA GlucoTrojan With Reducose® on Glycemic Response
Official title: Real-world Evaluation of JBA GlucoTrojan With Reducose® on Glycemic Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Habits
Lead sponsor: Tastermonial Inc
Sponsor class: INDUSTRY
Collaborators: name: WCG clinical
name: Affordable Quality Pharmaceuticals
First posted: 2024-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: iAUC Calculation
timeFrame: 2-hour period after eating
Secondary outcomes:
Other outcomes:
Locations:
city: Cupertino
country: United States
facility: Tastermonial
state: California
Study officials:
References:
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citation: Zhou J, Li H, Ran X, Yang W, Li Q, Peng Y, Li Y, Gao X, Luan X, Wang W, Jia W. Reference values for continuous glucose monitoring in Chinese subjects. Diabetes Care. 2009 Jul;32(7):1188-93. doi: 10.2337/dc09-0076. Epub 2009 Apr 23.
citation: Shah VN, DuBose SN, Li Z, Beck RW, Peters AL, Weinstock RS, Kruger D, Tansey M, Sparling D, Woerner S, Vendrame F, Bergenstal R, Tamborlane WV, Watson SE, Sherr J. Continuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4356-4364. doi: 10.1210/jc.2018-02763.
citation: Rodriguez-Segade S, Rodriguez J, Camina F, Fernandez-Arean M, Garcia-Ciudad V, Pazos-Couselo M, Garcia-Lopez JM, Alonso-Sampedro M, Gonzalez-Quintela A, Gude F. Continuous glucose monitoring is more sensitive than HbA1c and fasting glucose in detecting dysglycaemia in a Spanish population without diabetes. Diabetes Res Clin Pract. 2018 Aug;142:100-109. doi: 10.1016/j.diabres.2018.05.026. Epub 2018 May 26.
citation: Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Fox LA, Beck RW, Xing D. Variation of interstitial glucose measurements assessed by continuous glucose monitors in healthy, nondiabetic individuals. Diabetes Care. 2010 Jun;33(6):1297-9. doi: 10.2337/dc09-1971. Epub 2010 Mar 9.