Clinical trial NCT03897517: Effect of Proprietary Botanical Blend on Glycemic Control and Post-prandial Carbohydrate Absorption
Official title: Effect of Proprietary Botanical Blend on Glycemic Control and Post-prandial Carbohydrate Absorption in Overweight, Insulin Resistant Adult Men and Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperglycemia
Carbohydrate
Insulin Resistance
Malabsorption
Keywords: Glycemia
Carbohydrate blocker
Lead sponsor: Plexus Worldwide
Sponsor class: INDUSTRY
First posted: 2019-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will receive both treatments in random order with a washout period of at least 1 week between the 2 study visits. Women will be measured during the follicular phase of the menstrual cycle.
Primary purpose: PREVENTION

Brief summary: This project will test a unique botanical formula designed to inhibit alpha amylase (the primary starch degrading digestive enzyme) and inhibit sucrase (the primary sucrose degrading digestive enzyme) in order to reduce acute post prandial glycemia regardless of nutritive carbohydrate source.

Detailed description: Type 2 diabetes is a metabolic disorder characterized by elevated fasting blood glucose and impaired insulin signaling (insulin resistance) and is associated with several comorbidities including neuropathy, retinopathy, kidney disease, and elevated risk for heart attack and stroke. Lifestyle interventions targeted towards prevention of type 2 diabetes include: maintaining and achieving healthy bodyweight, physical activity, avoiding tobacco use, and reducing sugar and saturated fat intake. The International Scientific Consensus Summit from the International Carbohydrate Quality Consortium indicated that diets low in glycemic index and glycemic load were important in the prevention and management of diabetes. Health supplements that can lower the glycemic index and glycemic load of food have potential to support the prevention of diabetes and improve blood glucose management by reducing post prandial glycemia and insulinemia. This project will test a unique botanical formula designed to inhibit alpha amylase (the primary starch degrading digestive enzyme) and inhibit sucrase (the primary sucrose degrading digestive enzyme) in order to reduce acute post prandial glycemia regardless of nutritive carbohydrate source. This proposal will fill a void in the literature by testing for the first time the effect of a combination of mulberry leaf, white kidney bean extract and cinnamon on postprandial carbohydrate absorption and glucose control in overweight, insulin resistant men and women. This project will provide pilot data to support larger studies, and studies to investigate long-term effects.

Eligibility criteria: Inclusion Criteria:

* Ages 18-65 years
* Men and women
* Able to provide written consent in English
* A body mass index between 23.0 and 30.0 kg/m2
* A fasting serum blood glucose level between 100.0 and 126.0 mg/dL

Exclusion Criteria:

* Current smoker
* Having a BMI less than 23.0 kg/m2 and higher than 30.0 kg/m2
* Having a fasting blood glucose level less than 100.0 mg/dL and higher than 126.0 mg/dL
* Suffering from known serious cardiac, hepatic, renal, pulmonary, gastrointestinal, endocrine or hematological disease based on investigator determination, aside from pre-diabetes
* Currently pregnant or breastfeeding
* Consuming more than 2 alcoholic drinks per day on average.
* Weight loss of more than 5% of body weight over the past 6 months

Primary outcomes:
measure: Post Prandial Glycemia
timeFrame: 3 weeks
measure: Breathe hydrogen concentration
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Augustin LSA, Kendall CWC, Jenkins DJA, Willett WC, Astrup A, Barclay AW, Bjorck I, Brand-Miller JC, Brighenti F, Buyken AE, Ceriello A, La Vecchia C, Livesey G, Liu S, Riccardi G, Rizkalla SW, Sievenpiper JL, Trichopoulou A, Wolever TMS, Baer-Sinnott S, Poli A. Glycemic index, glycemic load and glycemic response: An International Scientific Consensus Summit from the International Carbohydrate Quality Consortium (ICQC). Nutr Metab Cardiovasc Dis. 2015 Sep;25(9):795-815. doi: 10.1016/j.numecd.2015.05.005. Epub 2015 May 16.