Effect of Proprietary Botanical Blend on Glycemic Control and Post-prandial Carbohydrate Absorption

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Proprietary Botanical Blend on Glycemic Control and Post-prandial Carbohydrate Absorption in Overweight, Insulin Resistant Adult Men and Women

Conditions
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Hyperglycemia, Carbohydrate, Insulin Resistance, Malabsorption

Intervention / Treatment
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* Dietary Supplement: Proprietary Botanical Blend
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proprietary Botanical Blend<br>Proprietary Botanical Blend - Dietary supplement with alpha amylase and sucrase inhibitory activity. 2 capsules | Dietary Supplement: Proprietary Botanical Blend<br>* Oral administration of capsules containing proprietary botanical blend 30 minutes prior to carbohydrate ingestion.<br>|
| Placebo Comparator: Placebo<br>Non/minimally nutritive nonactive material: rice flour. 2 capsules | Dietary Supplement: Placebo<br>* Oral administration of capsules containing rice flour (placebo) 30 minutes prior to carbohydrate ingestion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Prandial Glycemia | Plasma glucose concentrations after the ingestion of a high carbohydrate meal | 3 weeks | 
| Breathe hydrogen concentration | Measurement of hydrogen in exhaled air as an indicator of carbohydrate absorption | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemia, Carbohydrate blocker