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

Not Applicable

• Conditions: Carbohydrate; Insulin Resistance; Malabsorption; Hyperglycemia
• Interventions: Dietary Supplement: Proprietary Botanical Blend; Dietary Supplement: Placebo

• Registration Number: NCT03897517
• Lead Sponsor: Plexus Worldwide

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.

Study Timeline

• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-29
• Study First Posted: 2019-04-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28
• Study Start: 2019-08-30
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Proprietary Botanical Blend	Proprietary Botanical Blend	Proprietary Botanical Blend - Dietary supplement with alpha amylase and sucrase inhibitory activity. 2 capsules
Placebo	Placebo	Non/minimally nutritive nonactive material: rice flour. 2 capsules

Primary Outcome Measures

Name	Time	Method
Post Prandial Glycemia	3 weeks	Plasma glucose concentrations after the ingestion of a high carbohydrate meal
Breathe hydrogen concentration	3 weeks	Measurement of hydrogen in exhaled air as an indicator of carbohydrate absorption