NCT03897517

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Plexus Worldwide · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperglycemia
• Carbohydrate
• Insulin Resistance
• Malabsorption

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Proprietary Botanical Blend	Oral administration of capsules containing proprietary botanical blend 30 minutes prior to carbohydrate ingestion.
DIETARY_SUPPLEMENT	Placebo	Oral administration of capsules containing rice flour (placebo) 30 minutes prior to carbohydrate ingestion.

Timeline

• Start date: 2019-08-30
• Primary completion: 2019-11-30
• Completion: 2019-12-31
• First posted: 2019-04-01
• Last updated: 2019-08-28