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

Insulin Resistance Clinical Trial

— PBPPCG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03897517
• Other study ID #: 1355505-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 30, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2019
• Source: Plexus Worldwide
• Contact: Lilian de Jonge
• Phone: 7039935153
• Email: edejonge[@]gmu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carbohydrate
• Hyperglycemia
• Insulin Resistance
• Malabsorption
• Malabsorption Syndromes

Intervention

Dietary Supplement:
• Proprietary Botanical Blend
Oral administration of capsules containing proprietary botanical blend 30 minutes prior to carbohydrate ingestion.
• Placebo
Oral administration of capsules containing rice flour (placebo) 30 minutes prior to carbohydrate ingestion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Plexus Worldwide

References & Publications (1)

Augustin LS, Kendall CW, Jenkins DJ, Willett WC, Astrup A, Barclay AW, Björck 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 TM, Baer-Sinnott S, Poli — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Prandial Glycemia	Plasma glucose concentrations after the ingestion of a high carbohydrate meal	3 weeks
Primary	Breathe hydrogen concentration	Measurement of hydrogen in exhaled air as an indicator of carbohydrate absorption	3 weeks

External Links

•   WHO Global Report on Diabetes