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

NCT ID: NCT03897517

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-30
• Study Completion Date: 2019-12-31

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.

Conditions

Hyperglycemia; Carbohydrate; Insulin Resistance; Malabsorption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Proprietary Botanical Blend

Proprietary Botanical Blend - Dietary supplement with alpha amylase and sucrase inhibitory activity. 2 capsules

Group Type: EXPERIMENTAL

Proprietary Botanical Blend

Intervention Type: DIETARY_SUPPLEMENT

Oral administration of capsules containing proprietary botanical blend 30 minutes prior to carbohydrate ingestion.

Placebo

Non/minimally nutritive nonactive material: rice flour. 2 capsules

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Oral administration of capsules containing rice flour (placebo) 30 minutes prior to carbohydrate ingestion.

Interventions

Proprietary Botanical Blend

Oral administration of capsules containing proprietary botanical blend 30 minutes prior to carbohydrate ingestion.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Oral administration of capsules containing rice flour (placebo) 30 minutes prior to carbohydrate ingestion.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Plexus Worldwide

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Lilian de Jonge

Role: CONTACT

edejonge@gmu.edu

7039935153

References

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.

Reference Type: RESULT

PMID: 26160327 (View on PubMed)

Related Links

https://apps.who.int/iris/bitstream/handle/10665/204871/9789241565257_eng.pdf;jsessionid=6CEFCE5876A8E46F48B90A0FAEFFBF9B?sequence=1

WHO Global Report on Diabetes

Other Identifiers

1355505-1

Identifier Type: -

Identifier Source: org_study_id