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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03897517
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hyperglycemia Carbohydrate Insulin Resistance Malabsorption Dietary Supplement: Proprietary Botanical Blend Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Participant, Investigator)
Masking Description: Treatment and placebo will be matched closely in color and appearance administered in a double blinded fashion as provided by the material supplier.
Primary Purpose: Prevention
Official Title: Effect of Proprietary Botanical Blend on Glycemic Control and Post-prandial Carbohydrate Absorption in Overweight, Insulin Resistant Adult Men and Women
Estimated Study Start Date : August 30, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Proprietary Botanical Blend
Proprietary Botanical Blend - Dietary supplement with alpha amylase and sucrase inhibitory activity. 2 capsules
Dietary Supplement: Proprietary Botanical Blend
Oral administration of capsules containing proprietary botanical blend 30 minutes prior to carbohydrate ingestion.

Placebo Comparator: Placebo
Non/minimally nutritive nonactive material: rice flour. 2 capsules
Dietary Supplement: Placebo
Oral administration of capsules containing rice flour (placebo) 30 minutes prior to carbohydrate ingestion.




Primary Outcome Measures :
  1. Post Prandial Glycemia [ Time Frame: 3 weeks ]
    Plasma glucose concentrations after the ingestion of a high carbohydrate meal

  2. Breathe hydrogen concentration [ Time Frame: 3 weeks ]
    Measurement of hydrogen in exhaled air as an indicator of carbohydrate absorption



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897517


Contacts
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Contact: Lilian de Jonge 7039935153 edejonge@gmu.edu

Sponsors and Collaborators
Plexus Worldwide

Additional Information:
Publications of Results:
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Responsible Party: Plexus Worldwide
ClinicalTrials.gov Identifier: NCT03897517    
Other Study ID Numbers: 1355505-1
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Plexus Worldwide:
Glycemia
Carbohydrate blocker
Additional relevant MeSH terms:
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Malabsorption Syndromes
Insulin Resistance
Hyperglycemia
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases