What is SUGARDOWN®?
Scientists at Boston Therapeutics have optimized the chemistry of a specific plant-derived mannan to develop SUGARDOWN®, our first of several products to address the growing need for blood glucose management. Below is some information about SUGARDOWN®:
- 1. SUGARDOWN® is a chewable tablet eaten before meals.
- 2. SUGARDOWN® supports normal after-meal blood sugar.
- 3. Safe: submitted structure and function claims to the FDA with no comment from the FDA. All ingredients are Generally Regarded as Safe (GRAS).
- 4. Clinically Proven to show reduction in post-meal elevation of blood sugar.
- 5. Made in the USA.
- 6. Manufactured with highest level of integrity and oversight: Good Manufacturing Procedure (GMP), FDA inspected facility.
The Clinical Study
Study Title:Determination of the postprandial glucose and insulin responses of white rice alone and white rice consumed with SUGARDOWN®.
Sponsor:Boston Therapeutics, Inc – 33 S. Commercial St, Manchester, NH 03101, USA and Advance Pharmaceutical Company Limited – Rm.L 3/F, 12 Dai Fu St, Tai Po Industrial Estate, Tai Po, N.T, Hong Kong
Investigator:Prof. Jennie Brand-Miller, Human Nutrition Unit, School of Molecular Bioscience GO8, Sydney University, NSW, 2006, Australia.
Type of research:Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice or white rice consumed with SUGARDOWN® (2 different doses). Each of the three test meals was consumed twice by each of the subjects. Each test meal was consumed on a separate morning and was served in a random order. The Human Research Ethics Committee of the University of Sydney approved the experimental procedures used in this study.
Subjects:10 healthy voluntary subjects (4 females and 6 males) with a mean age of 29.2 years and a mean BMI value of 27.3 kg/m2.
Inclusion Criteria:Healthy non-smokers; aged between 25 – 65 years; stable body weight within the overweight range for height (BMI values > 25 kg/m2);normal dietary and physical activity habits; no history of dieting for the past 3 months; able to fast overnight for ≥ 10 hours before each test session; able to refrain from consuming alcohol the day before a test session; not pregnant or breast-feeding or trying to become pregnant; not taking any medication known to affect blood glucose levels.
Study objectives:1. To determine the postprandial glucose responses of the three test meals.
2. To determine the postprandial insulin responses of the three test meals.
Study period:Duration of study period: 10 weeks: March – June 2011.
First subject commenced study on the 28th March 2011.
Last subject completed their last test session on the 3rd June 2011.
Methodology: Standard postprandial response methodology: Fasting subjects consumed equal-carbohydrate portions of the three test meals (repeated twice) containing 50 grams of available carbohydrate from the white rice. Each meal was tested on a separate occasion. Finger-prick bloodsamples were obtained at –10, 0, 15, 30, 45, 60, 90, 120 min. Plasma glucose and insulin concentrations were measured and the incremental areas under the 120-minute plasma glucose and plasma insulin response curves (iAUC) were calculated.
Test Meals:White Rice: 63.0 g (dry) Jasmine rice consumed together with 250 mL water
White Rice: 63.0 g (dry) Jasmine rice + 3 SUGARDOWN® tablets consumed together with 250 mL water
White Rice: 63.0 g (dry) Jasmine rice + 6 SUGARDOWN® tablets consumed together with 250 mL water
Each test meal was repeated twice by each subject.
Results:There were no serious adverse events reported during the study (before, during or after the test sessions) and none of the subjects withdrew from the study. The addition of up to 3 SUGARDOWN® tablets before a meal reduced the postprandial glucose responses to the white rice up to 61%. Plasma glucose responses were significantly associated with their corresponding insulin iAUC responses (r = 0.78, p = 0.0001).
Applied Carbohydrate Chemistry Platform
Carbohydrates have been shown to play a fundamental role in normal cell functions as well as in major disease pathologies including cancer, cardiovascular disease and inflammatory diseases. As a class of molecules, carbohydrates have an enormous range of shape, orientation and composition. Due to this structural diversity, carbohydrate chemistry can be applied to develop a broad range of complex therapeutic molecules and drugs, including pure carbohydrates as well as protein-linked carbohydrates, or glycoproteins. However, as a consequence of their structural complexity, carbohydrates have not received as much scientific attention as nucleic acids and proteins. We view this technology gap as a unique opportunity to apply our expertise in carbohydrate engineering to develop therapeutic molecules for unmet medical needs.
Boston Therapeutics’ technology platform in applied carbohydrate chemistry has been pioneered by our CEO David Platt and his scientific collaborators over the last 20 years and is summarized in two recent books that he co-edited, “Carbohydrate Drug Design (2006)” and “Galectins (2008)”. Our deep domain experience in engineering complex carbohydrates has enabled us to pursue a unique pipeline of carbohydrate-based therapeutics that addresses unmet medical needs both safely and effectively. These proprietary formulations include modified versions of mannan and pectin, as well as a number of other proprietary and beneficial polysaccharides.
Mannan and the Glycemic Index
The active ingredient in our product SUGARDOWN®, which is designed to address the growing need for blood sugar management, is a proprietary fractionated mannan. Mannans are a group of plant-derived complex carbohydrates, or polysaccharides, which consist mainly of polymers of the sugar mannose. Some of the plants from which mannans are derived are guar, locust bean, fenugreek, barley and konjac. Published studies on mannans have shown that they possess significant biological activity ranging from inhibition of cholesterol absorption to promoting wound healing and inhibiting tumor growth. Studies have also shown that consuming mannan before a meal can lessen the rise in blood glucose after the meal. Therefore, supplementation with mannan may be beneficial in the management of diabetes by supporting healthy blood sugar levels.
The modified mannan in SUGARDOWN® works to moderate the rise in post-meal blood glucose in several ways. First, it binds to long-chain starch polysaccharides in food and to the digestive enzymes that cleave these large sugars into glucose. Second, it temporarily coats the lumen of the small intestine to slow the absorption of glucose. Finally, BTI’s mannan induces satiety, thereby facilitating portion control as a secondary benefit.
Together, these mechanisms of action lower the rate of absorption of glucose from the small intestine into the blood.
In a research effort to find out which foods are best in terms of blood sugar control for those with diabetes, the concept of the glycemic index, or GI, was developed at a leading university in Toronto, Canada in 1980. Foods containing carbohydrates that break down quickly and easily during digestion, and thus release glucose rapidly into the bloodstream, have a high GI; foods containing carbohydrates that break down more slowly resulting in a gradual release of glucose, have a low GI. A lower GI may also result in a lower insulin response and thereby, improves long-term blood glucose control in both healthy and diabetic individuals.
Based on the body of scientific evidence for the mechanisms of how mannans work, we have optimized the formulation of mannans in SUGARDOWN® Chewable Tablets to slow down the post-meal digestion and absorption of glucose in order to moderate blood sugar levels. Therefore, the dietary addition of SUGARDOWN® may effectively reduce the total glycemic load in a high glycemic meal and may aid in the control of blood glucose levels in diabetics, pre-diabetics and others with metabolic syndrome.