Acute Effect of HP-211 (Axulin) on Blood Glucose and Serum Insulin Responses in Healthy Lean and Overweight Humans

Summary

Blood sugar levels are controlled by insulin, a hormone made by cells in the pancreas. After a meal, carbohydrates are broken down into glucose (blood sugar) which is absorbed from the intestine into the blood leading to a rise in glucose which triggers the secretion of insulin. Insulin binds to cells in the liver, muscle and fat, triggering them to take up glucose and bring the blood glucose level back to normal.

A high blood sugar level is known as diabetes. The most common form of diabetes, type 2 diabetes, is caused by insulin resistance; that is, a reduced ability of insulin to stimulate glucose uptake into cells. The body compensates for insulin resistance by making more insulin; type 2 diabetes occurs when the pancreas can no longer make enough insulin to control blood glucose. The high blood glucose and insulin levels lead to long-term complications such as heart attacks, kidney failure, reduced sensation and poor circulation in the feet and legs. Reducing blood glucose levels with oral medications and insulin reduces risk of diabetic complications. There are several types of oral medications available for treating diabetes; however, they do not always control blood glucose adequately. In addition, these drugs have complications and are not used to treat insulin resistance and prediabetes - a condition when blood glucose is higher than normal but not high enough to be classified as diabetes. Prediabetes often progresses to diabetes over a period of months or years. Effective and safe treatments for prediabetes could prevent or delay the onset of diabetes.

Axulin is a natural health product consisting of a mixture of extracts - derived from herbs and vegetables present in normal diets - which has been shown in cell culture and in animal studies to increase the ability of insulin to stimulate glucose uptake into cells. The active ingredient in Axulin is a botanical extract designated HP-211. Thus, HP-211 may reduce the blood glucose and insulin levels of subjects without diabetes after eating. HP-211 may also reduce glucose and insulin responses to a larger extent in insulin-resistant as compared to insulin-sensitive subjects.

Subjects will take 0g, 2g, or 4g of capsules or tablets in the morning after an overnight fast; 40 minutes later they will consume 75g glucose dissolved in 300ml water. Blood glucose, insulin and fats will be measured before and for 2 hours after the glucose drink.

Conditions

• Insulin Resistance, Diabetes

Interventions

OTHER

Placebo capsules

250ml water with 16 x 250mg placebo capsules

OTHER

2g capsules

250ml water with 8 x 250mg capsules containing Axulin powder plus 8 x 250mg placebo capsules

OTHER

4g capsules

250ml water with 16 x 250mg capsules containing Axulin powder

OTHER

Water Control

250ml water

OTHER

2g tablets

250ml water with 2 x 1g tablets containing Axulin powder

OTHER

4g tablets

250ml water with 4 x 1g tablets containing Axulin powder

Sponsors & Collaborators

• Glycemic Index Laboratories, Inc

  collaborator INDUSTRY

• Housey Healthcare ULC

  lead INDUSTRY

Principal Investigators

• Thomas MS Wolever, MD, PhD · Glycemic Index Laboratories, Inc

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-04-26

Primary Completion

2017-06-21

Completion

2017-06-21

Countries

• Canada

Study Locations