Novoglucose Study
Research type
Research Study
Full title
DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF THE PROBIOTIC STRAINS LIMOSILACTOBACILLUS REUTERI DSM 32910 AND LACTICASEIBACILLUS PARACASEI DSM 32851 ON GLUCOSE HOMEOSTASIS IN PREDIABETIC ADULTS
IRAS ID
295204
Contact name
Gordon Crawford
Contact email
Sponsor organisation
Biofortis
Duration of Study in the UK
1 years, 7 months, 3 days
Research summary
This study has been designed to investigate the effect of a probiotic supplement on helping maintain healthy blood sugar levels in the body.
Sugars are a type of carbohydrate and a main source of energy for the body. They are an important part of our diet and are present in nearly everything that we eat. The body helps control the levels of sugar in the body by either breaking down, storing, or creating new sugars to meet the needs of our daily activity. A hormone from the pancreas, called insulin, plays a key role in helping keep our sugar levels under control. Over time however, too much sugar in the body can lead to resistance to insulin as eventually the body struggles to cope. Simply speaking, the body starts to ignore insulin and blood sugar levels begin to go out of control. Eventually this can lead to what we recognize as Type 2 Diabetes.
An early sign that the body is struggling is related to the blood sugar being a bit higher than it should be, but not high enough to cause disease. This is a state commonly known as ‘prediabetes’ and can be checked in a couple of ways. One way is to see what the blood sugar levels are during a fast (after a period of not eating). The other is by checking blood levels of something called HbA1c, a general measure of your blood sugar over time related to your red blood cells. Once confirmed, prediabetes means a high risk of developing diabetes in the future.
Blood sugar is closely related to our food intake and digestion, which happens in our guts. Inside of our guts we can find an enormous number of bacteria forming what is called the gut microbiota. What seems to be important about the gut microbiota for health, is diversity. This means having lots of different types of bacteria, including the right types of bacteria.
Based on previous research, it is believed that supplementing specific lactobacilli bacteria can help create a healthier gut environment to promote both blood sugar control and insulin sensitivity. The study Sponsor has developed a probiotic supplement combining two types of lactobacilli that were chosen specifically for this reason.
The main objective of the study is to find out the effect of taking these lactobacilli as a regular probiotic supplement over a 16-week period, by looking for an improvement in HbA1c.REC name
East of Scotland Research Ethics Service REC 1
REC reference
21/ES/0028
Date of REC Opinion
24 Feb 2021
REC opinion
Favourable Opinion