Our published clinical study, explained
A straightforward guide to our published clinical study.
This guest post is written by Hope Warshaw, MMSc, RD, CDCES, BC-ADM. Hope is a Registered Dietitian (RD) and Certified Diabetes Care and Education Specialist (CDCES) who has been involved in diabetes care, education and support for over forty years. She has and continues to apply her credentials as a consultant, book author, freelance writer and media spokesperson within her business, Hope Warshaw Associates, LLC, a consultancy based in Asheville North Carolina. Hope serves as a consultant to Pendulum Therapeutics.
More often than not, the organ people typically associate diabetes with is the pancreas. That’s because historically the management of diabetes has focused on insulin, the hormone produced and secreted from the pancreas. Suffice to say, our collective understanding of how people develop type 1 or type 2 diabetes has greatly evolved and they’re actually quite different. This blog post focuses on type 2 diabetes and zeroes in on positive outcomes from a study in people with type 2 diabetes, which studied the use of Pendulum Glucose Control that aims to help with glucose control through improved function of the gut microbiome. Overall, the study showed a significant improvement in both short and longer term measures of glucose control after eating.
Let’s explore the details.
This study was conducted due to a growing body of research that has shown several changes that occur in the gut microbiome of people with type 2 diabetes. This includes lower-than-usual amounts of certain naturally occurring gut bacteria, specifically the healthy microbe Akkermansia muciniphila and other microbes that converts some of the dietary fiber one consumes into short-chain fatty acids, particularly one named butyrate. Butyrate supports digestive health and helps reduce chronic inflammation. The results of these changes in people with type 2 diabetes can result in a weaker barrier between the gut and the bloodstream and lower production of butyrate. In contrast, research shows that a stable gut barrier and sufficient butyrate production are important to maintaining a healthy gut and normal glucose levels.
The hypothesis of this study was that people diagnosed with type 2 diabetes taking a novel synbiotic (probiotic & prebiotic) product that contains butyrate-producing bacteria and Akkermansia muciniphila regularly would experience improved glucose control. The product tested in this study was Pendulum Glucose Control.
The study tested two formulations of the synbiotic both taken two times a day. The study lasted 12 weeks. It was a randomized, parallel (meaning the study was conducted at the same time), double-blind (meaning neither the participants nor the researchers knew who were in each study group), and placebo-controlled (meaning people were randomly assigned to either receive one of the synbiotics or placebo) study.
76 people with type 2 diabetes located in six study sites were included in this study. Their type 2 diabetes was being managed with healthy eating and physical activity alone, combined with a glucose-lowering medication called metformin, or in some cases one other category of medication called sulfonylureas. Most participants were overweight or obese, had A1C levels ranging from 8.5 – 8.9%, and fasting glucose levels ranging from 179 – 208 mg/dL.
Interestingly it has been conjectured that metformin, which is a widely used initial medication to manage type 2 diabetes, may assist in improving gut health by increasing butyrate and Akkermansia muciniphila.
Study participants who received Pendulum Glucose Control in comparison to the placebo group showed clinically significant improvements in glucose levels. Glucose levels were measured in two ways: 1) by a meal-tolerance test, which shows the rise of glucose over three hours after consuming a standardized liquid beverage (results reported as glucose area under the curve), and 2) by an A1C test (see sidebar). The glucose area under the curve improved by 36 mg/dL over 180 minutes and the A1C improved by 0.6% compared to the placebo results. It is important to note that there were no safety concerns or issues tolerating the synbiotic during the study.
What do these results mean for people with type 2 diabetes?
What is glucose management?
It’s easy to be confused by the numbers that the American Diabetes Association recommends for the diagnosis of diabetes and the bull’s eye (management targets) to keep glucose results and A1C within. Once you’ve been diagnosed with diabetes you want to know and try to reach the management targets. (Diagnostic targets are different.)
Do discuss with your healthcare provider how often you should have an A1C check done. Also discuss how (whether with a Blood Glucose Meter or personal Continuous Glucose Monitor) and how often to check your glucose levels.
Key ways to measure your glucose levels:
- A1C: The goal for many non-pregnant adults is: <7%, but you and your provider may decide that a less stringent goal of <8%, is appropriate for you bearing in mind your personal medical situation and other factors. A1C is reported as a percent and is one number. It gives a sense of all the ups and downs of your glucose levels over the last two to three months. It doesn’t give you specifics about the ups and downs of your glucose levels like checking your glucose levels does.
- Glucose levels:
- Before meals and fasting: 80 – 130 mg/dL
- After eating (1-2 hours after the beginning of meals): <180 mg/dL
- Perraudeau F, McMurdie P, Bullard J, et al. Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation. BMJ Open Diabetes Research and Care. 2020;8:e001319. doi: 10.1136/bmjdrc-2020-001319.
- American Diabetes Association. 6. Glycemic targets: standards of medical care in diabetes - 2020. Diabetes Care. 2020;43(suppl 1):S66-S76.