NAD supports claims being made by ‘medical probiotic’ manufacturer
The NAD ruling said that the scientific study that Pendulum Therapeutics submitted in response to the action support the claims it has been making. The specific claims the ruling said were supported on the Pendulum Glucose Control product are:
- “The only medical probiotic clinically shown to lower A1C & blood glucose spikes for the dietary management of T2D* (*Consult your physician as part of your total diabetes management plan. Results may vary from person to person)”; and
- “The only probiotic clinically shown to lower glucose spikes by 33% and reduce A1C levels by 0.6 in people with type 2 diabetes.”
Pendulum created new category of probiotics
Pendulum CEO Colleen Cutcliffe, PhD, told NutraIngredients-USA in June 2020 that her company was on the cutting edge of a new category that she called ‘medical probiotics.’
“Medical probiotics are a new category of probiotics that deliver clinical efficacy for the management of specific disease or condition with targeted and novel probiotic strains.”
Pendulum Glucose Control was launched in 2020. The product contains inulin and the proprietary probiotic strains Akkermansia municiphilia WB-STR-0001, Eubacterium hallii WB-STR-0008, Clostridium butyricum WB-STR-006, Clotridium beijerinckii WB-STR-0005 and Bifidobacterium infantis 100.
The product is said to stimulate the production of butyrate within the gut as well stimulate the production of mucin, which is beneficial in maintaining good gut barrier function. Both are down regulated in type 2 diabetes, according to the company’s research. The company’s product is backed by a study published it the journal BMJ Open Diabetes Research and Care.
The NAD claims review was initiated as part of the group’s regulator monitoring of the marketplace. Pendulum Therapeutics relied on the BMJ paper to support its claims.
NAD: Study by and large supports claims; some changes recommended
NAD said the study had some appropriate methodological components (double-blind, randomized, placebo-controlled, sufficiently large sample size to elicit statistically significant and clinically meaningful results, testing the marketed product, clearly defined endpoints). The panel further determined that the study was a good fit for Pendulum’s claims, but recommended the following modifications:
- Limiting the claims to individuals who are already taking metformin
- Modifying the claims to clarify that the product can be used as part of the dietary management of type 2 diabetes
- Removing references to percent reductions in blood glucose spikes in the absence of evidence in the record demonstrating that the reductions were clinically relevant.
Pendulum Therapeutics, in its advertiser statement, a standard feature of NAD decisions, said that it, “Is pleased with NAD’s decision and will comply with its recommendations.”
Source: BMJ Open Diabetes Research and Care
2020 Jul;8(1):e001319. doi: 10.1136/bmjdrc-2020-001319
Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation
Authors: Perraudeau F, et al.