NAD Finds Health-Related Claims for Pendulum Glucose Control Medical Probiotic Supported but Recommends Some Modifications
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- “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.”
However, NAD recommended the following modifications so that the claims more accurately reflect the limitations in the evidence by:
- Limiting the claims to individuals who are taking metformin;
- Modifying the claims to clarify that the product can be used as part of the dietary management of type 2 diabetes; and
- Removing references to percent reductions in blood glucose spikes in the absence of evidence in the record demonstrating that the reductions were clinically relevant.
The claims at issue were challenged as part of NAD’s routine monitoring program. During the pendency of the case, the advertiser voluntarily modified many of the challenged claims permanently, therefore, NAD did not review these claims on the merits.
In support of its claims, the advertiser chiefly relied on the Perraudeau Study assessing Pendulum Glucose Control’s effectiveness in helping Type 2 diabetes dietary management. NAD determined that this 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). However, NAD questioned certain aspects of the study related to test population and clinical relevance of the endpoints.
Based on its assessment, NAD determined that the Perraudeau study was a good fit for the challenged claims but recommended the previously noted modifications.
In its advertiser statement, Pendulum Therapeutics, Inc. stated that it “is pleased with NAD’s decision and will comply with its recommendations.”
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