Type 2 Diabetes Mellitus Clinical Trial
Official title:
An Placebo-Controlled Clinical Nutrition Study to Evaluate the Metabolic Effects of Two Medical Food Products in Subjects With Type 2 Diabetes Treated With Diet and Exercise Alone or in Combination With Metformin ± Sulfonylurea
This 16 week placebo-controlled study evaluates the safety and impact of two medical food study products, WBF10 and WBF11, consisting of commensal microbes. The primary endpoints were safety, glucose AUC during meal tolerance test and C reactive protein (CRP)..
Targeting the microbiome for treating metabolic syndrome has been gaining traction with
multiple population studies demonstrating a difference between healthy individuals and
patients with metabolic syndrome. Whole Biome has identified and created two medical food
formulations (MFFs) aimed at improving metabolic syndrome via two mechanisms of action
targeting the microbiome: (1) increasing butyrate production and (2) increasing mucin
regulation.
This randomized, parallel-group, placebo-controlled, double-blinded study assesses the safety
and metabolic effects of 2 MFFs on glucose control and the generalized inflammatory state
associated with Type 2 Diabetes. The microbes have been fully characterized, certified as
Generally Recognized As Safe (GRAS) and manufactured to Good Manufacturing Practice (GMP)
standards. The target population was patients with Type 2 Diabetes who either had not been
treated with antidiabetic agents or treated with metformin +/- a sulfonylurea. Subjects were
randomized in a balanced manner to receive capsules containing placebo, WBF10 or WBF11.
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