NCT04047537

Placebo-Controlled Clinical Nutrition Study of the Metabolic Effects of Food Product WBF-0011 in Type 2 Diabetes

A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Metabolic Effects of Two Formulations of a Food Product (WBF-0011) When Administered to Subjects With Type 2 Diabetes Treated With Diet and Exercise Alone or in Combination With Metformin

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Pendulum Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This 12 week placebo-controlled study evaluates the safety and impact of 2 different strengths of the medical food formulation WBF-0011.

Detailed description

The medical food formulations being tested in this study contain butyrate-producing organisms plus a microbial strain that contributes to the integrity of the colonic mucin barrier. The microbes have been fully characterized, certified as Generally Recognized As Safe (GRAS) and manufactured to Good Manufacturing Practice (GMP) standards using excipients that are also GRAS qualified. Subjects will receive their randomized formulation twice a day for 12 weeks.The target population will be patients with Type 2 Diabetes who are not treated with anti-diabetic agents or are treated with metformin alone.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Medical Food Formulation 1	WBF-0011
OTHER	Medical Food Formulation 2	WBF-0011 (0.2X concentration)
OTHER	Placebo	Placebo Capsules identical to those containing Formulation 1 and 2

Timeline

• Start date: 2019-08-06
• Primary completion: 2020-04-15
• Completion: 2020-05-30
• First posted: 2019-08-06
• Last updated: 2022-05-06

Locations

1 site across 1 country: Ireland