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Study to Assess Safety and Effect of a Prebiotic Fiber Meal Replacement Shake in Individuals With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Effect on Quality of Life of a Prebiotic Fiber Meal Replacement Shake in Individuals With Type 2 Diabetes

Clinical Trial Summary

This study is a double-blind, randomized, trial of a commercially available meal-replacement shake versus a placebo control designed to evaluate the impact on quality of life, safety, and tolerability. It also includes a randomized, non-blinded third arm consisting of only dietary guidelines.

Clinical Trial Description

A total of 147 participants will be recruited for the study following screening, with the expectation that approximately 131 participants will complete the trial. The 147 participants will be randomized to the three different study arms in a 2:1:1 ratio with the commercially available meal-replacement shake group being the one favored, i.e., 73 participants in that arm and 37 in the other two arms. The trial will be mostly virtual, with in-person visits to a laboratory facility for blood draws, as well as standardized BMI calculations, waist circumference, and blood pressure readings. A technology platform will be utilized to screen, enroll and capture study data of the participants. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05110703
Study type Interventional
Source Uplifting Results Labs Inc.
Contact
Status Completed
Phase N/A
Start date October 11, 2021
Completion date March 1, 2022
View Details
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