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Clinical Trial Summary

To evaluate the effect of onyx sorghum on blood glucose levels in patients with type 2 diabetes (T2DM).


Clinical Trial Description

The plan is to study 24 participants with T2DM, who are otherwise healthy. The study will be double-blinded and randomized. Participants will first attend a screening visit (Visit #1) to determine eligibility. Then, eligible participants will be asked to wear a FreeStyle Libre Pro continuous glucose monitor (CGM) for up to 14 days (Visit #2). After this 14-day CGM session, participants will be randomly assigned (1:1) to one of two groups that will receive: 1) food products containing onyx sorghum (Onyx Group) or 2) food products with wheat flour (Control Group). The diet intervention will last a total of 28 days. Participants will have weekly visits to pick up food and bi-weekly blood draws (no more than 20mL at each visit). They will also be asked to wear the CGM throughout the diet intervention and will record their food intake in a daily food diary to confirm that the diet intervention is being followed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03714451
Study type Interventional
Source Yale University
Contact
Status Completed
Phase N/A
Start date November 1, 2018
Completion date December 30, 2022

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