Investigating the Effect of Onyx Sorghum on Blood Glucose in Individuals With Type 2 Diabetes

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.

Inclusion Criteria:

- Ages 30-65 years

- A1c < 8.5%

- BMI > 18.5

Exclusion Criteria:

- known malignancy, anemia, kidney disease, and/or liver disease

- untreated thyroid disease

- uncontrolled hypertension

- initiation of any anti-diabetes medications within the last 3 months

- greater than 5% change in weight in the last 3 months

- current or recent steroid use in the last 3 months

- for women: pregnancy or breastfeeding