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

Yale University

Status: Completed

Conditions: Diabetes Type 2

Treatments: Dietary Supplement: onyx sorghum; Dietary Supplement: whole wheat flour

Study type: Interventional

Funder types: Other

Identifiers

NCT03714451

2000023930

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups

Onyx Group

Experimental group

Description:

Patients with T2DM will receive food products containing onyx sorghum (Onyx Group).

Treatment:

Dietary Supplement: onyx sorghum

Wheat Flour Group

Active Comparator group

Description:

Patients with T2DM will receive food products with wheat flour.

Treatment:

Dietary Supplement: whole wheat flour