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

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

Detailed Description
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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.

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

Conditions
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Diabetes Type 2

Intervention / Treatment
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* Dietary Supplement: onyx sorghum
* Dietary Supplement: whole wheat flour


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blinded randomized
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Onyx Group<br>Patients with T2DM will receive food products containing onyx sorghum (Onyx Group). | Dietary Supplement: onyx sorghum<br>* The diet intervention will last a total of 28 days. Per the American Heart Association (AHA) and American Diabetes Association (ADA) recommendations, the daily diet plan will consist of 50-55% carbohydrate, 15-20% protein, and 25-30% fat. In the Onyx Group, 25% of carbohydrate will come from the onyx sorghum, and at least three foods per day (including cereals, bread, muffins, pasta, and smoothie boosters) will contain this.<br>|
| Active Comparator: Wheat Flour Group<br>Patients with T2DM will receive food products with wheat flour. | Dietary Supplement: whole wheat flour<br>* Per the American Heart Association (AHA) and American Diabetes Association (ADA) recommendations, the daily diet plan will consist of 50-55% carbohydrate, 15-20% protein, and 25-30% fat.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycemic variability | The continuous glucose monitoring (CGM) consists of a sensor that measures glucose levels from the interstitial tissue. Changes in glucose levels from baseline. | day 1 | 
| Change in glycemic variability | The continuous glucose monitoring (CGM) consists of a sensor that measures glucose levels from the interstitial tissue. Changes in glucose levels from baseline. | 14 days | 
| Change in glycemic variability | The continuous glucose monitoring (CGM) consists of a sensor that measures glucose levels from the interstitial tissue. Changes in glucose levels from baseline. | day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in weight | change in weight from baseline | day 1 | 
| Changes in weight | change in weight from baseline | day 14 | 
| Changes in weight | change in weight from baseline | day 28 | 
| Changes in BMI | change in BMI from baseline | upon screening | 
| Changes in BMI | change in BMI from baseline | day 1 | 
| Changes in BMI | change in BMI from baseline | day 14 | 
| Changes in BMI | change in BMI from baseline | day 28 | 
| Change in glucose levels | change in blood glucose levels | upon enrollment | 
| Change in glucose levels | change in blood glucose levels | day 1 | 
| Change in glucose levels | change in blood glucose levels | day 14 | 
| Change in glucose levels | change in blood glucose levels | day 28 |