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| Name | Class |
|---|---|
| Silver Palate Kitchens Inc. | UNKNOWN |
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To evaluate the effect of onyx sorghum on blood glucose levels in patients with type 2 diabetes (T2DM).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Onyx Group | Experimental | Patients with T2DM will receive food products containing onyx sorghum (Onyx Group). |
|
| Wheat Flour Group | Active Comparator | Patients with T2DM will receive food products with wheat flour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| onyx sorghum | Dietary Supplement | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in weight | change in weight from baseline | day 1 |
| Changes in weight | change in weight from baseline | day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Eating behavior | measure of food provided and returned | day 1 |
| Eating behavior | measure of food provided and returned | day 14 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renata Belfort de Aguiar, MD, PhD | Yale School of Medicine Department of Endocrinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States | ||
| Yale University School of Medicine |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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double blinded randomized
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double blinded
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| whole wheat flour | Dietary Supplement | 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. |
|
| 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 |
| Eating behavior | measure of food provided and returned | day 28 |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Yale Center for Clinical Investigation | New Haven | Connecticut | 06519 | United States |
| D004700 | Endocrine System Diseases |