Diabetes Type 2
Conditions
Brief summary
To evaluate the effect of onyx sorghum on blood glucose levels in patients with type 2 diabetes (T2DM).
Detailed 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.
Interventions
DIETARY_SUPPLEMENTonyx sorghum
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.
DIETARY_SUPPLEMENTwhole wheat flour
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.
Sponsors
Silver Palate Kitchens Inc.
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double blinded
Intervention model description
double blinded randomized
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycemic variability | day 1 | The continuous glucose monitoring (CGM) consists of a sensor that measures glucose levels from the interstitial tissue. Changes in glucose levels from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in weight | day 1 | change in weight from baseline |
| Changes in BMI | upon screening | change in BMI from baseline |
| Change in glucose levels | upon enrollment | change in blood glucose levels |
Other
| Measure | Time frame | Description |
|---|---|---|
| Eating behavior | day 1 | measure of food provided and returned |
Countries
United States
Outcome results
None listed