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| Name | Class |
|---|---|
| Tastermonial Inc | INDUSTRY |
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The investigators are hoping to determine whether tailoring the diet of someone with type 2 diabetes to their ethnic group while following American Diabetes Association guidelines can make a significant difference in their blood sugar controls. Participants will be required to wear a Continuous Glucose Monitor (CGM) for 1-month so that the investigators can compare blood sugar levels when participants are eating their routine diet vs. the culturally tailored diabetes diet.
This clinical trial evaluates the impact of culturally tailored, American Diabetes Association (ADA)-compliant meals on the glycemic control of Asian Indian and Filipino individuals with Type 2 Diabetes Mellitus (T2DM). This study leverages a crossover design to compare glycemic responses during two distinct dietary phases: a self-selected diet phase (baseline/control/routine diet) and an intervention phase featuring NOURISH meals. NOURISH Meals will be delivered to designated pick-up points on the Stanford campus and Stanford clinics. Participants will be equipped with Continuous Glucose Monitors (CGMs) to track glucose trends across the study and will be required to keep a food log through Tastermonial, enabling detailed analysis of postprandial glucose responses and key metrics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self Selected Diet to NOURISH Diet | Experimental | Participants in this arm will be consuming self-selected meals (baseline/control) first (During Week 2 of the intervention), followed by the NOURISH diet in the next week (Week 3). Participants will be required to fill out a food diary and questionnaires using the Tastermonital app. |
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| NOURISH Diet to Self-Selected Diet | Experimental | Participants in this arm will be consuming the NOURISH diet first (During Week 2 of the intervention), followed by their self-selected diet (baseline/control) in the next week (Week 3). Participants will be required to fill out a food diary and questionnaires using the Tastermonital app. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOURISH Diet | Other | NOURISH meals will be prepared by NOURISH chefs for seven days. Both South Asian and Filipino meal plans will be prepared, vegetarian, vegan and non-vegetarian options available for all. Participants will pick-up NOURISH meals at a Stanford facility and consume three meals (breakfast, lunch, and dinner) and two snacks over one week. There will be no caloric restriction, the calories in each meal will be informed by the average intake for the participants gender and BMI. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Positive Area Under the Curve (pAUC) for Blood Glucose | Upon analysis of the CGM data graphs, the area under the curve will be analyzed. The goal is to observe the difference in glucose levels when participants consume NOURISH meals versus the self-selected diet. Higher pAUC values indicate higher average blood glucose and possibly decreased glycemic control, whereas lower pAUC values indicate lower average blood glucose and possibly increased glycemic control. | During Week 2, Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose % Time in Range Over the Course of the Intervention as Compared to the Baseline | Using the glucose readings from the continuous glucose monitors, the daily glucose values for participants will be plotted. Analysis will be done to identify the %-proportion of time participant's glucose levels fall within a pre-specified range. Area values for both the self-selected diet and NOURISH diet will be compared for each participant and tested for statistical significance. Higher glucose %-time in range indicates that the glucose fell within a certain range for a larger portion of time, lower glucose %-time in range indicates that glucose deviated out of the specified range. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Ibe | Contact | 732-610-1929 | stephibe@stanford.edu | |
| Reha Shah | Contact | 408-805-0581 | rshah5@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Minal Moharir, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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| Self-Selected Diet (Control) | Other | The participants will eat their routine meals without any involvement of the investigators. Participants will be required to wear the CGM during this time and keep a detailed food log through Tastermonial. |
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| During Week 2, Week 3, Week 4 |
| Adherence to NOURISH Diet | Participants will be performing journal logs throughout the study via the Tastermonial app. They will be required to upload information on how much of the meal they consumed and if they replaced the NOURISH meal with a self-selected one for any reason. Analysis will be conducted to understand the number of meals and days participants adhered to NOURISH meals and the blood glucose levels measured. Question asked to participants: "What proportion of this meal did you consume?" Answer choices: "I did not eat this meal at all", "25%", "50%". "75%", "I finished the full meal" | 1 week |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C074807 | BaseLine dental cement |
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