Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Type 2 Diabetes, Asian American, Asian Indian, Filipino, Medically Tailored Meals, Culture, Culturally Tailored Meals, Continuous Glucose Monitoring, Nutritional Interventions, Dietary Adherence, Diabetes Management
Brief summary
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.
Detailed description
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.
Interventions
OTHERNOURISH Diet
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.
OTHERSelf-Selected Diet (Control)
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.
Sponsors
Stanford University
Tastermonial Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Self-identification as Asian Indian or Filipino * Diagnosed with T2DM * Pick up and consume personally tailored cultural food and meal options for 1 week * Willing to wear a CGM for 30 days
Exclusion criteria
* Currently taking insulin * Known severe allergic reactions and/or food intolerances that would interfere with the ability to eat * Those who, in the opinion of the investigators, cannot reliably complete the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Positive Area Under the Curve (pAUC) for Blood Glucose | During Week 2, Week 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose % Time in Range Over the Course of the Intervention as Compared to the Baseline | During Week 2, Week 3, Week 4 | 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. |
| Adherence to NOURISH Diet | 1 week | 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" |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMinal Moharir, MD
Stanford University
Outcome results
None listed