Using Continuous Glucose Monitoring to Quantify the Effects of NOURISH's Culturally Modified Meals on Asian Americans With Type 2 Diabetes

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM); Type 2 Diabetes

• Registration Number: NCT06836479
• Lead Sponsor: Stanford University

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Study Start: 2025-04
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Self-identification as Asian Indian or Filipino
• Diagnosed with T2DM
• Can pick up meals from a designated area on the Stanford Campus
• Willing to wear a CGM for 30 days

Exclusion Criteria

• Currently taking insulin, GLP -1 and SGLT 2
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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"

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States