Clinical trial NCT06836479: Using Continuous Glucose Monitoring to Quantify the Effects of NOURISH's Culturally Modified Meals on Asian Americans With Type 2 Diabetes
Official title: Validation of NOURISH Project's Culturally Tailored Meals on Postprandial Glycemic Response Using Continuous Glucose Monitoring: A Quantitative and Qualitative Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Type 2 Diabetes
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
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Tastermonial Inc
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Positive Area Under the Curve (pAUC) for Blood Glucose
timeFrame: During Week 2, Week 3
Secondary outcomes:
measure: Glucose % Time in Range Over the Course of the Intervention as Compared to the Baseline
timeFrame: During Week 2, Week 3, Week 4
measure: Adherence to NOURISH Diet
timeFrame: 1 week
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Minal Moharir, MD
role: PRINCIPAL_INVESTIGATOR
References: