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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • NOURISH Diet

    Other intervention

    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.

  • Self-Selected Diet (Control)

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Self Selected Diet to NOURISH DietExperimental treatment 2 interventions
Group B: NOURISH Diet to Self-Selected DietExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
During Week 2, Week 3

Secondary outcomes

1

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.

Time frame
During Week 2, Week 3, Week 4
2

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"

Time frame
1 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Tastermonial Inc

Collaborator