- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06836479
Using Continuous Glucose Monitoring to Quantify the Effects of NOURISH's Culturally Modified Meals on Asian Americans With Type 2 Diabetes
Validation of NOURISH Project's Culturally Tailored Meals on Postprandial Glycemic Response Using Continuous Glucose Monitoring: A Quantitative and Qualitative Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stephanie Ibe
- Phone Number: 732-610-1929
- Email: stephibe@stanford.edu
Study Contact Backup
- Name: Reha Shah
- Phone Number: 408-805-0581
- Email: rshah5@stanford.edu
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Recruiting
- Stanford University
-
Contact:
- Sania Srivastava
- Phone Number: 734-460-2275
- Email: saniasri@stanford.edu
-
Contact:
- Mehek Parghi
- Phone Number: 510-512-0586
- Email: mparghi@stanford.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self Selected Diet to NOURISH Diet
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.
|
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.
Other Names:
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.
Other Names:
|
|
Experimental: NOURISH Diet to Self-Selected Diet
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.
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Positive Area Under the Curve (pAUC) for Blood Glucose
Time Frame: 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.
|
During Week 2, Week 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glucose % Time in Range Over the Course of the Intervention as Compared to the Baseline
Time Frame: 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.
|
During Week 2, Week 3, Week 4
|
|
Adherence to NOURISH Diet
Time Frame: 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" |
1 week
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Minal Moharir, MD, Stanford University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 78525
- P30DK116074 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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