Type 2 Diabetes Mellitus (T2DM)NCT06836479
Using Continuous Glucose Monitoring to Quantify the Effects of NOURISH's Culturally Modified Meals on Asian Americans With Type 2 Diabetes
A study testing NOURISH Diet in people with Type 2 Diabetes Mellitus (T2DM) and Type 2 Diabetes, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
- What is being tested?
- NOURISH Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
Arati Nagarkar, 619-241-6884, arati.nagarkar@stanford.edu
Mehek Parghi, 510-512-0586, mparghi@stanford.edu
About this study
Official title: Validation of NOURISH Project's Culturally Tailored Meals on Postprandial Glycemic Response Using Continuous Glucose Monitoring: A Quantitative and Qualitative Study
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
- Being tested
- NOURISH Diet, Self-Selected Diet (Control)
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOURISH DietOther
Also called NOURISH-modified meals, NOURISH meals
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
Also called Routine Diet, Baseline, 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.
| Study group | Role | What they receive |
|---|---|---|
| Self Selected Diet to NOURISH Diet | Experimental | 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. Receives: Other: NOURISH Diet; Other: Self-Selected Diet (Control) |
| NOURISH Diet to Self-Selected Diet | Experimental | 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. Receives: Other: NOURISH Diet; Other: Self-Selected Diet (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During Week 2, Week 3
Secondary outcomes (2)
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.
Measured: During Week 2, Week 3, Week 4
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"
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start31 Aug 2026
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Tastermonial Inc
- Responsible party
- Principal investigator, Minal Moharir, Stanford University
- Investigators
- Minal Moharir, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836479
- Sponsor's protocol ID
- 78525
- Status last verified
- Sep 2026
- First submitted
- 14 Feb 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of NOURISH Project's Culturally Tailored Meals on Postprandial Glycemic Response Using Continuous Glucose Monitoring: A Quantitative and Qualitative Study
- ClinicalTrials.gov ID
- NCT06836479
- Acronym / sponsor ID
- 78525
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Tastermonial Inc
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self Selected Diet to NOURISH Diet | Experimental | Other: NOURISH Diet, Other: Self-Selected Diet (Control)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. |
| NOURISH Diet to Self-Selected Diet | Experimental | Other: NOURISH Diet, Other: Self-Selected Diet (Control)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOURISH DietAlso: NOURISH-modified meals, NOURISH mealsNOURISH 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 | NOURISH Diet to Self-Selected Diet, Self Selected Diet to NOURISH Diet |
| Self-Selected Diet (Control)Also: Routine Diet, Baseline, ControlThe 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 | NOURISH Diet to Self-Selected Diet, Self Selected Diet to NOURISH Diet |
Primary outcome
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.
2 secondary outcomes
Glucose % Time in Range Over the Course of the Intervention as Compared to the Baseline
Time frame: During Week 2, Week 3, Week 4
Adherence to NOURISH Diet
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Mellitus (T2DM)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Minal Moharir, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOURISH Diet in people with Type 2 Diabetes Mellitus (T2DM) and Type 2 Diabetes, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive Area Under the Curve (pAUC) for Blood Glucose (time frame: During Week 2, Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.