Culturally Modified Diet for Type 2 Diabetes

Overseen By Reha Shah

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Insulin, GLP-1, SGLT-2

Disqualifiers: Severe allergies, Food intolerances, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if customizing the diet of individuals with type 2 diabetes to their cultural background can improve blood sugar control. Participants will try NOURISH's Culturally Modified Meals, tailored to their ethnic group while adhering to diabetes guidelines. Their blood sugar will be monitored using a Continuous Glucose Monitor (CGM) for a month. The study seeks individuals who identify as Asian Indian or Filipino, have type 2 diabetes, and can pick up meals from the Stanford Campus. As an unphased trial, it offers a unique opportunity to explore personalized dietary approaches for better diabetes management.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking insulin, GLP-1, or SGLT-2 medications.

What prior data suggests that the NOURISH's Culturally Modified Meals are safe for people with type 2 diabetes?

Research has shown that diets adjusted to fit cultural preferences can be well-tolerated by people with type 2 diabetes. Studies have found that when meals are tailored to cultural tastes, individuals are more likely to adhere to them and manage their blood sugar effectively. This can lead to better health without introducing new risks.

No specific reports indicate negative effects from eating culturally tailored meals. Generally, adapting traditional foods to meet health guidelines is seen as a positive step. This approach respects personal and cultural preferences, making it easier for individuals to maintain healthy eating habits.

In summary, eating culturally modified meals is considered safe and can be a comfortable way to manage diabetes while staying connected to cultural roots. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NOURISH Culturally Modified Meals for Type 2 Diabetes because they offer a personalized approach to managing the condition. Unlike standard treatments that often rely on medication or generalized dietary guidelines, NOURISH meals are tailored to fit cultural dietary preferences, potentially making it easier for individuals to stick to a healthier eating plan. This unique approach aims to improve diet adherence and overall health outcomes by integrating cultural and personal preferences into diabetes management. Additionally, the use of the Tastermonital app for tracking meals and feedback provides a modern, tech-savvy way to engage participants actively in their health journey.

What evidence suggests that NOURISH's Culturally Modified Meals might be an effective treatment for type 2 diabetes?

Research has shown that diets tailored to cultural preferences can help people with type 2 diabetes control their blood sugar. One study found that participants who followed a diet based on their cultural foods managed their diabetes better and improved their eating habits after six months. In this trial, participants will follow the NOURISH diet, which adjusts traditional meals to meet American Diabetes Association guidelines, making it easier to adhere to. By eating familiar foods, individuals may find it simpler to stick to their diets and manage their diabetes more effectively. This approach combines personal cultural tastes with proven dietary guidelines, potentially leading to better health outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Minal Moharir, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for Asian Americans with type 2 diabetes who may also have hypertension. Participants will need to wear a Continuous Glucose Monitor (CGM) for one month and are willing to try a culturally modified diet.

Inclusion Criteria

Self-identification as Asian Indian or Filipino

I have been diagnosed with type 2 diabetes.

I can pick up meals from a specific place at Stanford.

Exclusion Criteria

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.

I am currently taking insulin, GLP-1, and SGLT2 medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline/Control Diet

Participants consume their self-selected diet to establish baseline glucose levels

1 week

No in-person visits required

Intervention Phase

Participants consume NOURISH meals to assess impact on glycemic control

1 week

NOURISH meals delivered to pick-up points

Crossover Phase

Participants switch diets to compare glycemic responses

1 week

NOURISH meals delivered to pick-up points

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• NOURISH's Culturally Modified Meals

Trial Overview

The study aims to compare the effects of participants' self-selected diets versus specially tailored meals that align with their cultural preferences while adhering to American Diabetes Association guidelines on blood sugar control.

How Is the Trial Designed?

Group I: Self Selected Diet to NOURISH Diet Experimental Treatment 2 Interventions

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.

Group II: NOURISH Diet to Self-Selected Diet Experimental Treatment 2 Interventions

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 Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Tastermonial Inc

Industry Sponsor

Trials

2

Recruited

60+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A 6-month study involving 114 Northern Plains Indians with type 2 diabetes showed that those receiving culturally adapted nutrition education based on the Medicine Wheel Model experienced significant weight loss and decreased BMI compared to a usual care group.

Despite the positive changes in weight and BMI, the intervention did not lead to significant improvements in blood glucose or lipid levels, suggesting that longer and more frequent educational support may be necessary for better metabolic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Medicine Wheel nutrition intervention: a diabetes education study with the Cheyenne River Sioux Tribe. Kattelmann, KK., Conti, K., Ren, C.[2010]

Nutrition interventions for Chinese populations with type 2 diabetes, both in China and as immigrants, often follow intensive lifestyle programs and show improvements in blood glucose control, indicating their efficacy.

Cultural adaptation of these interventions is crucial for success, particularly in Western countries, yet there is a need for more community-based trials and better documentation of dietary behaviors to fully understand their impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Interventions for Type 2 Diabetes in Chinese Populations: A Scoping Review. Deng, F., Zhang, A., Chan, C.[2020]

A 6-month study involving 114 Northern Plains Indians with type 2 diabetes showed that those receiving culturally adapted nutrition education based on the Medicine Wheel Model experienced significant weight loss and decreased BMI compared to a usual care group.

While the intervention led to positive changes in weight, it did not significantly impact blood glucose or lipid levels, suggesting that more frequent and longer educational support may be necessary for better metabolic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The medicine wheel nutrition intervention: a diabetes education study with the Cheyenne River Sioux Tribe. Kattelmann, KK., Conti, K., Ren, C.[2021]

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