Culturally Modified Diet for Type 2 Diabetes

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 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.

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.

Is the culturally modified diet for type 2 diabetes safe for humans?

The studies reviewed focus on culturally adapted dietary interventions for Indigenous populations with type 2 diabetes, but they do not report any specific safety concerns related to these interventions. This suggests that the culturally modified diet is generally considered safe for human participants. ^{1 2 3 4 5}

How is the NOURISH's Culturally Modified Meals treatment different from other treatments for type 2 diabetes?

NOURISH's Culturally Modified Meals treatment is unique because it tailors dietary interventions to fit the cultural and traditional food habits of individuals with type 2 diabetes, making it easier for them to manage their condition while respecting their cultural preferences. This approach contrasts with standard treatments that may not consider cultural dietary practices. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment NOURISH's Culturally Modified Meals for Type 2 Diabetes?

Research shows that culturally tailored dietary interventions can improve food habits and diabetes management in various immigrant populations, such as Chinese and North African groups. These interventions often lead to better blood sugar control and increased adherence to dietary guidelines, suggesting that culturally modified meals could be effective for managing Type 2 Diabetes. ^{2 3 6 10 11}

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

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]

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]

Citations

1. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness and Acceptability of a Nutrition Intervention Targeting Chinese Adult Immigrants With Type 2 Diabetes in Canada: A Study Using Mixed Methods Analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Nutrition Interventions for Type 2 Diabetes in Chinese Populations: A Scoping Review. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Outcomes of Culturally Tailored Dietary Intervention in the North African and Bangladeshi Diabetic Patients in Italy. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The medicine wheel nutrition intervention: a diabetes education study with the Cheyenne River Sioux Tribe. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The Medicine Wheel nutrition intervention: a diabetes education study with the Cheyenne River Sioux Tribe. [2010]

6. England pubmed.ncbi.nlm.nih.gov

Cooking for Health: a healthy food budgeting, purchasing, and cooking skills randomized controlled trial to improve diet among American Indians with type 2 diabetes. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Community involvement in design, implementation and evaluation of nutrition interventions to reduce chronic diseases in indigenous populations in the U.S.: a systematic review. [2019]

8. Ireland pubmed.ncbi.nlm.nih.gov

Effects of macronutrient composition of the diet on body fat in indigenous people at high risk of type 2 diabetes. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

Culturally competent dietary education for southern rural African Americans with diabetes. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of food-related interventions for African American women with type 2 diabetes. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Cultural Influences on Dietary Self-Management of Type 2 Diabetes in East Asian Americans: A Mixed-Methods Systematic Review. [2020]