Low-fat Vegan Diet for Type 2 Diabetes

Recruiting in Palo Alto (17 mi)

Overseen by Hana Kahleova, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Physicians Committee for Responsible Medicine

Must not be taking: Antidepressants, Antipsychotics, Lithium, others

Disqualifiers: Type 1 diabetes, Insulin, Smoking, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The goal of this 16-week clinical trial is to assess the health benefits of a low-fat vegan diet on insulin sensitivity and glycemic control in type 2 diabetes. Participants will receive at no cost, study-related weekly nutrition education classes and one-on-one consultation with a registered dietitian.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your medications have been stable for the past 3 months. It seems you can continue your current medication regimen as long as it remains stable.

What data supports the effectiveness of the low-fat vegan diet treatment for type 2 diabetes?

Research shows that a low-fat vegan diet can improve blood sugar control and reduce risk factors for heart disease in people with type 2 diabetes. Plant-based diets, which focus on whole grains, vegetables, fruits, and legumes, have been found to help manage diabetes by improving blood sugar levels, body weight, and cholesterol. ^{1 2 3 4 5}

Is a low-fat vegan diet safe for humans?

Research shows that a low-fat vegan diet is generally safe for humans and can improve diabetes management, including better blood sugar control and lower cholesterol levels. ^{1 2 3 4 6}

How does a low-fat vegan diet treatment for type 2 diabetes differ from other treatments?

A low-fat vegan diet for type 2 diabetes is unique because it focuses on plant-based foods and limits fats, which can improve diabetes management by reducing weight, blood sugar levels, and bad cholesterol more effectively than traditional portion-controlled diets. ^{1 2 3 7 8}

Research Team

Hana Kahleova, MD, PhD

Principal Investigator

Physicians Committee for Responsible Medicine

Eligibility Criteria

Adults with type 2 diabetes, BMI of 26-40, stable medication use for the past 3 months, and HbA1c levels between 6.5-10.5% can join this trial. Excluded are those using recreational drugs or smoking recently, pregnant women or those planning pregnancy, individuals with unstable health conditions or eating disorders, non-English speakers, heavy drinkers, and anyone already on a low-fat vegan diet.

Inclusion Criteria

I have type 2 diabetes and am treated with diet or pills, but not sulfonylureas.

My medications for diabetes, high blood pressure, and cholesterol have been the same for the last 3 months.

I am 18 years old or older.

Exclusion Criteria

You have a diagnosed eating disorder.

You are expected to cause trouble during group meetings.

I am willing and able to follow all study requirements.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a low-fat vegan diet and attend weekly online nutrition classes for 16 weeks

16 weeks

16 visits (virtual), 2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Low-fat Vegan Diet (Behavioral Intervention)

Trial Overview This study tests how a low-fat vegan diet affects insulin sensitivity and blood sugar control in type 2 diabetes over a period of 16 weeks. Participants will receive free nutrition education classes and consultations with dietitians to help them follow the dietary plan.

Participant Groups

Group I: Intervention Group: low-fat vegan diet Experimental Treatment 1 Intervention

This arm of participants will be asked to attend weekly online classes in nutrition and health and to follow a low-fat, vegan diet for 16 weeks.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Physicians Committee for Responsible Medicine Washington, United States

Who Is Running the Clinical Trial?

Physicians Committee for Responsible Medicine

Lead Sponsor

Trials

30

Patients Recruited

2,600+

Yale University

Collaborator

Trials

1963

Patients Recruited

3,046,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in nutrient intake and dietary quality among participants with type 2 diabetes following a low-fat vegan diet or a conventional diabetes diet for 22 weeks. Turner-McGrievy, GM., Barnard, ND., Cohen, J., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-carbohydrate vegan diets in diabetes for weight loss and sustainability: a randomized controlled trial. Jenkins, DJ., Jones, PJ., Abdullah, MM., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Turning the Waiting Room into a Classroom: Weekly Classes Using a Vegan or a Portion-Controlled Eating Plan Improve Diabetes Control in a Randomized Translational Study. Barnard, ND., Levin, SM., Gloede, L., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Barnard, ND., Cohen, J., Jenkins, DJ., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspective: Plant-Based Eating Pattern for Type 2 Diabetes Prevention and Treatment: Efficacy, Mechanisms, and Practical Considerations. Jardine, MA., Kahleova, H., Levin, SM., et al.[2023]

Plant-based nutrition education is an effective intervention for managing type 2 diabetes, helping to improve glycemic control and reduce body weight.

A low-fat, plant-based diet is not only well-accepted by patients but also beneficial for reducing cardiac risk, making it a comprehensive approach for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A plant-based diet for type 2 diabetes: scientific support and practical strategies. Trapp, C., Barnard, N., Katcher, H.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diabetic diet 2000]. Kappeler, H.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward improved management of NIDDM: A randomized, controlled, pilot intervention using a lowfat, vegetarian diet. Nicholson, AS., Sklar, M., Barnard, ND., et al.[2022]

References

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

Changes in nutrient intake and dietary quality among participants with type 2 diabetes following a low-fat vegan diet or a conventional diabetes diet for 22 weeks. [2022]

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

Low-carbohydrate vegan diets in diabetes for weight loss and sustainability: a randomized controlled trial. [2023]

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

Turning the Waiting Room into a Classroom: Weekly Classes Using a Vegan or a Portion-Controlled Eating Plan Improve Diabetes Control in a Randomized Translational Study. [2022]

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

A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. [2022]

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

Perspective: Plant-Based Eating Pattern for Type 2 Diabetes Prevention and Treatment: Efficacy, Mechanisms, and Practical Considerations. [2023]

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

A plant-based diet for type 2 diabetes: scientific support and practical strategies. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

[Diabetic diet 2000]. [2015]

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

Toward improved management of NIDDM: A randomized, controlled, pilot intervention using a lowfat, vegetarian diet. [2022]