Low-fat Vegan Diet for Type 2 Diabetes

Recruiting at 1 trial location

Overseen By Arathi Jayaraman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Physicians Committee for Responsible Medicine

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

Disqualifiers: Type 1 diabetes, Insulin, Smoking, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 16 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a low-fat vegan diet (also known as a plant-based diet) can improve insulin sensitivity and blood sugar control in people with type 2 diabetes. Participants will learn about nutrition through weekly online classes and have one-on-one sessions with a registered dietitian. It suits those managing type 2 diabetes with diet or certain medications (excluding insulin or sulfonylureas) and who have maintained stable medication use for the past three months. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on dietary impacts on diabetes management.

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 prior data suggests that this low-fat vegan diet is safe for type 2 diabetes?

Research has shown that a low-fat vegan diet is generally safe for most people. Studies have found that this diet can improve blood sugar and cholesterol levels more effectively than some traditional diabetes diets. Participants in those studies did not report any serious negative effects from following a low-fat vegan diet. Instead, they often experienced benefits such as weight loss and better diabetes management. This diet emphasizes fruits, vegetables, and whole grains while avoiding animal products and high-fat foods. Therefore, many people consider it safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the low-fat vegan diet as a treatment for type 2 diabetes because it offers a natural, lifestyle-based approach. Unlike traditional treatments that often involve medications like metformin or insulin, this diet focuses on plant-based foods low in fat, which can improve insulin sensitivity and potentially lead to better blood sugar control without medication. Additionally, it emphasizes whole foods and regular nutrition education, which could empower individuals to manage their condition more effectively and sustainably.

What evidence suggests that a low-fat vegan diet might be an effective treatment for type 2 diabetes?

Research has shown that a low-fat vegan diet, which participants in this trial will follow, can help manage type 2 diabetes. One study found that this diet improves blood sugar levels and cholesterol more effectively than standard diabetes diets. Another study demonstrated that a low-fat plant-based diet aids in weight loss and enhances insulin sensitivity. Additionally, this diet has proven as effective as some diabetes medications in lowering blood sugar levels. These findings suggest that a low-fat vegan diet could be a strong option for managing type 2 diabetes. ^{1 5 6 7 8}

Who Is on the Research Team?

Hana Kahleova, MD, PhD

Principal Investigator

Physicians Committee for Responsible Medicine

Are You a Good Fit for This Trial?

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.

Your HbA1c level is between 6.5% and 10.5%.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Low-fat Vegan Diet

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Physicians Committee for Responsible Medicine

Lead Sponsor

Trials

30

Recruited

2,600+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

A study involving 164 participants with type 2 diabetes found that both a low-carbohydrate vegan diet and a moderate-carbohydrate vegetarian diet significantly reduced body weight and improved metabolic measures like glycated hemoglobin and blood pressure over 3 months.

The low-carbohydrate vegan diet was associated with a greater reduction in potential greenhouse gas emissions compared to the vegetarian diet, highlighting its ecological benefits alongside health improvements.

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]

In a 22-week study involving 99 participants with type 2 diabetes, those following a low-fat vegan diet showed significant improvements in dietary quality, as indicated by a higher Alternate Healthy Eating Index (AHEI) score, compared to those on the American Diabetes Association recommended diet.

The vegan diet led to increased intakes of beneficial nutrients like fiber, vitamins, and minerals, while both diets resulted in reduced energy and fat intake, suggesting that a vegan diet may enhance nutrient profiles for better diabetes management.

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]

A low-fat vegan diet significantly reduced fasting serum glucose levels by 28% in patients with non-insulin-dependent diabetes (NIDDM) over 12 weeks, compared to a 12% reduction in a conventional low-fat diet group.

Participants on the vegan diet also experienced greater weight loss (7.2 kg) compared to the control group (3.8 kg), and some were able to reduce or discontinue their diabetes medications, indicating potential efficacy of dietary intervention in managing NIDDM.

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]

A plant-based eating pattern, which includes whole grains, vegetables, fruits, and legumes while excluding animal products, is linked to a lower risk of developing type 2 diabetes and is effective in managing the condition.

This diet improves key health markers such as blood glucose levels, body weight, and blood pressure, and it also enhances insulin sensitivity and β-cell function, which are crucial for diabetes management.

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]

A diabetes diet in 2000 recommended that 50% to 60% of total caloric intake should come from carbohydrates, emphasizing the importance of slowly metabolized carbohydrates for better blood sugar control.

For type 2 diabetes patients aiming to lose weight, it is crucial to limit fat intake to no more than 20% of total calories, with a preference for vegetable fats over animal fats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study of 99 individuals with type 2 diabetes over 22 weeks, those on a low-fat vegan diet showed greater improvements in glycemic control, with a significant reduction in HbA1c levels compared to those following the American Diabetes Association guidelines.

Participants on the vegan diet also experienced more substantial weight loss (6.5 kg vs. 3.1 kg) and a greater decrease in LDL cholesterol (21.2% vs. 10.7%), indicating enhanced cardiovascular benefits alongside improved diabetes management.

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]

In a 20-week trial involving 40 participants with type 2 diabetes, both a low-fat vegan eating plan and a portion-controlled eating plan led to significant improvements in body weight, hemoglobin A1c (HbA1c), and LDL cholesterol levels, indicating effective dietary interventions for diabetes management.

Despite the improvements in metabolic markers, there were no significant differences between the two eating plans, suggesting that both approaches can be beneficial for individuals with type 2 diabetes when integrated into a clinical practice.

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2677007/

A low-fat vegan diet and a conventional diabetes ... A low-fat vegan diet appeared to improve glycemia and plasma lipids more than did conventional diabetes diet recommendations.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322004896

Plant-Based Eating Pattern for Type 2 Diabetes Prevention ... The DASH diet was developed to lower blood pressure without medications. The eating pattern emphasizes fruit, vegetables, fat-free/low-fat dairy, whole grains, ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2773291

Effect of a Low-Fat Vegan Diet on Body Weight, Insulin ... Meaning A low-fat plant-based diet is an effective tool for reducing body weight and increasing insulin sensitivity and postprandial metabolism.

4. lifestylemedicine.org lifestylemedicine.org/benefits-plant-based-nutrition-type2-diabetes/

Treatment and prevention of type 2 diabetes Of the randomized controlled trials, one study found that a long-term, low-fat vegan diet intervention was as effective in reducing weight and HbA1c as the ADA ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00276939

Plant-Based Dietary Intervention in Type 2 Diabetes The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8634508/

Perspective: Plant-Based Eating Pattern for Type 2 Diabetes ... The DASH diet was developed to lower blood pressure without medications. The eating pattern emphasizes fruit, vegetables, fat-free/low-fat dairy, whole grains, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523036511

Low-carbohydrate vegan diets in diabetes for weight loss ... The vegetarian diet emphasized fruit, vegetables, and low-fat dairy products, with avoidance of meat and snack foods. Participants were also provided with ...

8. nutritionj.biomedcentral.com nutritionj.biomedcentral.com/articles/10.1186/s12937-023-00877-2

Associations between plant-based dietary patterns and risks ... Similarly, high unsaturated fat and low saturated fat content ... Dietary fats and prevention of type 2 diabetes. Prog Lipid Res. 2009 ...