Low-Fat Vegan Diet for Type 2 Diabetes

Overseen By Macy Sutton, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Physicians Committee for Responsible Medicine

Disqualifiers: Type 1 diabetes, Smoking, Alcohol abuse, Cancer, others

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

Compensation: Varies

Number of Visits: 20

Duration: 16 weeks

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial involves online nutrition classes and a low-fat, vegan diet for Blue Cross Blue Shield subscribers with type 2 diabetes. The goal is to see if these changes can improve their health and reduce healthcare costs by teaching them about healthy eating and following a specific diet.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study coordinators or your healthcare provider.

Is a low-fat vegan diet safe for humans?

Research suggests that a low-fat vegan diet is generally safe for humans, as it can improve diabetes management and reduce cardiovascular risk factors without significant safety concerns. ^{1 2 3 4 5}

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 minimizes fat intake, unlike other diets that may include animal products or higher fat content. This approach may improve diabetes management by enhancing glycemic and lipid control without requiring additional lifestyle changes like exercise. ^{4 5 6 7 8}

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 diabetes management by reducing weight, blood sugar levels, and bad cholesterol more effectively than other eating plans. Additionally, it helps improve blood sugar control and heart health in people with type 2 diabetes. ^{1 2 4 5 9}

Who Is on the Research Team?

Neal Barnard, MD

Principal Investigator

Physicians Committee for Responsible Medicine

Are You a Good Fit for This Trial?

Adults over 18 with type 2 diabetes, who are Blue Cross Blue Shield subscribers and have been so for the past year. Participants must be willing to adopt a plant-based diet, attend weekly online classes for 16 weeks, and keep their physical activity level steady.

Inclusion Criteria

I can attend weekly online classes for the first 16 weeks.

You cannot follow a plant-based diet for the first 16 weeks of the study.

I am either male or female.

Exclusion Criteria

Recently gave birth, pregnant, or plans to become pregnant before or during the study period

I have been diagnosed with cancer.

Institutional custodial care

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend weekly online classes on nutrition and health and follow a low-fat, vegan diet

16 weeks

16 visits (virtual)

Follow-up

Participants' medical utilization, plasma lipids, and HbA1C are monitored every 6 months

2 years

4 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Low-fat, vegan diet

Trial Overview The CARING study is testing the effects of a low-fat vegan diet on health outcomes in individuals with type 2 diabetes. It includes nutrition education and aims to evaluate potential healthcare cost savings.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

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

Group II: Control Group Active Control 1 Intervention

The Control group arm of participants will be asked to maintain their regular, pre-study diet.

Who Is Running the Clinical Trial?

Physicians Committee for Responsible Medicine

Lead Sponsor

Trials

30

Recruited

2,600+

Blue Cross Blue Shield

Collaborator

Trials

24

Recruited

273,000+

Published Research Related to This Trial

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]

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]

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 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]

Only 9% of patients with type 2 diabetes currently follow a plant-based diet, but 66% expressed willingness to try it for 3 weeks, indicating a potential for increased adoption with proper education.

While 72% of healthcare providers are aware of the benefits of plant-based diets for diabetes management, their low levels of practice suggest a need for educational interventions to improve both patient and provider knowledge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness and perception of plant-based diets for the treatment and management of type 2 diabetes in a community education clinic: a pilot study. Lee, V., McKay, T., Ardern, CI.[2020]

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]

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]

Weight loss is crucial for managing type 2 diabetes, but there is no single best diet strategy, as various approaches like low-carb, low glycemic-index, and high-protein diets have shown mixed results.

The most effective weight-loss strategy is the one that patients can consistently follow over the long term, highlighting the importance of individual adherence to dietary plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional strategies in type 2 diabetes mellitus. Davis, N., Forbes, B., Wylie-Rosett, J.[2009]

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]

Citations

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

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]

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

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

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

Awareness and perception of plant-based diets for the treatment and management of type 2 diabetes in a community education clinic: a pilot study. [2020]

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

Nutritional strategies in type 2 diabetes mellitus. [2009]

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

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