Low-Fat Vegan Diet for Type 2 Diabetes

Recruiting in Palo Alto (17 mi)

Overseen by Neal Barnard, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Physicians Committee for Responsible Medicine

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

No Placebo Group

Trial Summary

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.

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.

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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.

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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.

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Eligibility Criteria

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

Trial Timeline

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)

Participant Groups

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.

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.

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

Blue Cross Blue Shield Collaborator

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] Although vegan diets improve diabetes management, little is known about the nutrient profiles or diet quality of individuals with type 2 diabetes who adopt a vegan diet.

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] In research settings, plant-based (vegan) eating plans improve diabetes management, typically reducing weight, glycemia, and low-density lipoprotein (LDL) cholesterol concentrations to a greater extent than has been shown with portion-controlled eating plans.

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

Low-carbohydrate vegan diets in diabetes for weight loss and sustainability: a randomized controlled trial. [2023] Low-carbohydrate, high animal fat and protein diets have been promoted for weight loss and diabetes treatment. We therefore tested the effect of a low-carbohydrate vegan diet in diabetes as a potentially healthier and more ecologically sustainable low-carbohydrate option.

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] We sought to investigate whether a low-fat vegan diet improves glycemic control and cardiovascular risk factors in individuals with type 2 diabetes.

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] Objective. To assess awareness, barriers, and promoters of plant-based diet use for management of type 2 diabetes (T2D) for the development of an appropriate educational program. Design. Cross-sectional study of patients and healthcare providers. Setting. Regional Diabetes Education Centre in ON, Canada. Participants. n = 98 patients attending the Diabetes Education Centre and n = 25 healthcare providers. Variables Measures. Patient questionnaires addressed demographics, health history, and eating patterns, as well as current knowledge, confidence levels, barriers to, promoters of, and interests in plant-based diets. Staff questionnaires addressed attitudes and current practice with respect to plant-based diets. Analysis. Mean values, frequency counts, and logistic regression (alpha = 0.05). Results. Few respondents (9%) currently followed a plant-based diet, but 66% indicated willingness to follow one for 3 weeks. Family eating preferences and meal planning skills were common barriers to diet change. 72% of healthcare providers reported knowledge of plant-based diets for diabetes management but low levels of practice. Conclusions and Implications. Patient awareness of the benefits of a plant-based diet for the management of diabetes remains suboptimal and may be influenced by perception of diabetes educators and clinicians. Given the reported willingness to try (but low current use of) plant-based diets, educational interventions targeting patient and provider level knowledge are warranted.

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

A plant-based diet for type 2 diabetes: scientific support and practical strategies. [2020] The purpose of this review is to provide educators with the knowledge and tools to utilize plant-based nutrition education as an intervention for type 2 diabetes. Scientific support for the efficacy, acceptability, and nutritional adequacy of a plant-based diet for people with type 2 diabetes is presented, and practical considerations such as medication adjustment and risk of hypoglycemia are reviewed.

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

[Diabetic diet 2000]. [2015] Diabetes diet in the year 2000 consists essentially of carbohydrates. 50% to 60% of the total caloric intake has to be taken in form of carbohydrate. Slowly metabolised forms of carbohydrate should be preferred. Fat and proteins should not exceed more than 20% of the respective total caloric intake. Vegetable fats should be preferred compared to animal fats. Patients with type 2 diabetes who should loose weight have to be extremely careful regarding the fat intake. Insulin-dependent diabetics can correct mistakes in the carbohydrate intake by injecting fast insulins provided that they have in-depth knowledge of the mode of action of insulin and dietary experience.

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

Nutritional strategies in type 2 diabetes mellitus. [2009] Weight loss is a key goal in the management of patients with type 2 diabetes mellitus. There are conflicting weight-loss strategies, including low-carbohydrate diets, low glycemic-index diets, low-fat vegan diets, conventional low-fat diets, and high-protein and high-monounsaturated fat diets. There is no evidence to suggest that 1 nutritional strategy is clearly the best. The most successful strategy is one that the patient can adopt and follow in the long term.

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

Toward improved management of NIDDM: A randomized, controlled, pilot intervention using a lowfat, vegetarian diet. [2022] To investigate whether glycemic and lipid control in patients with non-insulin-dependent diabetes (NIDDM) can be significantly improved using a low-fat, vegetarian (vegan) diet in the absence of recommendations regarding exercise or other lifestyle changes.