700 Participants Needed

Low-Fat Vegan Diet for Type 2 Diabetes

DN
TZ
AJ
MS
Overseen ByMacy Sutton, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Physicians Committee for Responsible Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.45678

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.12459

Who Is on the Research Team?

NB

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.
See 4 more

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
See 13 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 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 GroupActive Control1 Intervention
The Control group arm of participants will be asked to maintain their regular, pre-study diet.

Find a Clinic Near You

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

Citations

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]
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]
Low-carbohydrate vegan diets in diabetes for weight loss and sustainability: a randomized controlled trial. [2023]
A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. [2022]
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]
A plant-based diet for type 2 diabetes: scientific support and practical strategies. [2020]
[Diabetic diet 2000]. [2015]
Nutritional strategies in type 2 diabetes mellitus. [2009]
Toward improved management of NIDDM: A randomized, controlled, pilot intervention using a lowfat, vegetarian diet. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security