Low-fat Vegan Diet for Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
12346How 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.
12378Eligibility 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.
+2 more
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.
+13 more
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Intervention Group: low-fat vegan dietExperimental Treatment1 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 NearbySelect from list below to view details:
Physicians Committee for Responsible MedicineWashington, United States
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Who Is Running the Clinical Trial?
Physicians Committee for Responsible MedicineLead Sponsor
Yale UniversityCollaborator
References
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.
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.
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.
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.
Perspective: Plant-Based Eating Pattern for Type 2 Diabetes Prevention and Treatment: Efficacy, Mechanisms, and Practical Considerations. [2023]A plant-based eating pattern is associated with a reduced risk of developing type 2 diabetes and is highly effective in its treatment. Diets that emphasize whole grains, vegetables, fruits, and legumes and exclude animal products improve blood glucose concentrations, body weight, plasma lipid concentrations, and blood pressure and play an important role in reducing the risk of cardiovascular and microvascular complications. This article reviews scientific evidence on the effects of plant-based diets for the prevention and treatment of type 2 diabetes. The mechanisms by which plant-based diets improve body weight, insulin sensitivity, and β-cell function are described. Practical considerations including education, nutrition adequacy, and adjusting medications will enhance the success of patients who have diabetes.
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.
[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.
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.