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Behavioral Intervention

Low-fat Vegan Diet for Type 2 Diabetes

N/A
Recruiting
Led By Hana Kahleova, MD, PhD
Research Sponsored by Physicians Committee for Responsible Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women with type 2 diabetes treated by diet and/or oral hypoglycemic agents other than sulfonylureas
Medications (antidiabetic, antihypertensive, and lipid-lowering) have been stable for the past 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16-weeks
Awards & highlights

Study Summary

This trial will assess health benefits of a vegan diet on diabetes by providing weekly nutrition classes & 1-on-1 dietitian consults for free.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not typical for dietary interventions like a low-fat vegan diet to have severe side effects compared to medications or surgeries, participants may experience changes in digestion such as bloating or gas initially as their bodies adjust to the new diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have type 2 diabetes and am treated with diet or pills, but not sulfonylureas.
Select...
My medications for diabetes, high blood pressure, and cholesterol have been the same for the last 3 months.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Advanced Glycation End-products (AGE)
Body Composition
Body Weight
+6 more
Secondary outcome measures
Diet Quality
Food Acceptability
Food Cost

Trial Design

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 Location

Who is running the clinical trial?

Yale UniversityOTHER
1,870 Previous Clinical Trials
2,742,966 Total Patients Enrolled
Physicians Committee for Responsible MedicineLead Sponsor
29 Previous Clinical Trials
2,605 Total Patients Enrolled
Hana Kahleova, MD, PhDPrincipal InvestigatorPhysicians Committee for Responsible Medicine
3 Previous Clinical Trials
215 Total Patients Enrolled
~13 spots leftby Dec 2025