← Back to Search

Behavioural Intervention

Vegan diet and vitamin B12 supplement for Diabetic Neuropathy

N/A
Waitlist Available
Led By Neal Barnard, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Awards & highlights
No Placebo-Only Group

Summary

The purpose of this study is to assess whether, in individuals with diabetic neuropathy, a low-fat, vegan diet in combination with a vitamin B12 supplement improves pain, sensation and other subjective symptoms, more effectively than a vitamin B12 supplement with no diet changes. The principal measure is pain as measured by the following assessment tools: Michigan Neuropathy Screening Instrument, Norfolk Quality of Life Questionnaire, Neuropathy Impairment Score - Lower Limbs, Neuropathy Total Symptom Score, Neuropathy Pain Scale, McGill Pain Questionnaire and Global Impression Scale. The study duration is 20 weeks. This study also examines the effects of a low-fat, vegan diet on mood, using the Center for Epidemiologic Studies Depression Scale-Revised, and the Beck Depression Inventory.

Eligible Conditions
  • Diabetic Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease activity
Glycemic control
Mood
+2 more
Secondary study objectives
Quality of life
Other study objectives
Acceptability of vegan diet

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Vegan diet and vitamin B12 supplementExperimental Treatment1 Intervention
The diet/supplement group will be asked to follow a low-fat, vegan diet for 20 weeks, and take a vitamin B12 supplement daily.
Group II: Vitamin B12 supplementActive Control1 Intervention
The supplement group will be asked to take a daily vitamin B12 supplement, and to make no changes to their current diet.

Find a Location

Who is running the clinical trial?

Physicians Committee for Responsible MedicineLead Sponsor
29 Previous Clinical Trials
2,610 Total Patients Enrolled
Neal Barnard, MDPrincipal InvestigatorPhysicians Committee for Responsible Medicine
9 Previous Clinical Trials
1,278 Total Patients Enrolled
~1 spots leftby Nov 2025