Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Nutritional Intervention for Diabetic Neuropathy (WCCR-DN2)
Brief 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.