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.
Name: Vegan diet and vitamin B12 supplement
Name: Vitamin B12 supplement
Description: Pain will be measured follow the baseline and 20 week score using n the following assessment tools: Michigan Neuropathy Screening Instrument Norfolk Quality of Life Questionnaire Neuropathy Impairment Score - Lower Limbs Neuropathy Total Symptom Score 6 Neuropathy Pain Scale McGill Pain Questionnaire Global Impression Scale
Measure: Pain Time: 20 weeksDescription: Sensation will be measured follow the baseline and 20 week score using the following assessment tools: Michigan Neuropathy Screening Instrument Norfolk Quality of Life Questionnaire Neuropathy Impairment Score - Lower Limbs Neuropathy Total Symptom Score 6
Measure: Sensation Time: 20 weeksDescription: Disease activity will be measured by change in small fiber density of lower limbs as measured by skin biospy done at baseline and 20 weeks.
Measure: Disease activity Time: 20 weeksDescription: Glycemic control will be measured by change in hemoglobin A1c percentage points at baseline and 20 weeks.
Measure: Glycemic control Time: 20 weeksDescription: Mood will be measured by change in score using the following assessment tools at baseline and 20 weeks: Beck Depression Inventory Center for Epidemiologic Studies Depression Scale Revised
Measure: Mood Time: 20 weeksDescription: Quality of Life will be measured by change in score using the following assessment tools at baseline and 20 weeks: Norfolk Quality of Life Questionnaire MOS SF-36 Questionnaire
Measure: Quality of life Time: 20 weeksDescription: Acceptability of vegan diet will be measured by change in score at baseline and 20 weeks using the Eating Inventory questionnaire.
Measure: Acceptability of vegan diet Time: 20 weeksAllocation: Randomized
Parallel Assignment
There is one SNP
Studies suggest that the A1 allele of the Taq1A polymorphism (rs1800497), located ≈10 kb downstream of the D2 dopamine receptor (DRD2) gene, may influence dietary behavior and response to treatment.