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 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 galvanic skin response, as measured by Sudoscan technology. Galvanic skin response detects sweat gland function, which is an indicator of small nerve fiber function..
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.