A Nutritional Intervention for Diabetic Neuropathy (WCCR-DN2)

NCT01953757 | Completed DMC

• 1 other identifier: PCRM DN-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathy

Keywords

diabetic neuropathy, diet, vegan, vegetarian

Outcome Measures

Primary Outcomes (1)

• Pain

  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

  20 weeks

Secondary Outcomes (5)

• Sensation

  20 Weeks

• Disease activity

  20 Weeks

• Glycemic control

  20 Weeks

• Mood

  20 Weeks

• Quality of life

  20 Weeks

Other Outcomes (1)

• Acceptability of vegan diet

  20 Weeks

Study Arms (2)

Vegan diet and vitamin B12 supplement

EXPERIMENTAL

The diet/supplement group will be asked to follow a low-fat, vegan diet for 20 weeks, and take a vitamin B12 supplement daily.

Other: Vegan diet and vitamin B12 supplement

Vitamin B12 supplement

ACTIVE COMPARATOR

The supplement group will be asked to take a daily vitamin B12 supplement, and to make no changes to their current diet.

Dietary Supplement: Vitamin B12 supplement

Interventions

Vegan diet and vitamin B12 supplement OTHER

A low-fat, vegan diet (no meat, fish, eggs or dairy products) and a vitamin B12 supplement in the form of 2000mcg of methylcobalamin

Also known as: Vegan diet

Vegan diet and vitamin B12 supplement

Vitamin B12 supplement DIETARY_SUPPLEMENT

A daily vitamin B12 supplement in the form of 2000mcg of methylcobalamin

Also known as: B12

Vitamin B12 supplement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age 18 - 65 years old
• A diagnosis of type 2 diabetes
• A diagnosis of diabetic neuropathy for at least 6 months or symptoms of diabetic neuropathy for at least 6 months
• Score of greater than 2 on the Michigan Neuropathy Screening Instrument
• Score of greater than 6on the Norfolk Quality of Life Questionnaire
• Score of greater than 2 on the Neuropathy Impairment Score for Lower Limbs (NIS-LL)
• Score of greater than 1 on the Neuropathy Total Symptom Score 6 (NTSS-6)

You may not qualify if:

• Vitamin B12 deficiency
• Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
• Pregnancy
• Unstable medical or psychiatric illness
• Likely to be disruptive in group sessions (as determined by research staff)
• Already following a low-fat, vegan diet
• Lack of English fluency
• Inability to maintain current medication regimen
• Inability or unwillingness to participate in all components of the study
• Sensitivity to lidocaine or epinephrine (or their preservatives)

Sponsors & Collaborators

• Physicians Committee for Responsible Medicine: lead

Study Sites (1)

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Diet, Vegan; Vitamin B 12

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Neal Barnard, MD

  Physicians Committee for Responsible Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 1, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 27, 2015

Record last verified: 2015-04

Locations

US (1)