The Treatment of Painful Diabetic Neuropathy With Diet

The Treatment of Painful Diabetic Neuropathy With Diet, a Randomized-controlled Trial

The purpose of this clinical trial is to determine whether targeted nutritional changes can improve symptoms of painful diabetic neuropathy. Impaired blood flow to peripheral nerves-resulting in reduced oxygen delivery and subsequent nerve injury-is a well-established contributor to neuropathy. Prior studies have shown that a whole-food, plant-based diet without added oils can improve or even reverse arterial disease, suggesting a potential mechanism for enhancing nerve perfusion and function.

This study is a randomized controlled trial comparing a whole-food, plant-based diet with standard pharmacologic management for painful diabetic neuropathy.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Neuropathy With Type 2 Diabetes; Painful Diabetic Neuropathy (PDN); Vegan Diet
• Intervention / Treatment: Other: Diet; Other: Medical management

Detailed Description

The primary objective of this study is to determine whether dietary modification can improve symptoms of painful diabetic neuropathy (PDN) in a randomized controlled trial.

This will be a prospective, randomized controlled study comparing a dietary intervention with conventional medical management over a two-month period. Participants assigned to the conventional management group will have the option to cross over to the dietary intervention after two months, with additional outcomes assessed following crossover.

The dietary intervention is based on a prior case series demonstrating improvement in PDN with a whole-food, plant-based diet excluding all animal products and added oils. Participants will eliminate meat (red and white), dairy, eggs, and added oils. Those in the dietary group will also be encouraged to attend an optional cooking class to support adherence.

Conventional medical management will consist of optimized pharmacologic therapy, including antiepileptic agents (gabapentin or pregabalin), serotonin-norepinephrine reuptake inhibitors (e.g., duloxetine), tricyclic antidepressants, and over-the-counter options such as alpha-lipoic acid. Medications will be titrated to maximize pain relief while minimizing adverse effects.

This study will be conducted without external funding.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: William J Beckworth, MD; Phone Number: 828-654-8546; Email: william.beckworth.md@adventhealth.com
• Study Contact Backup: Name: Mary Stanford, Clinical Research Coordinator; Phone Number: 828-654-8546; Email: mary.stanford@adventhealth.com

Study Locations

• United States
  • North Carolina
    • Hendersonville, North Carolina, United States, 28759
      • Recruiting
      • AdventHealth Hendersonville
      • Contact: Mary Stanford, Clinical Research Coordinator; Phone Number: 828-654-8546; Email: mary.stanford@adventhealth.com
      • Principal Investigator: William J Beckworth, MD
      • Sub-Investigator: Sven Jonsson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Definitive diagnosis of type II diabetes mellitus (HgA1c ≥ 6.5) or pre-diabetes (HgA1c 5.7-6.4)
• objective documentation of peripheral neuropathy on EMG/NCS testing defined as a sural-to-radial amplitude ratio of 0.21 or less
• presence of painful neuropathy in addition to decreased sensation
• with pain rated ≥4/10 on a 0-10 numerical rating scale (NRS)
• age 18 years or older
• ability to provide informed consent
• ability to attend follow-up visits.

Exclusion Criteria:

• Potential causes of neuropathy other than type II diabetes mellitus (as listed below)
• type I diabetes
• vitamin B12 deficiency
• folate deficiency
• thyroid dysfunction,
• other nutritional deficiencies
• autoimmune disorders
• inflammatory disorders
• HIV/AIDS
• exposure to metals or toxins
• multiple myeloma,
• moderate to severe lumbar stenosis with neurogenic claudication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diet arm; This is a whole food plant-based diet that excludes meat, dairy, eggs and oil	Other: Diet; Plant-based diet; Other Names: Plant-based diet
Experimental: medical managment; This approach reflects standard pharmacologic management of diabetic peripheral neuropathy. Commonly used medications include antiepileptic agents (gabapentin, pregabalin), serotonin-norepinephrine reuptake inhibitors (e.g., duloxetine), tricyclic antidepressants (e.g., amitriptyline, nortriptyline), and over-the-counter options such as alpha-lipoic acid and turmeric.	Other: Medical management; Medication optimization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale (NRS)	Numerical Rating Scale (NRS) is a 0-10 pain score with 0 being no pain and 10 being the worst pain ever.	2 months
Average pain on Numerical Rating Scale (NRS)	Patient will be asked what his or her "average" pain has been over the last 3 days. This will be on the Numerical Rating Scale (NRS) for pain where 0 is no pain and 10 is the worst pain ever.	2 months
≥50% improvement of pain	Patient will be asked if his or her average pain over the past 3 days is ≥50% better than baseline pain. This will be comparing the Numerical Rating Scale (NRS) for pain where 0 is no pain and 10 is the worst pain ever.	2 months
≥75% improvement of pain	Patient will be asked if his or her average pain over the past 3 days is ≥75% better than baseline pain. This will be comparing the Numerical Rating Scale (NRS) for pain where 0 is no pain and 10 is the worst pain ever.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Worst Pain Score on Numerical Rating Scale (NRS)	Patient will be asked what his or her worst pain is on a daily basis using the Numerical Rating Scale (NRS) for pain where 0 is no pain and 10 is the worst pain ever.	2 months
Numbness location	Patient asked the following: How far up does your numbness go in both lower extremities: (circle one): Toes; Mid foot; Entire foot; Ankle; Mid calf; Knee	2 months
Sleep	Patient is asked the following questions. How is your sleep? Circle one: good moderate poor; How many hours are you sleeping a night? ___________________; Is your sleep improved since the start of study? ______________ (yes or no)	2 months
Diabetes medication	Patient is asked: List your diabetes medications and doses.	2 months
Pain medication	Patient is asked the following question. List your pain medications and doses.	2 months
% pain improvement	Patient is asked: What percentage of has your pain improved compared to the start of the study? ____________ (0% = no change to 100% complete relief of pain)	2 months
% numbness improvement	What percent is your numbness improved compared to baseline? (0% = no improvement, 100% complete improvement)	2 months
Increased function	Have you been able to increase your function (walking, getting around, steadiness on feet)? _________ (yes or no)	2 months
Compliance with diet	If you are in the diet group, how compliant have you been with your diet? Chose one: 0% (not compliant at all); 25%; 50%; 75%; 90%; 100% (completely compliant at all times)	2 months
Global impression of change	Rate your global impression of change of your diabetic neuropathy (chose one): Very much improved; Much improved; Moderately improved; Minimally improved; No change; Worse; Much worse; Very much worse	2 months
Weight	Weight in pounds measured at baseline and two months. This is measured in clinic.	2 months
Blood pressure	Number of participants with abnormal blood pressure based off the 2017 American College of Cardiology / American Heart Association Guidelines.	2 months
Heart Rate	Number of participants with abnormal heart rate (outside of normal 60-100/min)	2 months
Creatinine lab level	Number of participants with abnormal creatinine lab level (above 1.3 for males, 1.1 for females) and correlating with estimated glomerular filtration rate which is based off creatinine, age and sex. Kidney function will be based on the National Kidney Foundation guidelines (KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease).	2 months
Lipid levels	Percentage of patients with abnormal lipid levels based on the American Heart Association's cholesterol guidelines and lipid reference values.	2 months
Hemoglobin A1c	Percent of patients with abnormal hemoglobin A1c. Abormal values are based on American Diabetes Association (normal <5.7, pre-diabetes 5.7-6.4, diabetes ≥6.5).	2 months

Collaborators and Investigators

• Sponsor: AdventHealth

Publications and helpful links

General Publications

• Storz MA, Küster O. Plant-based diets and diabetic neuropathy: A systematic review. Lifestyle Med. 2020; 1:e6. https://doi.org/10.1002/lim2.6
• Guest NS, Raj S, Landry MJ, Mangels AR, Pawlak R, Senkus KE, Handu D, Rozga M. Vegetarian and Vegan Dietary Patterns to Treat Adult Type 2 Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Adv Nutr. 2024 Oct;15(10):100294. doi: 10.1016/j.advnut.2024.100294. Epub 2024 Sep 30.
• Bunner AE, Wells CL, Gonzales J, Agarwal U, Bayat E, Barnard ND. A dietary intervention for chronic diabetic neuropathy pain: a randomized controlled pilot study. Nutr Diabetes. 2015 May 26;5(5):e158. doi: 10.1038/nutd.2015.8.
• Crane M, Sample C. Regression of diabetic neuropathy with total vegetarian (vegan) diet. Journal of Nutritional Medicine. 1994;4(4):431-439. https://doi.org/10.3109/13590849409003592.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: diabetes; peripheral neuropathy; neuropathy; diabetes type 2; diabetic; painful
• Additional Relevant MeSH Terms: Neurologic Manifestations; Endocrine System Diseases; Nervous System Diseases; Neuromuscular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Complications; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pain; Diabetes Mellitus, Type 2; Diabetes Mellitus; Peripheral Nervous System Diseases; Diabetic Neuropathies; Professional Practice; Organization and Administration; Health Services Administration; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet Therapy; Nutrition Therapy; Practice Management; Diet; Diet, Plant-Based; Practice Management, Medical
• Other Study ID Numbers: 2102531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication.
• IPD Sharing Time Frame: From start to finish. Anticipated finish date for data collection is December 2027 and publication by mid 2028
• IPD Sharing Access Criteria: Access criteria will be based on those who are involved with the study or have oversight of study. This will include principle investigators, research coordinators, statisticians, IRB, research institute or any monitoring bodies.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No