The Treatment of Painful Diabetic Neuropathy With Diet

NCT07509671 | Recruiting

• 1 other identifier: 2102531
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Painful Diabetic Neuropathy (PDN); Vegan Diet; Peripheral Neuropathy With Type 2 Diabetes

Keywords

painful; diabetic; neuropathy; peripheral neuropathy; diabetes; diabetes type 2

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (16)

• Worst Pain Score on Numerical Rating Scale (NRS)

  2 months

• Numbness location

  2 months

• Sleep

  2 months

• Diabetes medication

  2 months

• Pain medication

  2 months

Study Arms (2)

Diet arm

EXPERIMENTAL

This is a whole food plant-based diet that excludes meat, dairy, eggs and oil

Other: Diet

medical managment

EXPERIMENTAL

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

Interventions

Diet OTHER

Plant-based diet

Also known as: Plant-based diet

Diet arm

Medical management OTHER

Medication optimization

medical managment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

AdventHealth Hendersonville

Hendersonville, North Carolina, 28759, United States

RECRUITING

Related Publications (4)

• 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

  BACKGROUND

• 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.

  PMID: 39415400 BACKGROUND

• 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.

  PMID: 26011582 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies; Pain; Peripheral Nervous System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Diet; Diet, Plant-Based; Practice Management, Medical

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics; Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Central Study Contacts

William J Beckworth, MD

CONTACT

828-654-8546; william.beckworth.md@adventhealth.com

Mary Stanford, Clinical Research Coordinator

CONTACT

828-654-8546; mary.stanford@adventhealth.com

Study Design

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

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: April 3, 2026
• Study Start: April 23, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: From start to finish. Anticipated finish date for data collection is December 2027 and publication by mid 2028
• 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.

Locations

US (1)