NCT07509671

The Treatment of Painful Diabetic Neuropathy With Diet

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: AdventHealth · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Diet	Plant-based diet
OTHER	Medical management	Medication optimization

Timeline

• Start date: 2024-04-23
• Primary completion: 2027-12-31
• Completion: 2028-02-28
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States