Diet to reduce pain from diabetic peripheral neuropathy
Official title: The Treatment of Painful Diabetic Neuropathy With Diet, a Randomized-controlled Trial
Run by AdventHealth · NCT07509671 · Data updated 2026-11-12
This compares a whole-food, plant-based, no-added-oil diet with usual medications to see if it lowers pain and improves nerve symptoms in adults with painful diabetic neuropathy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | AdventHealth Academic / other |
| Locations | 1 site (Hendersonville, North Carolina) |
| Status | Recruiting |
| Started | April 23, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | February 28, 2028 |
| Registry record updated | April 30, 2026 |
| Trial ID | NCT07509671 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with type 2 diabetes or prediabetes, objective EMG/NCS confirmation of peripheral neuropathy, and painful neuropathy with pain ≥4/10 who can consent and attend follow-up visits are ideal candidates.
✕Probably not a fit
Patients with non-diabetic causes of neuropathy (for example B12 or folate deficiency, thyroid disease, autoimmune or inflammatory disorders, HIV, toxin exposure, multiple myeloma, or significant lumbar stenosis), type 1 diabetes, or those unable to follow a strict plant-based oil-free diet may not receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective randomized controlled study comparing a whole-food, plant-based diet excluding all animal products and added oils to optimized pharmacologic management over a two-month period. Participants in the diet group will eliminate meat, dairy, eggs, and added oils and will be offered an optional cooking class to support adherence. The control group will receive optimized medications (e.g., gabapentin, pregabalin, duloxetine, tricyclic antidepressants, or supplements like alpha-lipoic acid) with the option to cross over to the diet after two months. Inclusion requires type 2 diabetes or prediabetes, objective EMG/NCS evidence of peripheral neuropathy, and pain rated ≥4/10; the study is conducted without external funding.
Why it matters
Potential benefit: If successful, the diet could reduce neuropathic pain, improve nerve blood flow and function, and decrease reliance on pain medications.
How similar studies have gone: A prior case series reported improvement in painful diabetic neuropathy with this diet and other research shows whole-food, plant-based diets can improve arterial disease, but randomized trials specific to PDN are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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AdventHealth Hendersonville
Hendersonville, North Carolina, United States Recruiting
Study contacts
- Study coordinator: William J Beckworth, MD
- Email: william.beckworth.md@adventhealth.com
- Phone: 828-654-8546
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.