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Plant-based diet compared with usual care for painful nerve damage in type 2 diabetes

Compares a plant-based diet with usual medicines for painful diabetic nerve damage.

Key facts

Who runs it
AdventHealth
Where
Hendersonville, United StatesSee the site
Trial code
Registry title
The Treatment of Painful Diabetic Neuropathy With Diet
Status
Recruiting
People taking part
40 people, planned
Started
23 Apr 2024
Expected to end
28 Feb 2028
Type of study
Interventional, 2 groups
Treatments tested
  • Diet
  • Medical management
Record updated
30 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes or pre-diabetes who have painful nerve damage in the limbs, confirmed by a nerve test. It compares a plant-based diet with standard medicines for the pain.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Type 2 diabetes (HgA1c 6.5 or higher) or pre-diabetes (HgA1c 5.7-6.4). Painful nerve damage (neuropathy) shown on EMG/NCS nerve testing (sural-to-radial amplitude ratio of 0.21 or less). Pain rated 4 or more out of 10, plus reduced sensation.
Biomarker or test result
HgA1c 6.5 or higher for type 2 diabetes, or 5.7-6.4 for pre-diabetes. EMG/NCS sural-to-radial amplitude ratio of 0.21 or less.

Main reasons for not taking part

  • Another possible cause of neuropathy besides type 2 diabetes
  • Type 1 diabetes
  • Vitamin B12 or folate deficiency, or other nutritional deficiencies
  • Thyroid problems, autoimmune or inflammatory disorders
  • HIV/AIDS, multiple myeloma, or exposure to metals or toxins

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in United States

  • AdventHealth HendersonvilleHendersonville, United StatesContact: Mary Stanford, Clinical Research CoordinatorTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The 2 groups in the trial

  • Diet armTreatment being tested

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

    Treatment: Diet

  • medical managmentTreatment being tested

    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.

    Treatment: Medical management

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Treatment of Painful Diabetic Neuropathy With Diet, a Randomized-controlled Trial
Plain-language title
Plant-based diet compared with usual care for painful nerve damage in type 2 diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
30 April 2026