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Dietary Treatment for Painful Diabetic Neuropathy

This study is looking at whether a plant-based diet can help reduce pain for people with painful diabetic neuropathy (nerve damage from diabetes). Researchers believe that improving blood flow to nerves through diet might help. You could be eligible if you have type 2 diabetes or pre-diabetes, have nerve damage confirmed by a specific test (EMG/NCS), and experience painful neuropathy with a pain rating of 4 or higher out of 10. The study will compare a plant-based diet to standard medical care, which includes medications like gabapentin, pregabalin, duloxetine, and alpha-lipoic acid. The main goal is to see if your pain improves by at least 50% after two months, as measured by a pain scale.

Study design
This is a randomized controlled study with 40 participants, comparing a plant-based diet to standard medical management over two months.
What's involved
Participants will follow either a plant-based diet or receive optimized medical management for two months. Those in the diet group may attend an optional cooking class.
Compensation
Not stated in the trial record.
Follow-up
Pain levels will be measured at two months. Participants in the conventional management group can cross over to the dietary intervention after two months, with additional outcomes assessed after that.

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NCT07509671

The Treatment of Painful Diabetic Neuropathy With Diet

Recruiting
NAAges 18+InterventionalTreatment
AdventHealth
~40 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:DietMedical management

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Numerical Rating Scale (NRS)
Measured over 2 months
+3 more outcomes measured

Conditions

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

Explore related trials

Peripheral NeuropathyType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
North Carolina1

Who to contact

William J Beckworth, MD
[email protected]
828-654-8546
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Numerical Rating Scale (NRS)2 months

    Numerical Rating Scale (NRS) is a 0-10 pain score with 0 being no pain and 10 being the worst pain ever.

  • Average pain on Numerical Rating Scale (NRS)2 months

    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.

  • ≥50% improvement of pain2 months

    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.

  • ≥75% improvement of pain2 months

    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.