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Diet vs. drugs: Plant-Based eating tested for diabetic nerve pain

NCT ID NCT07509671

Symptom relief Sponsor: AdventHealth Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a whole-food, plant-based diet (no added oils) can reduce painful diabetic neuropathy better than standard medication. Forty adults with type 2 diabetes and nerve pain will be randomly assigned to either the diet or medication optimization. The main goal is to see if pain scores improve over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Plant-based diet (whole-food, no added oils)
What this could lead to
If it works, this could offer a drug-free way to reduce nerve pain in people with type 2 diabetes.
What could go wrong
This is a small, early-stage trial with only 40 participants. Diet changes can be hard to stick with, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetes mellitus diabetic neuropathy Pain peripheral nervous system disorder type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Painful diabetic neuropathy (PDN) Peripheral neuropathy with type 2 diabetes Vegan diet

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth Hendersonville

    RECRUITING

    Hendersonville, North Carolina, 28759, United States

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