40 Participants NeededMy employer runs this trial

Diet for Diabetic Neuropathy

WJ
MS
Overseen ByMary Stanford, Clinical Research Coordinator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: AdventHealth
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a whole-food, plant-based diet can relieve symptoms of painful diabetic neuropathy, a condition where diabetes-related nerve damage causes pain and reduced sensation. It compares this diet to common medications used for the condition. Individuals diagnosed with type II diabetes or pre-diabetes who experience painful neuropathy may be suitable candidates. Participants must have their condition confirmed through specific medical tests and currently rate their pain at a level of 4 out of 10 or higher. As an unphased trial, this study offers a unique opportunity to investigate innovative dietary approaches for managing neuropathy symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It compares a plant-based diet with standard medication, so you might continue your current treatment, but it's best to confirm with the trial organizers.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that a diet focused on whole, plant-based foods effectively managed nerve pain in people with diabetes. This diet also improved blood sugar levels and supported weight loss, which are important for overall health. Importantly, there were no major reports of negative effects, making it a generally safe choice for many. Another study showed that this type of diet reduced pain from diabetic nerve damage without causing significant side effects.

For standard medication treatment, commonly used drugs like gabapentin and duloxetine are considered safe. However, some patients might experience side effects like dizziness or drowsiness. Overall, existing research has shown that both treatment options in this trial are well-tolerated.12345

Why are researchers excited about this trial?

Unlike the standard treatments for diabetic neuropathy, which typically involve medications like gabapentin or duloxetine, the whole-food, plant-based diet offers a non-pharmacological approach. This diet is unique because it excludes meat, dairy, eggs, and oil, potentially reducing inflammation and improving nerve function without relying on drugs. Researchers are excited about this treatment because it could provide a natural, holistic alternative that minimizes side effects and addresses the root cause of the condition. Additionally, this approach could lead to broader health benefits, such as improved cardiovascular health and weight management, which are crucial for patients with diabetes.

What evidence suggests that this trial's treatments could be effective for diabetic neuropathy?

Research has shown that a whole-food, plant-based diet can help manage nerve pain caused by diabetes. Participants in the diet arm of this trial will follow this diet, which might reduce pain and help control blood sugar levels. In one study, people who followed a plant-based diet reported feeling less pain from diabetic nerve damage. Another study suggested that this diet can improve nerve health by boosting blood flow. Overall, evidence supports the idea that switching to a plant-based diet can be a promising way to ease diabetic nerve pain.12346

Are You a Good Fit for This Trial?

This trial is for adults (18+) with type 2 diabetes or pre-diabetes who have painful diabetic nerve damage confirmed by tests, and pain rated at least 4 out of 10. People with other causes of neuropathy, certain deficiencies, autoimmune diseases, or type 1 diabetes cannot join.

Inclusion Criteria

I have been diagnosed with type 2 diabetes or pre-diabetes.
I have painful nerve damage with pain rated 4 or higher out of 10.
Objective documentation of peripheral neuropathy on EMG/NCS testing defined as a sural-to-radial amplitude ratio of 0.21 or less
See 3 more

Exclusion Criteria

Other nutritional deficiencies
I have a thyroid problem.
Autoimmune disorders
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either a whole-food, plant-based diet or standard pharmacologic management for painful diabetic neuropathy over a two-month period

8 weeks
Weekly visits (in-person or virtual)

Crossover

Participants in the conventional management group have the option to cross over to the dietary intervention after two months

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Whole-Food, Plant-Based Diet

Trial Overview

The study compares a whole-food, plant-based diet without added oils to standard medical treatment for managing painful diabetic neuropathy. Participants are randomly assigned to either the diet group or the usual medication group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: medical managmentExperimental Treatment1 Intervention
Group II: Diet armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials
118
Recruited
31,800+

Citations

The efficacy of a whole foods, plant-based dietary lifestyle ...

A whole food plant-based diet (WFPBD) has been shown to be effective in the management of neuropathic pain due to diabetes, limiting severity and relevant ...

Plant‐based diets and diabetic neuropathy: A systematic ...

These studies suggest that a plant-based diet may alleviate pain in affected patients while significantly improving glycemic control, overweight, and serum ...

The Treatment of Painful Diabetic Neuropathy With Diet

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

New Study Shows a Plant-Based Vegan Diet Improves ...

A plant-based diet reduces the pain of diabetic neuropathy, according to new research published today in Nutrition & Diabetes.

A dietary intervention for chronic diabetic neuropathy pain - PMC

This pilot study suggests the potential value of a plant-based diet intervention, including weekly support classes, for treating painful diabetic neuropathy.

A Systematic Review of Dietary Lifestyle Interventions for ...

The low-fat plant-based diet intervention improved neuropathy and NP outcomes ... whole-food, plant-based diet) [74]. Additionally, given the plentiful and ...