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?

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.

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

Are You a Good Fit for This Trial?

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

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+