Recruiting

Whole-Food Diet & Pharmacologic Management

Sponsor:

AdventHealth

Code:

NCT07509671

Conditions

Painful Diabetic Neuropathy (PDN)

Peripheral Neuropathy With Type 2 Diabetes

Vegan Diet

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diet

Medical management

Study Details

Brief summary:

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.

Conditions

Painful Diabetic Neuropathy (PDN)

Peripheral Neuropathy With Type 2 Diabetes

Vegan Diet

Study ID

NCT07509671

Start date

Apr 23, 2024

Status verified date

Mar, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Diet arm

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

experimental: medical managment

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.

Interventions

Diet

Plant-based diet

Medical management

Medication optimization

Primary outcome measure

  • Numerical Rating Scale (NRS) [ Time Frame: 2 months ]
  • Average pain on Numerical Rating Scale (NRS) [ Time Frame: 2 months ]
  • ≥50% improvement of pain [ Time Frame: 2 months ]
  • ≥75% improvement of pain [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

William J Beckworth, MD

828-654-8546william.beckworth.md@adventhealth.com

Mary Stanford, Clinical Research Coordinator

828-654-8546mary.stanford@adventhealth.com

Locations

AdventHealth Hendersonville

Recruiting

Hendersonville, North Carolina, United States, 28759

Contacts

Mary Stanford, Clinical Research Coordinator

828-654-8546mary.stanford@adventhealth.com

Principal Investigator:

William J Beckworth, MD

More Information

Sponsor

AdventHealth

Last update posted

Apr 30, 2026

Last verified

Mar, 2026

Keywords

  • painful
  • diabetic
  • neuropathy
  • peripheral neuropathy
  • diabetes
  • diabetes type 2

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AdventHealth on 2026-04-30.