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.
The primary objective of this study is to determine whether dietary modification can improve symptoms of painful diabetic neuropathy (PDN) in a randomized controlled trial. This will be a prospective, randomized controlled study comparing a dietary intervention with conventional medical management over a two-month period. Participants assigned to the conventional management group will have the option to cross over to the dietary intervention after two months, with additional outcomes assessed following crossover. The dietary intervention is based on a prior case series demonstrating improvement in PDN with a whole-food, plant-based diet excluding all animal products and added oils. Participants will eliminate meat (red and white), dairy, eggs, and added oils. Those in the dietary group will also be encouraged to attend an optional cooking class to support adherence. Conventional medical management will consist of optimized pharmacologic therapy, including antiepileptic agents (gabapentin or pregabalin), serotonin-norepinephrine reuptake inhibitors (e.g., duloxetine), tricyclic antidepressants, and over-the-counter options such as alpha-lipoic acid. Medications will be titrated to maximize pain relief while minimizing adverse effects. This study will be conducted without external funding.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Plant-based diet
Medication optimization
AdventHealth Hendersonville
Hendersonville, North Carolina, United States
RECRUITINGNumerical Rating Scale (NRS)
Numerical Rating Scale (NRS) is a 0-10 pain score with 0 being no pain and 10 being the worst pain ever.
Time frame: 2 months
Average pain on Numerical Rating Scale (NRS)
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.
Time frame: 2 months
≥50% improvement of pain
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.
Time frame: 2 months
≥75% improvement of pain
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.
Time frame: 2 months
Worst Pain Score on Numerical Rating Scale (NRS)
Patient will be asked what his or her worst pain is on a daily basis using the Numerical Rating Scale (NRS) for pain where 0 is no pain and 10 is the worst pain ever.
Time frame: 2 months
Numbness location
Patient asked the following: How far up does your numbness go in both lower extremities: (circle one): 1. Toes 2. Mid foot 3. Entire foot 4. Ankle 5. Mid calf 6. Knee
Time frame: 2 months
Sleep
Patient is asked the following questions. How is your sleep? Circle one: good moderate poor 1. How many hours are you sleeping a night? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 2. Is your sleep improved since the start of study? \_\_\_\_\_\_\_\_\_\_\_\_\_\_ (yes or no)
Time frame: 2 months
Diabetes medication
Patient is asked: List your diabetes medications and doses.
Time frame: 2 months
Pain medication
Patient is asked the following question. List your pain medications and doses.
Time frame: 2 months
% pain improvement
Patient is asked: What percentage of has your pain improved compared to the start of the study? \_\_\_\_\_\_\_\_\_\_\_\_ (0% = no change to 100% complete relief of pain)
Time frame: 2 months
% numbness improvement
What percent is your numbness improved compared to baseline? (0% = no improvement, 100% complete improvement)
Time frame: 2 months
Increased function
Have you been able to increase your function (walking, getting around, steadiness on feet)? \_\_\_\_\_\_\_\_\_ (yes or no)
Time frame: 2 months
Compliance with diet
If you are in the diet group, how compliant have you been with your diet? Chose one: 1. 0% (not compliant at all) 2. 25% 3. 50% 4. 75% 5. 90% 6. 100% (completely compliant at all times)
Time frame: 2 months
Global impression of change
Rate your global impression of change of your diabetic neuropathy (chose one): 1. Very much improved 2. Much improved 3. Moderately improved 4. Minimally improved 5. No change 6. Worse 7. Much worse 8. Very much worse
Time frame: 2 months
Weight
Weight in pounds measured at baseline and two months. This is measured in clinic.
Time frame: 2 months
Blood pressure
Number of participants with abnormal blood pressure based off the 2017 American College of Cardiology / American Heart Association Guidelines.
Time frame: 2 months
Heart Rate
Number of participants with abnormal heart rate (outside of normal 60-100/min)
Time frame: 2 months
Creatinine lab level
Number of participants with abnormal creatinine lab level (above 1.3 for males, 1.1 for females) and correlating with estimated glomerular filtration rate which is based off creatinine, age and sex. Kidney function will be based on the National Kidney Foundation guidelines (KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease).
Time frame: 2 months
Lipid levels
Percentage of patients with abnormal lipid levels based on the American Heart Association's cholesterol guidelines and lipid reference values.
Time frame: 2 months
Hemoglobin A1c
Percent of patients with abnormal hemoglobin A1c. Abormal values are based on American Diabetes Association (normal \<5.7, pre-diabetes 5.7-6.4, diabetes ≥6.5).
Time frame: 2 months
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