The Effect of Soy Protein on Neuropathic Pain

Study Overview
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Brief Summary
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Neuropathic pain is one form of chronic pain lacking effective pharmacotherapy. Interest in the role of complementary and alternative medicine is growing and diet is at the forefront of the search for alternative treatments for pain. Soy protein is one of the most promising dietary ingredients tested for its pain-relieving properties. Results from animal studies show that soy-enriched diets reduce pain due to nerve injury. The purpose of this study is to determine the effects of soy protein supplementation on facial pain.

Detailed Description
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Neuropathic pain is a complex disorder with mixed results in response to pain medication due to a high degree of variability between patients. To address this issue, we are implementing a unique methodology using a series of N-of-1 or single subject randomized, double blind, controlled studies. With this, we will explore the role of soy protein supplementation in neuropathic pain patients. Each patient will be exposed in 3-week intervals to soy protein and a control, milk protein, in three paired treatment periods for a total of 18 weeks. This method allows for the measurement of treatment efficacy in individual distinct patients and has the potential for immediate and continued medical benefit using a simple and readily available dietary ingredient.

Official Title
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The Effect of Soy Protein on Neuropathic Pain: Randomized N-of-1 Trials

Conditions
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Neuralgia

Intervention / Treatment
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* Dietary Supplement: Whole soybean soymilk powder
* Dietary Supplement: Whole milk powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age ≥ 18 years old Chronic neuropathic pain with tactile allodynia > 6 months Suboptimal pain pharmacotherapy (i.e. additional pain control felt by patient and physician to be necessary) Pain intensity score ≥ 5 on 11-point numerical rating scale (NRS) during 1-week screening period prior to randomization Stable medication use (if any) over 4 weeks before starting the trial. Current medication use will be maintained and no additional pharmacotherapy may be introduced during the trial. Up to date mammogram and gynecological evaluations. Exclusion Criteria: History of significant heart, gastro-intestinal, liver or kidney disease History of alcohol/narcotic abuse or current excessive alcohol consumption History or diagnosis of cancer History of breast tumors, predisposition to breast cancer or a family member with breast cancer History of hormonal or gynaecological disease Current use of hormonal replacement therapy (HRT), except thyroid HRT Pregnant or breastfeeding women Use of any anticoagulant or blood thinner except acetylsalicyclic acid Malabsorption of any kind Diagnosed lactase deficiency; Known allergy to any of the dietary products Known allergy to acetaminophen Daily consumption of soy protein in quantities exceeding 10 g/day Strict vegetarians (i.e. no animal derived dietary sources) Antibiotic use within the last 3 months Any previous psychiatric diagnosis before pain onset Body mass index > 35

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soy Protein<br>30g of soy protein from whole soybean soymilk powder given daily for 3 weeks | Dietary Supplement: Whole soybean soymilk powder<br> <br> * Other names: Code #1386;|
| Placebo Comparator: Milk Protein<br>30g of milk protein from whole milk powder given daily for 3 weeks | Dietary Supplement: Whole milk powder<br> <br> * Other names: Parmalat Code #202006;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity |  | Baseline and 3 times during the last week of every treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Quality |  | Baseline and 3 times during the last week of every treatment period | 
| Dynamic tactile allodynia |  | Baseline and at the end of every treatment period | 
| Area of dynamic allodynia |  | Baseline and at the end of every treatment period | 
| Quality of life |  | Baseline and at the end of every treatment period | 
| Depression |  | Baseline and at the end of every treatment period | 
| Dietary intake |  | Baseline, once a week during the first treatment period, once during the second week of the remaining treatment periods. | 
| Body weight |  | Baseline and at the end of every treatment period | 
| Analgesic medication use |  | Baseline and 3 times during the last week of every treatment period | 
| Adverse events |  | The full 18 weeks until the end of the last treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Soy protein, Milk protein, Neuropathic pain