The Effect of Soy Protein on Neuropathic Pain

Dr. Yoram Shir

Status and phase

Terminated

Phase 2

Conditions

Neuralgia

Treatments

Dietary Supplement: Whole milk powder

Dietary Supplement: Whole soybean soymilk powder

Study type

Interventional

Funder types

Other

Identifiers

NCT01050244

GEN 09-117

Details and patient eligibility

About

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.

Full description

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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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