NCT01050244

The Effect of Soy Protein on Neuropathic Pain

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Dr. Yoram Shir · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Neuralgia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Whole soybean soymilk powder
DIETARY_SUPPLEMENT	Whole milk powder

Timeline

• Start date: 2011-02-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2010-01-15
• Last updated: 2016-03-22

Locations

1 site across 1 country: Canada