The Effect of Soy Protein on Neuropathic Pain

Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01050244
• Other study ID #: GEN 09-117
• Status: Terminated
• Phase: Phase 2
• First received: January 14, 2010
• Last updated: March 21, 2016
• Start date: February 2011
• Est. completion date: November 2015

Study information

• Verified date: March 2016
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia

Intervention

Dietary Supplement:
• Whole soybean soymilk powder

• Whole milk powder

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Dr. Yoram Shir	Louise & Alan Edwards Foundation, McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity		Baseline and 3 times during the last week of every treatment period	No
Secondary	Pain Quality		Baseline and 3 times during the last week of every treatment period	No
Secondary	Dynamic tactile allodynia		Baseline and at the end of every treatment period	No
Secondary	Area of dynamic allodynia		Baseline and at the end of every treatment period	No
Secondary	Quality of life		Baseline and at the end of every treatment period	No
Secondary	Depression		Baseline and at the end of every treatment period	No
Secondary	Dietary intake		Baseline, once a week during the first treatment period, once during the second week of the remaining treatment periods.	No
Secondary	Body weight		Baseline and at the end of every treatment period	No
Secondary	Analgesic medication use		Baseline and 3 times during the last week of every treatment period	No
Secondary	Adverse events		The full 18 weeks until the end of the last treatment period	Yes