The Effect of Soy Protein on Neuropathic Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by McGill University Health Center
Sponsor:
Collaborators:
Louise & Alan Edwards Foundation
McGill University
Information provided by (Responsible Party):
Dr. Yoram Shir, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01050244
First received: January 14, 2010
Last updated: April 14, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Neuralgia
Dietary Supplement: Whole soybean soymilk powder
Dietary Supplement: Whole milk powder
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Soy Protein on Neuropathic Pain: Randomized N-of-1 Trials

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Pain Intensity [ Time Frame: Baseline and 3 times during the last week of every treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Quality [ Time Frame: Baseline and 3 times during the last week of every treatment period ] [ Designated as safety issue: No ]
  • Dynamic tactile allodynia [ Time Frame: Baseline and at the end of every treatment period ] [ Designated as safety issue: No ]
  • Area of dynamic allodynia [ Time Frame: Baseline and at the end of every treatment period ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Baseline and at the end of every treatment period ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: Baseline and at the end of every treatment period ] [ Designated as safety issue: No ]
  • Dietary intake [ Time Frame: Baseline, once a week during the first treatment period, once during the second week of the remaining treatment periods. ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: Baseline and at the end of every treatment period ] [ Designated as safety issue: No ]
  • Analgesic medication use [ Time Frame: Baseline and 3 times during the last week of every treatment period ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: The full 18 weeks until the end of the last treatment period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 33
Study Start Date: February 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Soy Protein
30g of soy protein from whole soybean soymilk powder given daily for 3 weeks
Dietary Supplement: Whole soybean soymilk powder
Other Names:
  • Benesoy organic soymilk powder
  • Code #1386
Placebo Comparator: Milk Protein
30g of milk protein from whole milk powder given daily for 3 weeks
Dietary Supplement: Whole milk powder
Other Name: Parmalat Code #202006

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050244

Contacts
Contact: Yoram Shir, MD 514-934-8558 yoram.shir@muhc.mcgill.ca
Contact: Sylvie Toupin 514-934-1934 ext 44348 sylvie.toupin@mail.mcgill.ca

Locations
Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Sylvie Toupin    514-934-1934 ext 44348    sylvie.toupin@mail.mcgill.ca   
Principal Investigator: Yoram Shir, MD         
Sub-Investigator: Alexis Codrington, PhD         
Sub-Investigator: Stephanie Chevalier, PhD         
Sub-Investigator: Mark A Ware, MD         
Sponsors and Collaborators
Dr. Yoram Shir
Louise & Alan Edwards Foundation
McGill University
Investigators
Principal Investigator: Yoram Shir, MD McGill University Health Center
  More Information

No publications provided

Responsible Party: Dr. Yoram Shir, Doctor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01050244     History of Changes
Other Study ID Numbers: GEN 09-117
Study First Received: January 14, 2010
Last Updated: April 14, 2015
Health Authority: Canada: Health Canada

Keywords provided by McGill University Health Center:
Soy protein
Milk protein
Neuropathic pain

Additional relevant MeSH terms:
Neuralgia
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 19, 2015