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The Effect of Soy Protein on Neuropathic Pain

Primary Purpose

Neuralgia

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Whole soybean soymilk powder
Whole milk powder
Sponsored by
Dr. Yoram Shir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgia focused on measuring Soy protein, Milk protein, Neuropathic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Soy Protein

Milk Protein

Arm Description

30g of soy protein from whole soybean soymilk powder given daily for 3 weeks

30g of milk protein from whole milk powder given daily for 3 weeks

Outcomes

Primary Outcome Measures

Pain Intensity

Secondary Outcome Measures

Pain Quality
Dynamic tactile allodynia
Area of dynamic allodynia
Quality of life
Depression
Dietary intake
Body weight
Analgesic medication use
Adverse events

Full Information

First Posted
January 14, 2010
Last Updated
March 21, 2016
Sponsor
Dr. Yoram Shir
Collaborators
Louise & Alan Edwards Foundation, McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT01050244
Brief Title
The Effect of Soy Protein on Neuropathic Pain
Official Title
The Effect of Soy Protein on Neuropathic Pain: Randomized N-of-1 Trials
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Funding ran out_difficulties with study product (delays in authorization).
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Yoram Shir
Collaborators
Louise & Alan Edwards Foundation, McGill University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia
Keywords
Soy protein, Milk protein, Neuropathic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Soy Protein
Arm Type
Experimental
Arm Description
30g of soy protein from whole soybean soymilk powder given daily for 3 weeks
Arm Title
Milk Protein
Arm Type
Placebo Comparator
Arm Description
30g of milk protein from whole milk powder given daily for 3 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Whole soybean soymilk powder
Other Intervention Name(s)
Benesoy organic soymilk powder, Code #1386
Intervention Type
Dietary Supplement
Intervention Name(s)
Whole milk powder
Other Intervention Name(s)
Parmalat Code #202006
Primary Outcome Measure Information:
Title
Pain Intensity
Time Frame
Baseline and 3 times during the last week of every treatment period
Secondary Outcome Measure Information:
Title
Pain Quality
Time Frame
Baseline and 3 times during the last week of every treatment period
Title
Dynamic tactile allodynia
Time Frame
Baseline and at the end of every treatment period
Title
Area of dynamic allodynia
Time Frame
Baseline and at the end of every treatment period
Title
Quality of life
Time Frame
Baseline and at the end of every treatment period
Title
Depression
Time Frame
Baseline and at the end of every treatment period
Title
Dietary intake
Time Frame
Baseline, once a week during the first treatment period, once during the second week of the remaining treatment periods.
Title
Body weight
Time Frame
Baseline and at the end of every treatment period
Title
Analgesic medication use
Time Frame
Baseline and 3 times during the last week of every treatment period
Title
Adverse events
Time Frame
The full 18 weeks until the end of the last treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoram Shir, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada

12. IPD Sharing Statement

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The Effect of Soy Protein on Neuropathic Pain

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