The Effect of Soy Protein on Neuropathic Pain

NCT01050244 | Terminated Phase 2

• 1 other identifier: GEN 09-117
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuralgia

Keywords

Soy protein; Milk protein; Neuropathic pain

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  Baseline and 3 times during the last week of every treatment period

Secondary Outcomes (9)

• Pain Quality

  Baseline and 3 times during the last week of every treatment period

• Dynamic tactile allodynia

  Baseline and at the end of every treatment period

• Area of dynamic allodynia

  Baseline and at the end of every treatment period

• Quality of life

  Baseline and at the end of every treatment period

• Depression

  Baseline and at the end of every treatment period

Study Arms (2)

Soy Protein

EXPERIMENTAL

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

Dietary Supplement: Whole soybean soymilk powder

Milk Protein

PLACEBO COMPARATOR

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

Dietary Supplement: Whole milk powder

Interventions

Whole soybean soymilk powder DIETARY_SUPPLEMENT

Also known as: Benesoy organic soymilk powder, Code #1386

Soy Protein

Whole milk powder DIETARY_SUPPLEMENT

Also known as: Parmalat Code #202006

Milk Protein

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Yoram Shir: lead
• Louise & Alan Edwards Foundation: collaborator
• McGill University: collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yoram Shir, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 14, 2010
• First Posted: January 15, 2010
• Study Start: February 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

CA (1)