NeuralgiaPhase 2NCT01050244
The Effect of Soy Protein on Neuropathic Pain
A Phase 2 study testing Whole soybean soymilk powder and Whole milk powder in people with Neuralgia, run by Dr. Yoram Shir at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuralgia
- What is being tested?
- Whole soybean soymilk powder and Whole milk powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to Nov 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Soy Protein on Neuropathic Pain: Randomized N-of-1 Trials
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.
Read the 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
- Being tested
- Whole soybean soymilk powder, Whole milk powder
- Keywords
- Soy protein, Milk protein, Neuropathic pain
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole soybean soymilk powderDietary supplement
Also called Benesoy organic soymilk powder, Code #1386
Whole milk powderDietary supplement
Also called Parmalat Code #202006
| Study group | Role | What they receive |
|---|---|---|
| Soy Protein | Experimental | 30g of soy protein from whole soybean soymilk powder given daily for 3 weeks Receives: Dietary Supplement: Whole soybean soymilk powder |
| Milk Protein | Placebo comparator | 30g of milk protein from whole milk powder given daily for 3 weeks Receives: Dietary Supplement: Whole milk powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Measured: Baseline and 3 times during the last week of every treatment period
Secondary outcomes (9)
Pain Quality
Measured: Baseline and 3 times during the last week of every treatment period
Dynamic tactile allodynia
Measured: Baseline and at the end of every treatment period
Area of dynamic allodynia
Measured: Baseline and at the end of every treatment period
Quality of life
Measured: Baseline and at the end of every treatment period
Depression
Measured: Baseline and at the end of every treatment period
Dietary intake
Measured: Baseline, once a week during the first treatment period, once during the second week of the remaining treatment periods.
Body weight
Measured: Baseline and at the end of every treatment period
Analgesic medication use
Measured: Baseline and 3 times during the last week of every treatment period
Adverse events
Measured: The full 18 weeks until the end of the last treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startFeb 2011
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Funding ran out\_difficulties with study product (delays in authorization).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Yoram Shir
- Sponsor type
- University, hospital or other
- Collaborators
- Louise & Alan Edwards Foundation, McGill University
- Responsible party
- Sponsor-investigator, Dr. Yoram Shir, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Yoram Shir, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050244
- Sponsor's protocol ID
- GEN 09-117
- Status last verified
- Mar 2016
- First submitted
- 14 Jan 2010
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Soy Protein on Neuropathic Pain: Randomized N-of-1 Trials
- ClinicalTrials.gov ID
- NCT01050244
- Acronym / sponsor ID
- GEN 09-117
- Conditions
- Neuralgia
- Keywords
- Soy protein, Milk protein, Neuropathic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ran out\_difficulties with study product (delays in authorization).
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Dr. Yoram ShirUniversity, hospital or other
- Collaborators
- Louise & Alan Edwards Foundation, McGill University
- Study start
- Feb 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soy Protein | Experimental | Dietary Supplement: Whole soybean soymilk powder30g of soy protein from whole soybean soymilk powder given daily for 3 weeks |
| Milk Protein | Placebo comparator | Dietary Supplement: Whole milk powder30g of milk protein from whole milk powder given daily for 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole soybean soymilk powderAlso: Benesoy organic soymilk powder, Code #1386 | Dietary supplement | Soy Protein |
| Whole milk powderAlso: Parmalat Code #202006 | Dietary supplement | Milk Protein |
Primary outcome
Pain Intensity
Time frame: Baseline and 3 times during the last week of every treatment period
9 secondary outcomes
Pain Quality
Time frame: Baseline and 3 times during the last week of every treatment period
Dynamic tactile allodynia
Time frame: Baseline and at the end of every treatment period
Area of dynamic allodynia
Time frame: Baseline and at the end of every treatment period
Quality of life
Time frame: Baseline and at the end of every treatment period
Depression
Time frame: Baseline and at the end of every treatment period
Dietary intake
Time frame: Baseline, once a week during the first treatment period, once during the second week of the remaining treatment periods.
Body weight
Time frame: Baseline and at the end of every treatment period
Analgesic medication use
Time frame: Baseline and 3 times during the last week of every treatment period
Adverse events
Time frame: The full 18 weeks until the end of the last treatment period
Results and safety
The study was stopped early (reason given: Funding ran out\_difficulties with study product (delays in authorization).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoram Shir, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Whole soybean soymilk powder and Whole milk powder in people with Neuralgia, run by Dr. Yoram Shir at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding ran out\_difficulties with study product (delays in authorization).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Baseline and 3 times during the last week of every treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.