Hip Pain ChronicPhase 1NCT03576625
Effect of Buglossoides Oil on Recent Chronic Non-injurious Hip and Knee Pain
A Phase 1 study testing High Oleic Sunflower Oil and Buglossoides Oil in people with Hip Pain Chronic and Knee Pain Chronic, run by Réseau de Santé Vitalité Health Network at 1 site in Canada.
Trial summary
The effect of Buglossoides oil emulsion on the intensity of recent chronic knee and hip pain, on plasma and mononuclear blood cells fatty acid profiles and on whole blood Eicosapentaenoic acid production will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Pain Chronic, Knee Pain Chronic
- What is being tested?
- High Oleic Sunflower Oil and Buglossoides Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 10 Feb 2018to Dec 2018
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or non-pregnant women, using an effective form of birth control (such as oral contraceptives, injectable contraceptives or the barrier method such as a intrauterine device (IUD) with a spermicide, a diaphragm with a spermicide, a condom with a spermicide or a sponge with a spermicide) for at least 3 months prior to entry into the study and continuing during participation in the study.
- 18 to 65 years of age, inclusive.
- Body mass index (BMI) 18 - 39.9 kg/m2
- Subject has recent (less than 6 months) current chronic (having lasted more than two weeks) knee (one or both) and/or hip pain that is not the result of an acute injury. Pain intensity is 20 mm or higher using a Visual Analog Scale ranging from 0-100 mm.
- Subject has no planned knee or hip surgery.
- Subject is willing to avoid alcohol consumption for 24h prior to every clinic visit.
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- The subject will not modify smoking habits during supplementation period.
- No significant medical conditions that in the opinion of the qualified physician, would preclude the subject's participation in the study.
- Signed informed consent.
- Willing to follow all study procedures including study visits, fasting blood draws, stable body weight, normal eating habits, current activity level, and compliance with study preparation.
- Willing to not consume fish, crustaceans and shellfish for the duration of the study.
- Willing to avoid taking anti-inflammatory medications (analgesics and NSAIDs) for 24 hours prior to Visits 2 and 5.
Who cannot join
- Pregnancy or lactation. Women trying to conceive. Women who will try to conceive who are unwilling to commit to the use of a medically approved form of contraception throughout the study period. Method of contraception must be recorded in the case report file.
- Has had a diagnosis of rheumatoid arthritis.
- Individual has a condition the study physician believes would interfere with the participant's ability to provide informed consent, comply with his responsibilities during the study, which might confound the interpretation of the study results or put the person at undue risk.
- Self-reported medical conditions including an active peptic ulcer, inflammatory bowel disease, or gastrointestinal bleeding and any medical condition or prior gastrointestinal surgery that could influence absorption, metabolism or excretion of the study supplement.
- History or presence of significant, renal, hepatic, gastrointestinal, pulmonary, biliary, neurological or endocrine disorders.
- History or presence of cancer in the past 2 yrs, except for non-melanoma skin cancers (e.g. basal or squamous cell carcinoma of the skin).
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- Clinically significant abnormal laboratory test results including but not limited to LDL-cholesterol ≥ 4.1mM, triglyceride levels ≥3.95mM, fasting creatinine ≥ 1.5 mg/dL, ALT or AST ≥ 1.5X the upper limit of normal.
- Currently being treated for angina, arrhythmia and/or congestive heart failure. History of myocardial infarction or stroke.
- Uncontrolled hypertension (resting systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
- Type 1 or 2 diabetes. Fasting glucose ≥ 100 mg/dL. HbA1c ≥ 6.0.
- If a smoker, subject smokes no more than 1 pack (20 cigarettes) daily.
- History (within 12 months) or current alcohol or substance abuse (no more than 14 consumptions per week; 1 consumption= 12 oz beer, 5 oz wine, 1.5 oz distilled spirits).
- Use of steroidal anti-inflammatory medications (prednisone, etc)
- Use of any lipid-altering medications (statins, bile acid sequestrants, cholesterol absorption inhibitors, fibrates, prescription formulations of niacin).
- Unstable use of thyroid medication. Stable, treated hypothyroidism is not an exclusion criteria.
- Use of any weight loss or lipid metabolism medication/supplement/program (including lipase inhibitors) within 1 month of study period OR weight gain or loss > 2 kg in the past 3 months.
- Currently taking fish oil or any other omega-3 or omega-6 PUFA supplement/drug within one month of Visit 1 and throughout the study. Consumption of fatty fish (salmon, herring, mackerel, albacore tuna, and sardines) more than 2X a month within one month of visit 1 and throughout the study period. Consumption (more than twice a month) of any EPA/DHA enriched foods (e.g. DHA-enriched eggs) within one month of Visit 1. Unwillingness to avoid all fish including shellfish and crustaceans throughout the study period.
- Use of alpha-linolenic acid-containing seeds and oils such as flax seed, chia seed, perilla seed, hemp, spirulina, walnut, mustard seed or black currant seeds/oil within one month of Visit 1 and throughout the study.
- Use of an investigational product within the previous 30 days.
- Has donated blood up to 4 weeks before the start of the study. Not willing to cease being a blood donor during the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Université de Moncton
Moncton, New Brunswick, E1A3E9
Patrick-Denis St-Coeur, MSc, 1-506-858-4139, patrick-denis.st-coeur@umoncton.ca
About this study
The effect of Buglossoides oil emulsion on the intensity of recent chronic knee and hip pain, on plasma and mononuclear blood cells fatty acid profiles and on whole blood Eicosapentaenoic acid production will be investigated.
Read the detailed description
This study will document the impact of an emulsion of Buglossoides oil on the intensity of recent chronic knee and hip pain. Secondly, the impact of consuming Buglossoides oil on plasma and leukocyte fatty acid profiles will be investigated, thus providing clinical evidence on the efficacy of an emulsion of Buglossoides oil in increasing EPA content. Lastly, a comprehensive analysis of whole blood eicosanoid production following supplementation will provide data on the potential for Buglossoides oil to modulate immune function.
- Conditions
- Hip Pain Chronic, Knee Pain Chronic
- Being tested
- High Oleic Sunflower Oil, Buglossoides Oil
- Keywords
- Buglossoides arvensis, vegetable oil, omega-3 fatty acids, participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Oleic Sunflower OilDietary supplement
Also called HOSO
Consume oil smoothie (emulsified HOSO) with a meal once daily for 9 weeks
Buglossoides OilDietary supplement
Also called Ahiflower
Consume oil smoothie (emulsified Buglossoides oil) with a meal once daily for 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| High oleic sunflower oil (HOSO) | Placebo comparator | 30 ml HOSO emulsion (equivalent to 9.9 ml oil) in a single dose, 56 days Receives: Dietary Supplement: High Oleic Sunflower Oil |
| Buglossoides oil emulsion | Experimental | 30 ml Buglossoides oil emulsion (equivalent to 9.9 ml oil) in a single dose, 56 days Receives: Dietary Supplement: Buglossoides Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the nature of pain severity
Defined by visual analogue scale (VAS)
Measured: Baseline, 19, 38, 56 days
Change in the nature of fatigue severity
Defined by visual analogue scale (VAS)
Measured: Baseline, 19, 38, 56 days
Secondary outcomes (8)
Nature and frequency of analgesic use
Measured: 56 days
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness and physical function scores
Measured: Baseline, 19, 38, 56 days
Plasma eicosapentaenoic concentration (EPA)
Expressed as umol/L plasma
Measured: Baseline and day 56
Plasma 20:4n-3
Expressed as umol/L plasma
Measured: Baseline and day 56
Plasma docosapentaenoic acid
Expressed as umol/L plasma
Measured: Baseline and day 56
Plasma 20:4n-3, EPA and DPA individually as % of total fatty acids
Measured: Baseline and day 56
Mononuclear cell 20:4n-3, EPA and DPA individually as % of total fatty acids
Measured: Baseline and day 56
Eicosanoid profile following ex vivo whole blood immune challenge
Measured: Baseline and day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start10 Feb 2018
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Pain ChronicStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Réseau de Santé Vitalité Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Surette, PhD, Principal investigator, Université de Moncton, Moncton, NB, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576625
- Sponsor's protocol ID
- HC-NNHPD-230190
- Status last verified
- Sep 2017
- First submitted
- 11 Jun 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Buglossoides Oil on Recent Chronic Non-injurious Hip and Knee Pain
- ClinicalTrials.gov ID
- NCT03576625
- Acronym / sponsor ID
- HC-NNHPD-230190
- Conditions
- Hip Pain Chronic, Knee Pain Chronic
- Keywords
- Buglossoides arvensis, vegetable oil, omega-3 fatty acids, participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Réseau de Santé Vitalité Health NetworkUniversity, hospital or other
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 3 Jul 2018 (actual)
- 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.
The effect of Buglossoides oil emulsion on the intensity of recent chronic knee and hip pain, on plasma and mononuclear blood cells fatty acid profiles and on whole blood Eicosapentaenoic acid production will be investigated.
Detailed description
This study will document the impact of an emulsion of Buglossoides oil on the intensity of recent chronic knee and hip pain. Secondly, the impact of consuming Buglossoides oil on plasma and leukocyte fatty acid profiles will be investigated, thus providing clinical evidence on the efficacy of an emulsion of Buglossoides oil in increasing EPA content. Lastly, a comprehensive analysis of whole blood eicosanoid production following supplementation will provide data on the potential for Buglossoides oil to modulate immune function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High oleic sunflower oil (HOSO) | Placebo comparator | Dietary Supplement: High Oleic Sunflower Oil30 ml HOSO emulsion (equivalent to 9.9 ml oil) in a single dose, 56 days |
| Buglossoides oil emulsion | Experimental | Dietary Supplement: Buglossoides Oil30 ml Buglossoides oil emulsion (equivalent to 9.9 ml oil) in a single dose, 56 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men or non-pregnant women, using an effective form of birth control (such as oral contraceptives, injectable contraceptives or the barrier method such as a intrauterine device (IUD) with a spermicide, a diaphragm with a spermicide, a condom with a spermicide or a sponge with a spermicide) for at least 3 months prior to entry into the study and continuing during participation in the study.
- 18 to 65 years of age, inclusive.
- Body mass index (BMI) 18 - 39.9 kg/m2
- Subject has recent (less than 6 months) current chronic (having lasted more than two weeks) knee (one or both) and/or hip pain that is not the result of an acute injury. Pain intensity is 20 mm or higher using a Visual Analog Scale ranging from 0-100 mm.
- Subject has no planned knee or hip surgery.
Key exclusion criteria (20 listed)
- Pregnancy or lactation. Women trying to conceive. Women who will try to conceive who are unwilling to commit to the use of a medically approved form of contraception throughout the study period. Method of contraception must be recorded in the case report file.
- Has had a diagnosis of rheumatoid arthritis.
- Individual has a condition the study physician believes would interfere with the participant's ability to provide informed consent, comply with his responsibilities during the study, which might confound the interpretation of the study results or put the person at undue risk.
- Self-reported medical conditions including an active peptic ulcer, inflammatory bowel disease, or gastrointestinal bleeding and any medical condition or prior gastrointestinal surgery that could influence absorption, metabolism or excretion of the study supplement.
- History or presence of significant, renal, hepatic, gastrointestinal, pulmonary, biliary, neurological or endocrine disorders.
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 |
|---|---|---|
| High Oleic Sunflower OilAlso: HOSOConsume oil smoothie (emulsified HOSO) with a meal once daily for 9 weeks | Dietary supplement | High oleic sunflower oil (HOSO) |
| Buglossoides OilAlso: AhiflowerConsume oil smoothie (emulsified Buglossoides oil) with a meal once daily for 9 weeks | Dietary supplement | Buglossoides oil emulsion |
Primary outcome
Change in the nature of pain severity
Time frame: Baseline, 19, 38, 56 days
Defined by visual analogue scale (VAS)
Change in the nature of fatigue severity
Time frame: Baseline, 19, 38, 56 days
Defined by visual analogue scale (VAS)
8 secondary outcomes
Nature and frequency of analgesic use
Time frame: 56 days
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness and physical function scores
Time frame: Baseline, 19, 38, 56 days
Plasma eicosapentaenoic concentration (EPA)
Time frame: Baseline and day 56
Plasma 20:4n-3
Time frame: Baseline and day 56
Plasma docosapentaenoic acid
Time frame: Baseline and day 56
Plasma 20:4n-3, EPA and DPA individually as % of total fatty acids
Time frame: Baseline and day 56
Mononuclear cell 20:4n-3, EPA and DPA individually as % of total fatty acids
Time frame: Baseline and day 56
Eicosanoid profile following ex vivo whole blood immune challenge
Time frame: Baseline and day 56
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
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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.
Marc Surette, PhD principal investigator
Université de Moncton, Moncton, NB, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing High Oleic Sunflower Oil and Buglossoides Oil in people with Hip Pain Chronic and Knee Pain Chronic, run by Réseau de Santé Vitalité Health Network 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 12 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 3 Jul 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Surette, PhD (1-506-858-4293, marc.surette@umoncton.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the nature of pain severity (time frame: Baseline, 19, 38, 56 days). The study lists 2 primary outcomes in all. 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 3 Jul 2018.