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Effect of Buglossoides Oil on Recent Chronic Non-injurious Hip and Knee Pain | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Effect of Buglossoides Oil on Recent Chronic Non-injurious Hip and Knee Pain

NCT03576625•Réseau de Santé Vitalité Health Network

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.

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. 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.
•2. 18 to 65 years of age, inclusive.
•3. Body mass index (BMI) 18 - 39.9 kg/m2
•4. 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.
•5. Subject has no planned knee or hip surgery.
•6. Subject is willing to avoid alcohol consumption for 24h prior to every clinic visit.
•7. The subject will not modify smoking habits during supplementation period.
•8. No significant medical conditions that in the opinion of the qualified physician, would preclude the subject's participation in the study.
•9. Signed informed consent.
•10. 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.
+2 more criteria

Exclusion Criteria

•1. 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.
•2. Has had a diagnosis of rheumatoid arthritis.
•3. 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.
•4. 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.
•5. History or presence of significant, renal, hepatic, gastrointestinal, pulmonary, biliary, neurological or endocrine disorders.
•6. 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).
•7. 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.
•8. Currently being treated for angina, arrhythmia and/or congestive heart failure. History of myocardial infarction or stroke.
•9. Uncontrolled hypertension (resting systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
•10. Type 1 or 2 diabetes. Fasting glucose ≥ 100 mg/dL. HbA1c ≥ 6.0.
+9 more criteria

Locations (1)

Université de Moncton

Moncton, New Brunswick, Canada

Key Dates

Start Date

February 10, 2018

Primary Completion Date

December 1, 2018

Completion Date

December 1, 2018

Last Updated

July 3, 2018

Enrollment

ESTIMATED participants

Conditions

Hip Pain ChronicKnee Pain Chronic

Interventions

High Oleic Sunflower Oil

DIETARY_SUPPLEMENT

Buglossoides Oil

DIETARY_SUPPLEMENT

Contacts

Marc Surette, PhD

CONTACT

1-506-858-4293 marc.surette@umoncton.ca

Patrick-Denis St-Coeur, MSc

CONTACT

1-506-858-4139 patrick-denis.st-coeur@umoncton.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effect of Buglossoides Oil on Recent Chronic Non-injurious Hip and Knee Pain

Inclusion Criteria

Exclusion Criteria

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