Omega 7 Oil and Inflammatory Biomarker Study

Bastyr University

Status: Completed

Conditions: Musculoskeletal Pain

Treatments: Dietary Supplement: Placebo; Dietary Supplement: omega 7

Study type: Interventional

Funder types: Other

Identifiers

NCT03669575

16-1575

Details and patient eligibility

About

The purpose of the study is to determine whether the palmitoleic acid supplementation can reduce the serum inflammatory biomarkers and low quality of life scores due to musculoskeletal discomfort. The study design is a 2-arm placebo-controlled double blind crossover trial. The randomized sequence of a single crossover is divided into 1:1 and each supplementation is three weeks with no washout in between.

Full description

The purpose of the study is to investigate whether or not the supplementation of a particular omega-7 fatty acid decreases the serum biomarkers of inflammation, i.e. highly sensitive C-reactive protein, TNF-alpha and IL-6 of participants who have been experiencing decreased quality of life (QOL) and having elevated these serum markers. The study is placebo-controlled and conducted in a double blinded manner. Participants will be crossed over on supplements (active and placebo) in a random sequence. The total length of a trial is six weeks in which the participants will be asked to maintain stable diet. The baseline blood draw, physical exam, range of motion, QOL and dietary assessment and taking vitals are performed. After the blood test results and/or QOL assessment confirm the eligibility, three weeks supply of the investigational supplement will be mailed or picked up in person. The supplementation is one gel-capusule a day for three weeks. At the end of three weeks, another blood draw, physical exam, range of motion, and QOL assessment are conducted; then the other investigational supplement will be provided. The assessment of the second supplement will occur after another three-week mark. If no adverse reaction is observed and there is no concerns, the participant will be exited from the study.

The goal of enrollment is 50 participants who are between 18 to 99 years old with decreased quality of life and potentially elevated serum markers of inflammation. Volunteers will be randomized by a block of four so at any given moment, one group does not exceed more than three participants. The study takes place at Kenmore campus.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: (any of the below)

• baseline CRP 1.0 mg/L or higher
• > 3 months (chronic) musculoskeletal pain/discomfort, which the participant is able to monitor during the course of trial (6 weeks)

Exclusion Criteria:

• Taking narcotic or opioid pain medication
• Unable to monitor NSAID or OTC pain medication quantity
• Unable to visit Kenmore Washington Clinical Research Center for three times
• Objection from his/her primary care doctor
• Employee or family member of Barlines Organics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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56 participants in 2 patient groups

omega 7 - placebo

Experimental group

Description:

Receiving the active first then switch to the placebo after three weeks

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: omega 7

placebo - omega 7

Active Comparator group

Description:

Receiving the placebo first then switch to the active after three weeks

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: omega 7