Omega 7 Oil and Inflammatory Biomarker Study
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/15/2018 |
| Start Date: | September 1, 2017 |
| End Date: | March 31, 2019 |
| Contact: | Amber Coggins |
| Email: | researchstudy@bastyr.edu |
| Phone: | (425) 896-6834 |
Modulation of Inflammatory Makers by the Supplementation of n7FA for 3 wk, Randomized Placebo Controlled Crossover Study
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.
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.
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.
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.
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
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