Omega 7 Oil and Inflammatory Biomarker Study
关键词
抽象
描述
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.
日期
最后验证: | 09/30/2019 |
首次提交: | 08/09/2018 |
提交的预估入学人数: | 09/11/2018 |
首次发布: | 09/12/2018 |
上次提交的更新: | 10/13/2019 |
最近更新发布: | 10/14/2019 |
实际学习开始日期: | 08/31/2017 |
预计主要完成日期: | 06/29/2019 |
预计完成日期: | 09/30/2019 |
状况或疾病
干预/治疗
Dietary Supplement: omega 7
Dietary Supplement: Placebo
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: omega 7 - placebo Receiving the active first then switch to the placebo after three weeks | |
Active Comparator: placebo - omega 7 Receiving the placebo first then switch to the active after three weeks |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | 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 |
结果
主要结果指标
1. CRP (serum) [3 weeks]
2. Pain/discomfort (self-assessment from 1 - 10) [3 weeks]
次要成果指标
1. Omega 7 (plasma) [3 weeks]
2. IL-6 (plasma) [3 weeks]
3. TNFalpha (plasma) [3 weeks]