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临床试验/NCT03669575
NCT03669575已完成不适用

Modulation of Inflammatory Makers by the Supplementation of n7FA for 3 wk, Randomized Placebo Controlled Crossover Study

Bastyr University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
CRP (serum)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

The randomization block of four. Participants, research coordinators, and study clinicians are blinded.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •(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)

排除标准

  • •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

研究组 & 干预措施

omega 7 - placebo

Experimental

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

干预措施: omega 7 (Dietary Supplement)

omega 7 - placebo

Experimental

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

干预措施: Placebo (Dietary Supplement)

placebo - omega 7

Active Comparator

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

干预措施: omega 7 (Dietary Supplement)

placebo - omega 7

Active Comparator

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

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

CRP (serum)

时间窗: 3 weeks

Quantification of the serum hsCRP level during active supplement

Pain/discomfort (self-assessment from 1 - 10)

时间窗: 3 weeks

The self-reported level of the musculoskeletal pain/discomfort during active supplement

次要结局

  • Omega 7 (plasma)(3 weeks)
  • IL-6 (plasma)(3 weeks)
  • TNFalpha (plasma)(3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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