Clinical trial NCT03669575: Omega 7 Oil and Inflammatory Biomarker Study
Official title: Modulation of Inflammatory Makers by the Supplementation of n7FA for 3 wk, Randomized Placebo Controlled Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Lead sponsor: Bastyr University
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Eligible participants are randomly assigned to one of two crossover arms, i.e verum-placebo or placebo-verum sequence. The verum groups are dosed approximately 900 mg a day omega-7 fatty acid, and placebo group contains other fatty acids except for omega-7. After the baseline assessment, a participant is on the supplement bottle for three weeks before re-assessed, and starts the second bottle without a washout period. The participant is re-assessed at the end of the six weeks before exits the study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: CRP (serum)
timeFrame: 3 weeks
measure: Pain/discomfort (self-assessment from 1 - 10)
timeFrame: 3 weeks
Secondary outcomes:
measure: Omega 7 (plasma)
timeFrame: 3 weeks
measure: IL-6 (plasma)
timeFrame: 3 weeks
measure: TNFalpha (plasma)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Kenmore
country: United States
facility: Bastyr University Clinical Research Center
state: Washington
Study officials:
affiliation: Bastyr University
name: Masa Sasagawa, ND, PhD
role: PRINCIPAL_INVESTIGATOR
References: