Omega 7 Oil and Inflammatory Biomarker Study

Musculoskeletal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669575
• Other study ID #: 16-1575
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: October 2019
• Source: Bastyr University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 1, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Pain

Intervention

Dietary Supplement:
• omega 7
Three weeks omega 7 fatty acid nutritional supplement, approximately 900 mg/day
• Placebo
Three weeks placebo fatty acids approximately 900 mg/day which does not contain omega 7

Locations

Country	Name	City	State
United States	Bastyr University Clinical Research Center	Kenmore	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bastyr University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRP (serum)	Quantification of the serum hsCRP level during active supplement	3 weeks
Primary	Pain/discomfort (self-assessment from 1 - 10)	The self-reported level of the musculoskeletal pain/discomfort during active supplement	3 weeks
Secondary	Omega 7 (plasma)	Quantification of the plasma palmitolenic acid (major omega 7 fatty acid) level during the active supplementation	3 weeks
Secondary	IL-6 (plasma)	Quantification of the plasma IL-6 level during the active supplementation	3 weeks
Secondary	TNFalpha (plasma)	Quantification of the plasma TNFalpha level during the active supplementation	3 weeks