Omega 7 Oil and Inflammatory Biomarker Study

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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain
• Intervention / Treatment: Dietary supplement: omega 7; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Kenmore, Washington, United States, 98028
      • Bastyr University Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: omega 7 - placebo; Receiving the active first then switch to the placebo after three weeks	Dietary supplement: omega 7; Three weeks omega 7 fatty acid nutritional supplement, approximately 900 mg/day; Dietary supplement: Placebo; Three weeks placebo fatty acids approximately 900 mg/day which does not contain omega 7
ACTIVE_COMPARATOR: placebo - omega 7; Receiving the placebo first then switch to the active after three weeks	Dietary supplement: omega 7; Three weeks omega 7 fatty acid nutritional supplement, approximately 900 mg/day; Dietary supplement: Placebo; Three weeks placebo fatty acids approximately 900 mg/day which does not contain omega 7

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRP (serum)	Quantification of the serum hsCRP level during active supplement	3 weeks
Pain/discomfort (self-assessment from 1 - 10)	The self-reported level of the musculoskeletal pain/discomfort during active supplement	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Omega 7 (plasma)	Quantification of the plasma palmitolenic acid (major omega 7 fatty acid) level during the active supplementation	3 weeks
IL-6 (plasma)	Quantification of the plasma IL-6 level during the active supplementation	3 weeks
TNFalpha (plasma)	Quantification of the plasma TNFalpha level during the active supplementation	3 weeks

Collaborators and Investigators

• Sponsor: Bastyr University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): October 1, 2019

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (ACTUAL): September 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain
• Other Study ID Numbers: 16-1575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No