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Completed

NCT Number: NCT03669575

Omega 7 Oil and Inflammatory Biomarker 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.

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Key information

Conditions

Musculoskeletal Pain Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bastyr University Clinical Research Center

Kenmore, Washington, 98028, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

omega 7

Dietary Supplement

Three weeks omega 7 fatty acid nutritional supplement, approximately 900 mg/day

Placebo

Dietary Supplement

Three weeks placebo fatty acids approximately 900 mg/day which does not contain omega 7

Primary outcomes

  1. CRP (serum)

    Time frame: 3 weeks

    Quantification of the serum hsCRP level during active supplement

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

    Time frame: 3 weeks

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

Secondary outcomes

  1. Omega 7 (plasma)

    Time frame: 3 weeks

    Quantification of the plasma palmitolenic acid (major omega 7 fatty acid) level during the active supplementation

  2. IL-6 (plasma)

    Time frame: 3 weeks

    Quantification of the plasma IL-6 level during the active supplementation

  3. TNFalpha (plasma)

    Time frame: 3 weeks

    Quantification of the plasma TNFalpha level during the active supplementation

Sponsors and collaborators

Lead sponsor

Bastyr University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2018
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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