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Omega 7 Oil and Inflammatory Biomarker Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669575
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Bastyr University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Musculoskeletal Pain Dietary Supplement: omega 7 Dietary Supplement: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Double (Participant, Investigator)
Masking Description: The randomization block of four. Participants, research coordinators, and study clinicians are blinded.
Primary Purpose: Treatment
Official Title: Modulation of Inflammatory Makers by the Supplementation of n7FA for 3 wk, Randomized Placebo Controlled Crossover Study
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : October 1, 2019
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669575


Locations
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United States, Washington
Bastyr University Clinical Research Center
Kenmore, Washington, United States, 98028
Sponsors and Collaborators
Bastyr University
Investigators
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Principal Investigator: Masa Sasagawa, ND, PhD Bastyr University
More Information
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Responsible Party: Bastyr University
ClinicalTrials.gov Identifier: NCT03669575    
Other Study ID Numbers: 16-1575
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations