Omega 7 Oil and Inflammatory Biomarker Study

NCT03669575 | Completed

• 1 other identifier: 16-1575
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Omega 7 (plasma)

  3 weeks

• IL-6 (plasma)

  3 weeks

• TNFalpha (plasma)

  3 weeks

Study Arms (2)

omega 7 - placebo

EXPERIMENTAL

Receiving the active first then switch to the placebo after three weeks

Dietary Supplement: omega 7; Dietary Supplement: Placebo

placebo - omega 7

ACTIVE COMPARATOR

Receiving the placebo first then switch to the active after three weeks

Dietary Supplement: omega 7; Dietary Supplement: Placebo

Interventions

omega 7 DIETARY_SUPPLEMENT

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

omega 7 - placebo; placebo - omega 7

Placebo DIETARY_SUPPLEMENT

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

omega 7 - placebo; placebo - omega 7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bastyr University: lead

Study Sites (1)

Bastyr University Clinical Research Center

Kenmore, Washington, 98028, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

omega-aminoenantic acid

Condition Hierarchy (Ancestors)

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

Study Officials

• Masa Sasagawa, ND, PhD

  Bastyr University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The randomization block of four. Participants, research coordinators, and study clinicians are blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: September 13, 2018
• Study Start: September 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: October 1, 2019
• Last Updated: October 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)