Musculoskeletal PainNCT03669575
Omega 7 Oil and Inflammatory Biomarker Study
A study testing omega 7 in people with Musculoskeletal Pain, run by Bastyr University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- omega 7
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Bastyr University Clinical Research Center
Kenmore, Washington, 98028
About this study
Official title: 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.
Read the 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.
- Conditions
- Musculoskeletal Pain
- Being tested
- omega 7, Placebo
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega 7Dietary supplement
Three weeks omega 7 fatty acid nutritional supplement, approximately 900 mg/day
PlaceboDietary supplement
Three weeks placebo fatty acids approximately 900 mg/day which does not contain omega 7
| Study group | Role | What they receive |
|---|---|---|
| omega 7 - placebo | Experimental | Receiving the active first then switch to the placebo after three weeks Receives: Dietary Supplement: omega 7; Dietary Supplement: Placebo |
| placebo - omega 7 | Active comparator | Receiving the placebo first then switch to the active after three weeks Receives: Dietary Supplement: omega 7; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP (serum)
Quantification of the serum hsCRP level during active supplement
Measured: 3 weeks
Pain/discomfort (self-assessment from 1 - 10)
The self-reported level of the musculoskeletal pain/discomfort during active supplement
Measured: 3 weeks
Secondary outcomes (3)
Omega 7 (plasma)
Quantification of the plasma palmitolenic acid (major omega 7 fatty acid) level during the active supplementation
Measured: 3 weeks
IL-6 (plasma)
Quantification of the plasma IL-6 level during the active supplementation
Measured: 3 weeks
TNFalpha (plasma)
Quantification of the plasma TNFalpha level during the active supplementation
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Sep 2017
- Primary completion30 Jun 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bastyr University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Masa Sasagawa, ND, PhD, Principal investigator, Bastyr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669575
- Sponsor's protocol ID
- 16-1575
- Status last verified
- Oct 2019
- First submitted
- 10 Aug 2018
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Inflammatory Makers by the Supplementation of n7FA for 3 wk, Randomized Placebo Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT03669575
- Acronym / sponsor ID
- 16-1575
- Conditions
- Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Bastyr UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| omega 7 - placebo | Experimental | Dietary Supplement: omega 7, Dietary Supplement: PlaceboReceiving the active first then switch to the placebo after three weeks |
| placebo - omega 7 | Active comparator | Dietary Supplement: omega 7, Dietary Supplement: PlaceboReceiving the placebo first then switch to the active after three weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omega 7Three weeks omega 7 fatty acid nutritional supplement, approximately 900 mg/day | Dietary supplement | omega 7 - placebo, placebo - omega 7 |
| PlaceboThree weeks placebo fatty acids approximately 900 mg/day which does not contain omega 7 | Dietary supplement | omega 7 - placebo, placebo - omega 7 |
Primary outcome
CRP (serum)
Time frame: 3 weeks
Quantification of the serum hsCRP level during active supplement
Pain/discomfort (self-assessment from 1 - 10)
Time frame: 3 weeks
The self-reported level of the musculoskeletal pain/discomfort during active supplement
3 secondary outcomes
Omega 7 (plasma)
Time frame: 3 weeks
IL-6 (plasma)
Time frame: 3 weeks
TNFalpha (plasma)
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masa Sasagawa, ND, PhD principal investigator
Bastyr University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega 7 in people with Musculoskeletal Pain, run by Bastyr University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRP (serum) (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.