Status:
COMPLETED
SPM Regulation by Fish Oil Supplements in Healthy Volunteers
Lead Sponsor:
Queen Mary University of London
Collaborating Sponsors:
Metagenics, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
A randomised, double-blind, placebo-controlled study to determine whether fish oil supplementation regulates peripheral levels of specialized pro-resolving mediators and white blood cell responses in ...
Detailed Description
Rationale for the study The relationship between omega-3 essential fatty acid supplementation, and specifically fish oil supplementation, and SPM production in humans is very poorly understood. Given ...
Eligibility Criteria
Inclusion
- For participants to be included in the study they will need to meet the following criteria:
- Able to provide informed consent
- Men and women between the age of 18 and 45
- Declare not to be taking aspirin, other NSAIDS, other form of medication or omega-3 fatty acid supplements for more than 2 weeks prior to screening and the duration of the participation.
- Willingness to abstain from eating fish for 2 days before each study visit
- Willingness to abstain from alcohol consumption for at least 24h prior to each study visit
- Willingness to abstain from caffeine as directed before and during study
Exclusion
- 1\) History of, chronic disorders, cardiovascular disease (e.g., heart disease, stroke), cancer, or diabetes or significant genetically inherited conditions.
- 2\) Pregnancy or breast-feeding. 3) Hypothyroidism in the opinion of the investigator. 4) Liver disease in the opinion of the investigator. 5) Any abnormality or pre-existing disease which, in the opinion of the investigator, might either expose the subject to risk, or influence the validity of the results.
- 6\) Women of childbearing potential not taking adequate methods of contraception 7) Inability to read and write in English 8) Participation in a clinical study of a new chemical entity, biological product or a prescription medicine, or loss of more than 400 mL blood, within the previous 3 months 9) Anyone who is currently smoking or used to smoke 10) Presence or history of drug or alcohol abuse or intake of more than the amount of alcohol in the current guidelines on alcohol consumption
Key Trial Info
Start Date :
March 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03347006
Start Date
March 20 2017
End Date
June 15 2018
Last Update
May 25 2025
Active Locations (1)
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1
Queen Mary University of London
London, United Kingdom, EC1M 6BQ