A Study to Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation (NCT04269876) | Clinical Trial Compass
TerminatedNot Applicable
A Study to Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation
Stopped: COVID-19 pandemic
United States8 participantsStarted 2019-10-31
Plain-language summary
To assess the efficacy and safety of a Marine Lipid Oil Concentrate formulation on inflammatory biomarkers and overall well-being in male and female subjects who are overweight to mildly obese, but otherwise generally healthy.
Who can participate
Age range35 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Ambulatory, male or female, 35-75 years of age
✓. A BMI of 23-34.9
✓. hs-CRP level of 1-7.5 mg/L
✓. Generally healthy and having no significant difficulty with digestion or absorption of food
✓. Has been generally weight stable for the past six months (+/- 6 lbs.)
✓. Willing and able to give written informed consent
✓. Clearly understands the procedures and study requirements
✓. Willing and able to comply with all study procedures, including following the recommendations to maintain their usual diet and regular activity, as per protocol
Exclusion criteria
✕. Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug as well as any product containing cannabidiol (CBD) and tetrahydrocannabinol in the past 30 days.
✕. Donated blood within 30 days before Screening/baseline
✕. Inability to provide a venous blood sample
✕. Participation in another study within 30 days before Screening/baseline
✕. Being pregnant or planning on becoming pregnant during study participation; or breast feeding
What they're measuring
1
Assessment of the mean or median change in high sensitivity C-reactive protein (hs-CRP) relative to baseline
✕. History of allergy or sensitivity to any component of the study products
✕. Currently taking a lipid lowering medication or dietary supplement
✕. Currently taking a medication or dietary supplement specifically for pain or inflammation including curcumin and unwilling to washout (i.e., stop taking) for 14 days before Screening/baseline