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A Study to Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation

Inflammation Clinical Trial

Official title:
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Specialized Pro-Resolving Mediator Formulation on Inflammation in Individuals Who Are Overweight to Mildly Obese and Otherwise Generally Healthy

Clinical Trial 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.

Clinical Trial Description

This is a double-blind randomized, placebo-controlled study to evaluate the effects of a Marine Lipid Oil Concentrate formulation on inflammation.. Each subject will receive a specific dose of the study product (A) to be taken once daily with a specific dose of the study product (B) to be taken once daily for a total of 60 days. Participants will receive questionnaires, assessments, blood tests, vital signs and a body composition analysis. The primary objective is the assessment of the change in the blood levels of hs-CRP in response to the Marine Lipid Oil Concentrate formulation relative to screening/baseline compared to placebo. The secondary objective is the assessment of the change in the in response to the Marine Lipid Oil Concentrate formulation relative to screening/baseline compared to placebo for Interleukin-6 (IL-6), Tumor necrosis factor (TNF-alpha), Erythrocyte Sedimentation Rate (ESR), Fibrinogen Activity, B-type natriuretic peptide (BNP), Ferritin, Blood lipid levels (Total Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides), Short Form-36 (SF-36) Health Survey scores and the Medical Symptoms Questionnaire ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04269876
Study type Interventional
Source Supplement Formulators, Inc.
Contact
Status Terminated
Phase N/A
Start date October 31, 2019
Completion date September 30, 2021
View Details
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