NCT04269876

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Supplement Formulators, Inc. · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Inflammation
• Inflammatory Response

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Marine Lipid Oil Concentrate	Marine Lipid Oil Concentrate softgels
DIETARY_SUPPLEMENT	Dietary Supplement	Dietary Supplement capsules
DIETARY_SUPPLEMENT	Placebo	Placebo softgels
DIETARY_SUPPLEMENT	Placebo	Placebo capsules

Timeline

• Start date: 2019-10-31
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2020-02-17
• Last updated: 2023-01-13

Locations

1 site across 1 country: United States