NCT04819646

Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation/Discomfort

An Open-label, Single-arm Study to Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation/Discomfort in Individuals Who Are Generally Healthy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Supplement Formulators, Inc. · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess the efficacy and safety of a Marine Lipid Oil Concentrate formulation on inflammation/discomfort and overall well-being in male and female subjects who are generally healthy

Detailed description

This is an open-label, single-arm remote study to evaluate the effects of a Marine Lipid Oil Concentrate formulation on inflammation/discomfort and overall well-being in individuals who are generally healthy. Each subject will receive a specific dose of the study products to be taken once daily for a total of 60 days. Participants complete assessments and questionnaires. The primary objective is the evaluation of the change in the responses to the SF-36 (Short-Form-36) Health Survey, Medical Symptoms questionnaire, Pain questionnaire and responses on an assessment form relative to baseline. Safety and tolerability will be evaluated through receipt of documentation and responses from the telephone contacts/emails as per protocol.

Conditions

• Inflammation

Interventions

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

Timeline

• Start date: 2021-01-07
• Primary completion: 2021-09-03
• Completion: 2021-11-02
• First posted: 2021-03-29
• Last updated: 2023-01-13

Locations

1 site across 1 country: United States