Effects of a Dietary Supplement on Lipoprotein Lipids and Inflammatory Markers

Healthy Volunteers Clinical Trial

Official title: An Open-label, Pilot Trial to Assess the Effects of a Dietary Supplement on Fasting Lipoprotein Lipids and a Marker of Inflammation in Men and Women With Above-desirable Levels of Low-density Lipoprotein Cholesterol

Status Completed

Clinical Trial Summary

The goal of this study is to assess the effects of a dietary supplement on fasting lipoprotein lipids and a marker of inflammation in men and women with levels of low-density lipoprotein cholesterol above desirable levels.

Clinical Trial Description

Carrageenan is a naturally occurring plant polysaccharide extracted from edible seaweeds that is widely used in food and beverage products, with a history of use dating back hundreds of years. It is an FDA-approved food additive in the U.S. and has regulatory approval for use as a food ingredient in Europe, Asia, and Latin America.

An earlier clinical trial conducted by the Russian Academy of Sciences demonstrated that consumption of 250 mg/day of carrageenan in capsules, for 28 days, lowered low-density lipoprotein cholesterol (LDL-C) by 34%. In that study, carrageenan consumption also resulted in statistically significant decreases in important biomarkers of chronic inflammation: leukocytes by 16%, fibrinogen by 9%, and C-reactive protein (CRP) by 13%. Another clinical trial conducted by the University of the Philippines showed that carrageenan added to foods led to statistically significant decreases in total cholesterol (total-C) and triglycerides (TG), elevated levels of which are also linked to cardiovascular disease. That study showed that carrageenan consumption led to a 33% reduction in total-C and a 32% reduction in TG.

This is a pilot, open-label, 4 week trial with two screening visits, one baseline visit and two test visits. Subjects will consume 300 mg/day of a proprietary dietary capsule containing carrageenan, with a meal at a consistent time each day, starting at the baseline visit. Fasting blood samples will be collected for lipid profile (total-C, LDL-C, high-density lipoprotein cholesterol [HDL-C], and TG), and high-sensitivity CRP (hs-CRP) measurements at the second screening visit, baseline and the two test visits. Additionally, blood will be drawn for a comprehensive metabolic panel and complete blood count at the second screening and the last test visit only. Assessments of vital signs, body weight, evaluation of inclusion and exclusion criteria, concomitant medication/supplement use, and adverse events will be performed throughout the study. Written study instructions will be provided to the subjects including instructions about fasting, maintenance of adequate hydration, and refraining from vigorous physical activity, alcohol consumption, and tobacco products prior to and during the subsequent visit. At the end of the 4 week test period, subjects will return study product and compliance will be assessed. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT03118583
• Study type: Interventional
• Source: Midwest Center for Metabolic and Cardiovascular Research
• Status: Completed
• Phase: N/A
• Start date: March 15, 2017
• Completion date: January 31, 2018