Effects of a Dietary Supplement on Lipoprotein Lipids and Inflammatory Markers
Condition: Healthy Volunteers
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): 300 mg/day of dietary supplement containing carrageenan
Intervention type(s): Dietary Supplement
Intervention description(s): 300 mg/day of dietary supplement containing carrageenan.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care