Effects of a Dietary Supplement on Lipoprotein Lipids and Inflammatory Markers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:25 - 69
Updated:5/17/2018
Start Date:March 15, 2017
End Date:January 31, 2018

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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

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.

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.

Inclusion Criteria:

1. Body mass index 18.5-34.9 kg/m2

2. Judged to be in good health on basis of medical history and screening laboratory tests

3. Fasting LDL-C ≥115 mg/dL and <190 mg/dL

Exclusion Criteria:

1. Abnormal laboratory test results of clinical significance (e.g., TG ≥400 mg/dL, blood
glucose ≥126 mg/dL, fasting creatinine ≥1.5 mg/dL, alanine aminotransferase or
aspartate aminotransferase ≥1.5X the upper limit of normal)

2. Atherosclerotic cardiovascular disease or other evidence of atherosclerotic
cardiovascular disease (myocardial infarction or other acute coronary syndrome,
coronary or other revascularization procedure, transient ischemic attack, ischemic
stroke, atherosclerotic peripheral arterial disease or other documented
atherosclerotic diseases)

3. Recent major trauma or surgical event

4. History or presence of clinically important pulmonary, endocrine, hepatic, renal,
hematologic, immunologic, dermatologic, neurologic, psychiatric, or biliary disorders

5. History or current gastrointestinal disorder with the potential to disrupt normal
digestion and absorption

6. Known allergy, sensitivity, or intolerance to any ingredients in the study product

7. Uncontrolled hypertension

8. Recent history of cancer (except non-melanoma skin cancer)

9. Recent weight change ≥4.5 kg

10. History of diagnosed eating disorder

11. Extreme dietary habits

12. Current or recent history of, or strong potential for, drug or alcohol abuse

13. Recent use of medications intended to alter the lipid profile, (e.g., statins, bile
acid sequestrants, cholesterol absorption inhibitor, fibrates, niacin [drug form] or
omega-3 fatty acid drugs), weight-loss drugs or programs, systemic corticosteroids,
anticoagulants, or unstable use of any antihypertensive medication

14. Recent use of foods or dietary supplements with potential to influence lipid
metabolism (e.g., omega-3 fatty acid supplements or fortified foods, sterol/stanol
products, red rice yeast supplements, garlic supplements, soy isoflavone supplements,
niacin or its analogues at doses >400 mg/d) and viscous dietary fiber supplements
(e.g., psyllium, beta-glucan, methylceullylose and/or carrageenan)

15. Recent use of antibiotics

16. Pregnant, planning to be pregnant during the study period or lactating females or
women of childbearing potential unwilling to commit to use of a medically approved
form of contraception
We found this trial at
1
site
Boca Raton, Florida 33434
Phone: 630-222-4593
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Boca Raton, FL
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