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Effects of a Dietary Supplement on Lipoprotein Lipids and Inflammatory Markers

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ClinicalTrials.gov Identifier: NCT03118583
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Midwest Center for Metabolic and Cardiovascular Research

Tracking Information
First Submitted Date  ICMJE April 8, 2017
First Posted Date  ICMJE April 18, 2017
Last Update Posted Date May 15, 2018
Actual Study Start Date  ICMJE March 15, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
LDL-C [ Time Frame: Up to 28 days ]
Percent change in LDL-C from baseline (average of values at days -7 and 0) to end of treatment (average of values at days 21 and 28)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
  • Total-C [ Time Frame: Up to 28 days ]
    Percent change in total-C from baseline (average of values at days -7 and 0) to end of treatment (average of values at days 21 and 28)
  • HDL-C [ Time Frame: Upto 28 days ]
    Percent change in HDL-C from baseline (average of values at days -7 and 0) to end of treatment (average of values at days 21 and 28)
  • Total-C/HDL-C [ Time Frame: Up to 28 days ]
    Percent change in the ratio of total-C/HDL-C from baseline (average of values at days -7 and 0) to end of treatment (average of values at days 21 and 28)
  • Non-high-density lipoprotein cholesterol (non-HDL-C) [ Time Frame: Upto 28 days ]
    Percent change in non-HDL-C (calculated as total-C minus HDL-C) from baseline (average of values at days -7 and 0) to end of treatment (average of values at days 21 and 28)
  • Triglycerides (TG) [ Time Frame: Up to 28 days ]
    Percent change in TG from baseline (average of values at days -7 and 0) to end of treatment (average of values at days 21 and 28)
  • hs-CRP [ Time Frame: Up to 28 days ]
    Change in hs-CRP from baseline (average of values at days -7 and 0) to end of treatment (average of values at days 21 and 28)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of a Dietary Supplement on Lipoprotein Lipids and Inflammatory Markers
Official Title  ICMJE 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
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE Dietary Supplement: 300 mg/day of dietary supplement containing carrageenan
300 mg/day of dietary supplement containing carrageenan.
Study Arms  ICMJE Experimental: Dietary supplement with carrageenan
300 mg/day of dietary supplement containing carrageenan
Intervention: Dietary Supplement: 300 mg/day of dietary supplement containing carrageenan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2017)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 31, 2018
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03118583
Other Study ID Numbers  ICMJE MB-1608
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Midwest Center for Metabolic and Cardiovascular Research
Study Sponsor  ICMJE Midwest Center for Metabolic and Cardiovascular Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kevin C Maki, PhD MB Clinical Research and Consulting LLC
PRS Account Midwest Center for Metabolic and Cardiovascular Research
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP