Effects of a Dietary Supplement on Lipoprotein Lipids and Inflammatory Markers

NCT03118583 | Completed

• 1 other identifier: MB-1608
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• LDL-C

  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)

  Up to 28 days

Secondary Outcomes (6)

• Total-C

  Up to 28 days

• HDL-C

  Upto 28 days

• Total-C/HDL-C

  Up to 28 days

• Non-high-density lipoprotein cholesterol (non-HDL-C)

  Upto 28 days

• Triglycerides (TG)

  Up to 28 days

Study Arms (1)

Dietary supplement with carrageenan

EXPERIMENTAL

300 mg/day of dietary supplement containing carrageenan

Dietary Supplement: 300 mg/day of dietary supplement containing carrageenan

Interventions

300 mg/day of dietary supplement containing carrageenan DIETARY_SUPPLEMENT

300 mg/day of dietary supplement containing carrageenan.

Dietary supplement with carrageenan

Eligibility Criteria

• Age: 25 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index 18.5-34.9 kg/m2
• Judged to be in good health on basis of medical history and screening laboratory tests
• Fasting LDL-C ≥115 mg/dL and \<190 mg/dL

You may not qualify if:

• 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)
• 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)
• Recent major trauma or surgical event
• History or presence of clinically important pulmonary, endocrine, hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric, or biliary disorders
• History or current gastrointestinal disorder with the potential to disrupt normal digestion and absorption
• Known allergy, sensitivity, or intolerance to any ingredients in the study product
• Uncontrolled hypertension
• Recent history of cancer (except non-melanoma skin cancer)
• Recent weight change ≥4.5 kg
• History of diagnosed eating disorder
• Extreme dietary habits
• Current or recent history of, or strong potential for, drug or alcohol abuse
• 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
• 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)
• Recent use of antibiotics

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead

Study Sites (1)

MB Clinical Research

Boca Raton, Florida, 33487, United States

Location

Study Officials

• Kevin C Maki, PhD

  MB Clinical Research and Consulting LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2017
• First Posted: April 18, 2017
• Study Start: March 15, 2017
• Primary Completion: December 31, 2017
• Study Completion: January 31, 2018
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)