Effects of Chitin-Glucan on Oxidized Low-Density Lipoprotein (LDL)

Summary

Cardiovascular diseases (CVDs), especially atherosclerotic coronary heart disease and stroke, are the leading causes of death globally. Important risk factors for CVDs include elevated serum levels of total cholesterol, low-density lipoprotein(LDL)-cholesterol, triglycerides, and low high-density lipoprotein (HDL)-cholesterol. Elevated "oxidized" LDL, a pro-inflammatory villain, has also emerged as an important risk factor for the development of CVDs. There is a growing need to identify safe and effective nutritional interventions that offer a clinical benefit aimed at reducing one more of the risk factors for CVDs. Data from many studies in humans have shown various health benefits provided by dietary fiber intake, including an inverse association with the risk of developing cardiovascular disease. The primary purpose of this study is to determine whether daily consumption for 6 weeks of chitin-glucan, a fiber purified from a microorganism, is effective at reducing the amount of oxidized LDL in humans with borderline-to-high LDL-cholesterol. The effects of chitin-glucan on other cardiovascular risk factors will also be evaluated.

Conditions

• Cardiovascular

Interventions

DIETARY_SUPPLEMENT

Chitin-Glucan

3 x 500 mg capsules (tid) = 4.5 mg daily dose

DIETARY_SUPPLEMENT

Low Dose Chitin-Glucan

3 x 167 mg capsules (tid) = 1.5 g daily dose

DIETARY_SUPPLEMENT

Low Dose Chitin-Glucan + Olive Extract

3 x 167 mg capsules (tid) = 1.5 g daily dose (C-G) + 135 mg olive extract

DIETARY_SUPPLEMENT

Placebo

3 x 500 mg capsules (tid)

Sponsors & Collaborators

• Kitozyme

  collaborator INDUSTRY

• Stratum Nutrition

  lead INDUSTRY

Principal Investigators

• Joseph L Evans, PhD · Stratum Nutrition

• James Anderson, MD · Consultant / Advisor (Stratum and KitoZyme)

• Ray Cooper, PhD · Stratum Nutrition

• Veronique Maquet, PhD · Kitozyme

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2011-01-31

Completion

2011-01-31

Countries

• United States
• Canada

Study Locations