CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 135 enrolled
Drug / intervention
Chitin-Glucan +3 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01232309
NCT01232309N/ACompleted

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Effects of Chitin-Glucan on Oxidized Low-Density Lipoprotein (LDL)

Stratum Nutrition·interventional·Posted Nov 2, 2010·Updated Oct 23, 2012

In Brief

A clinical study evaluating Chitin-Glucan, Low Dose Chitin-Glucan, and 2 other interventions for Cardiovascular. Completed, enrolled 135 participants across 3 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular
CountriesCanada, United States
CollaboratorsKitozyme

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2, 2010
Enrollment StartAug 1, 2010
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.7 years ago

Interventions

Chitin-Glucandietary

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

Low Dose Chitin-Glucandietary

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

Low Dose Chitin-Glucan + Olive Extractdietary

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

Placebodietary

3 x 500 mg capsules (tid)