Ignite Creation Date:
2024-05-06 @ 9:56 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03118583
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
2017-04-08
Brief Title:
Effects of a Dietary Supplement on Lipoprotein Lipids and Inflammatory Markers
Sponsor:
Midwest Center for Metabolic and Cardiovascular Research
Organization:
Midwest Center for Metabolic and Cardiovascular Research
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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 mgday 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 mgday 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 medicationsupplement 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
An earlier clinical trial conducted by the Russian Academy of Sciences demonstrated that consumption of 250 mgday 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 mgday 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 medicationsupplement 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None