Ignite Creation Date:
2024-05-06 @ 9:29 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02998918
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2016-10-18
Brief Title:
Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL
Sponsor:
University of South Carolina
Organization:
University of South Carolina
Study Overview
Official Title:
Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL
Status:
COMPLETED
Status Verified Date:
2023-11
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:
PSI
Brief Summary:
Polyphenol supplements including curcumin and resveratrol are known to decrease inflammation but previous polyphenol supplements were poorly absorbed and thus their effects were reduced A new phytosome formulation coats the supplements and allows them to be better absorbed The purpose of this study is to examine the acute 1-hr and short-term 1-week effects of two different phytosome-formulated polyphenol supplements on inflammation The two supplements that will be used are 1 PolyResveratrol and 2 Curcumin
Detailed Description:
Atherosclerosis is a chronic inflammatory disease underlying coronary artery disease driven in part by the innate immune system particularly macrophages The adhesion of leukocytes to the vascular endothelium mediated by endothelial cellular adhesion molecules including vascular adhesion molecule-1 VCAM-1 and intercellular adhesion molecule-1 ICAM-1 is one of the crucial initial steps in atherogenesis Elevated levels of high-density lipoprotein cholesterol HDL-C are associated with reduced risk for cardiovascular disease CVD however interventions designed to increase HDL-C concentration in humans have yet to lead to reductions in cardiovascular events A possible explanation for the failure of recent clinical trials is the structural and functional complexity of HDL particles which have multiple cardioprotective properties including anti-inflammatory antioxidative and reverse cholesterol transport activities The anti-inflammatory effects of HDL include reduction of inflammatory cytokines and vascular leukocyte adhesion molecules A recent study showed that dietary composition can affect HDLs anti-inflammatory properties namely the ability to inhibit the expression of ICAM-1 and VCAM-1
Numerous studies have shown that polyphenols including curcumin quercetin and resveratrol exhibit multiple health benefits including anti-inflammatory properties Curcumin is a flavonoid polyphenol that is the active ingredient in the spice turmeric Quercetin is one of the most abundant dietary flavonoids and is found in many fruits vegetables and beverages Resveratrol is a non-flavonoid polyphenol present in a limited number of plant-derived foods including grapes and peanuts In vitro studies show these three polyphenols independently decrease VCAM-1 and ICAM-1 expression induced by tumor necrosis factor alpha TNFα in human endothelial cells as well as increase cholesterol efflux to apolipoprotein A-I apoA-I and HDL in macrophages However previous in vitro models used direct incubation with each polyphenol ie HDL was directly exposed to the polyphenol in the cell culture as opposed to incubation with plasma after consumption of the polyphenol with doses much higher than found in typical human diets or supplements
The health effects of polyphenols in humans are limited by their poor bioavailability as they are rapidly metabolized and excreted Recent studies have found that formulating poorly-absorbed molecules with phosphatidylcholine via phytosomes increases their bioavailability For example recent studies comparing curcumin phytosome Meriva and standard curcumin formulations in humans found that the curcumin phytosome formulation increased curcuminoid bioavailability between 8- to 29-fold To our knowledge no study has examined the effects of polyphenol supplementation particularly phytosome-formulated polyphenols in humans on the ability of circulating plasma to inhibit the expression of cellular adhesion molecules or enhance cholesterol efflux capacity in vitro Furthermore it is unknown whether polyphenol supplementation modulates the ability of HDL particles to perform these same functions
Therefore the purpose of this study is to examine whether acute and short-term 1-week polyphenol supplementation in humans affects inflammation measured at the whole plasma level as well as the inflammatory and cholesterol efflux properties of HDL particles The investigators will test the effects of two supplements in a cross-over design a curcumin phytosome and a multi-polyphenol supplement containing curcumin phytosome quercetin phytosome and trans-resveratrol The investigators hypothesize that one of the mechanisms by which polyphenols exert a beneficial effect on inflammation and atherosclerosis is through its modulation of HDL particles
Numerous studies have shown that polyphenols including curcumin quercetin and resveratrol exhibit multiple health benefits including anti-inflammatory properties Curcumin is a flavonoid polyphenol that is the active ingredient in the spice turmeric Quercetin is one of the most abundant dietary flavonoids and is found in many fruits vegetables and beverages Resveratrol is a non-flavonoid polyphenol present in a limited number of plant-derived foods including grapes and peanuts In vitro studies show these three polyphenols independently decrease VCAM-1 and ICAM-1 expression induced by tumor necrosis factor alpha TNFα in human endothelial cells as well as increase cholesterol efflux to apolipoprotein A-I apoA-I and HDL in macrophages However previous in vitro models used direct incubation with each polyphenol ie HDL was directly exposed to the polyphenol in the cell culture as opposed to incubation with plasma after consumption of the polyphenol with doses much higher than found in typical human diets or supplements
The health effects of polyphenols in humans are limited by their poor bioavailability as they are rapidly metabolized and excreted Recent studies have found that formulating poorly-absorbed molecules with phosphatidylcholine via phytosomes increases their bioavailability For example recent studies comparing curcumin phytosome Meriva and standard curcumin formulations in humans found that the curcumin phytosome formulation increased curcuminoid bioavailability between 8- to 29-fold To our knowledge no study has examined the effects of polyphenol supplementation particularly phytosome-formulated polyphenols in humans on the ability of circulating plasma to inhibit the expression of cellular adhesion molecules or enhance cholesterol efflux capacity in vitro Furthermore it is unknown whether polyphenol supplementation modulates the ability of HDL particles to perform these same functions
Therefore the purpose of this study is to examine whether acute and short-term 1-week polyphenol supplementation in humans affects inflammation measured at the whole plasma level as well as the inflammatory and cholesterol efflux properties of HDL particles The investigators will test the effects of two supplements in a cross-over design a curcumin phytosome and a multi-polyphenol supplement containing curcumin phytosome quercetin phytosome and trans-resveratrol The investigators hypothesize that one of the mechanisms by which polyphenols exert a beneficial effect on inflammation and atherosclerosis is through its modulation of HDL particles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None