InflammationPSINCT02998918
Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL
A study testing PolyResveratrol Supplementation and Curcumin Supplementation in people with Inflammation and Atherosclerosis, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Atherosclerosis, Cardiovascular Disease
- What is being tested?
- PolyResveratrol Supplementation and Curcumin Supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- General good health
- Between 18 and 60 years old
- Non-smoker
- Not taking any medications or dietary supplements
Who cannot join
- Taking prescription anti-inflammatory drugs or supplements/drugs that may affect inflammation
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Exercise Research Center
Columbia, South Carolina, 29201
About this study
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.
Read the 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 HDL's 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 (i.e., 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.
- Conditions
- Inflammation, Atherosclerosis, Cardiovascular Disease
- Being tested
- PolyResveratrol Supplementation, Curcumin Supplementation
- Keywords
- Inflammation, HDL, Anti-inflammatory, Supplementation, Curcumin, polyphenol, V-cam, I-cam, atherosclerosis, cardiovascular disease, atherogenesis, antioxidant, resveratrol, quercetin
- Medical subject headings
- Inflammation, Atherosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolyResveratrol SupplementationDietary supplement
Participants will take 1 mg of a polyresveratrol phytosome supplement each day for one week. The acute effect (1 hr) of one 500 mg dose of the polyresveratrol phytosome supplement on inflammation will be examined along with the short-term effect (1 week).
Curcumin SupplementationDietary supplement
Participants will take 1 mg of a curcumin phytosome supplement each day for one week. The acute effect (1 hr) of one 500 mg dose of the curcumin phytosome supplement on inflammation will be examined along with the short-term effect (1 week).
| Study group | Role | What they receive |
|---|---|---|
| PolyResveratrol Supplementation | Experimental | Participants take 500 mg of PolyResveratrol (100 mg curcumin phytosome, 100 mg quercetin phytosome, 100 mg green tea phytosome, 100 mg trans-resveratrol, 100 mg trans-pterostilbene; Thorne Research) twice daily for one week. Two blood Draws are taken on both the first and last days of the week. One blood draw is done fasted just before consumption of one supplement dose, and one blood draw is done after consumption of one supplement dose. Receives: Dietary Supplement: PolyResveratrol Supplementation |
| Curcumin Supplementation | Experimental | Participants take 500 mg of Curcumin phytosome twice daily for one week. Two blood draws are taken on both the first and last days of the week. One blood draw is done fasted just before consumption of one supplement dose, and one blood draw is done after consumption of one supplement dose. Receives: Dietary Supplement: Curcumin Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation Change: HDL Plasma
VCAM-1 expression in HDL plasma will be measured at baseline, and after one week of supplementation for each supplement. Differences in one-week changes in inflammation between each supplement will be compared.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2017
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Sarzynski, University of South Carolina
- Investigators
- Mark Sarzynski, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998918
- Sponsor's protocol ID
- Pro00055882
- Acronym
- PSI
- Status last verified
- Nov 2023
- First submitted
- 18 Oct 2016
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. doi: 10.1056/NEJM199901143400207. No abstract available.
PubMed 9887164Seneviratne AN, Sivagurunathan B, Monaco C. Toll-like receptors and macrophage activation in atherosclerosis. Clin Chim Acta. 2012 Jan 18;413(1-2):3-14. doi: 10.1016/j.cca.2011.08.021. Epub 2011 Aug 22.
PubMed 21884686Emerging Risk Factors Collaboration; Di Angelantonio E, Sarwar N, Perry P, Kaptoge S, Ray KK, Thompson A, Wood AM, Lewington S, Sattar N, Packard CJ, Collins R, Thompson SG, Danesh J. Major lipids, apolipoproteins, and risk of vascular disease. JAMA. 2009 Nov 11;302(18):1993-2000. doi: 10.1001/jama.2009.1619.
PubMed 19903920Toth PP, Barter PJ, Rosenson RS, Boden WE, Chapman MJ, Cuchel M, D'Agostino RB Sr, Davidson MH, Davidson WS, Heinecke JW, Karas RH, Kontush A, Krauss RM, Miller M, Rader DJ. High-density lipoproteins: a consensus statement from the National Lipid Association. J Clin Lipidol. 2013 Sep-Oct;7(5):484-525. doi: 10.1016/j.jacl.2013.08.001. Epub 2013 Aug 11.
PubMed 24079290Barter PJ, Nicholls S, Rye KA, Anantharamaiah GM, Navab M, Fogelman AM. Antiinflammatory properties of HDL. Circ Res. 2004 Oct 15;95(8):764-72. doi: 10.1161/01.RES.0000146094.59640.13.
PubMed 15486323Nicholls SJ, Lundman P, Harmer JA, Cutri B, Griffiths KA, Rye KA, Barter PJ, Celermajer DS. Consumption of saturated fat impairs the anti-inflammatory properties of high-density lipoproteins and endothelial function. J Am Coll Cardiol. 2006 Aug 15;48(4):715-20. doi: 10.1016/j.jacc.2006.04.080. Epub 2006 Jul 24.
PubMed 16904539Bisht K, Wagner KH, Bulmer AC. Curcumin, resveratrol and flavonoids as anti-inflammatory, cyto- and DNA-protective dietary compounds. Toxicology. 2010 Nov 28;278(1):88-100. doi: 10.1016/j.tox.2009.11.008. Epub 2009 Nov 10.
PubMed 19903510Hatcher H, Planalp R, Cho J, Torti FM, Torti SV. Curcumin: from ancient medicine to current clinical trials. Cell Mol Life Sci. 2008 Jun;65(11):1631-52. doi: 10.1007/s00018-008-7452-4.
PubMed 18324353Strimpakos AS, Sharma RA. Curcumin: preventive and therapeutic properties in laboratory studies and clinical trials. Antioxid Redox Signal. 2008 Mar;10(3):511-45. doi: 10.1089/ars.2007.1769.
PubMed 18370854Smoliga JM, Baur JA, Hausenblas HA. Resveratrol and health--a comprehensive review of human clinical trials. Mol Nutr Food Res. 2011 Aug;55(8):1129-41. doi: 10.1002/mnfr.201100143. Epub 2011 Jun 20.
PubMed 21688389Tome-Carneiro J, Larrosa M, Gonzalez-Sarrias A, Tomas-Barberan FA, Garcia-Conesa MT, Espin JC. Resveratrol and clinical trials: the crossroad from in vitro studies to human evidence. Curr Pharm Des. 2013;19(34):6064-93. doi: 10.2174/13816128113199990407.
PubMed 23448440Boots AW, Haenen GR, Bast A. Health effects of quercetin: from antioxidant to nutraceutical. Eur J Pharmacol. 2008 May 13;585(2-3):325-37. doi: 10.1016/j.ejphar.2008.03.008. Epub 2008 Mar 18.
PubMed 18417116Russo M, Spagnuolo C, Tedesco I, Bilotto S, Russo GL. The flavonoid quercetin in disease prevention and therapy: facts and fancies. Biochem Pharmacol. 2012 Jan 1;83(1):6-15. doi: 10.1016/j.bcp.2011.08.010. Epub 2011 Aug 16.
PubMed 21856292Ferrero ME, Bertelli AE, Fulgenzi A, Pellegatta F, Corsi MM, Bonfrate M, Ferrara F, De Caterina R, Giovannini L, Bertelli A. Activity in vitro of resveratrol on granulocyte and monocyte adhesion to endothelium. Am J Clin Nutr. 1998 Dec;68(6):1208-14. doi: 10.1093/ajcn/68.6.1208.
PubMed 9846848Binion DG, Heidemann J, Li MS, Nelson VM, Otterson MF, Rafiee P. Vascular cell adhesion molecule-1 expression in human intestinal microvascular endothelial cells is regulated by PI 3-kinase/Akt/MAPK/NF-kappaB: inhibitory role of curcumin. Am J Physiol Gastrointest Liver Physiol. 2009 Aug;297(2):G259-68. doi: 10.1152/ajpgi.00087.2009. Epub 2009 Jun 11.
PubMed 19520742
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL
- ClinicalTrials.gov ID
- NCT02998918
- Acronym / sponsor ID
- PSI / Pro00055882
- Conditions
- Inflammation, Atherosclerosis, Cardiovascular Disease
- Keywords
- Inflammation, HDL, Anti-inflammatory, Supplementation, Curcumin, polyphenol, V-cam, I-cam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 HDL's 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 (i.e., 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PolyResveratrol Supplementation | Experimental | Dietary Supplement: PolyResveratrol SupplementationParticipants take 500 mg of PolyResveratrol (100 mg curcumin phytosome, 100 mg quercetin phytosome, 100 mg green tea phytosome, 100 mg trans-resveratrol, 100 mg trans-pterostilbene; Thorne Research) twice daily for one week. Two blood Draws are taken on both the first and last days of the week. One blood draw is done fasted just before consumption of one supplement dose, and one blood draw is done after consumption of one supplement dose. |
| Curcumin Supplementation | Experimental | Dietary Supplement: Curcumin SupplementationParticipants take 500 mg of Curcumin phytosome twice daily for one week. Two blood draws are taken on both the first and last days of the week. One blood draw is done fasted just before consumption of one supplement dose, and one blood draw is done after consumption of one supplement dose. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- General good health
- Between 18 and 60 years old
- Non-smoker
- Not taking any medications or dietary supplements
Key exclusion criteria (1 listed)
- Taking prescription anti-inflammatory drugs or supplements/drugs that may affect inflammation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolyResveratrol SupplementationParticipants will take 1 mg of a polyresveratrol phytosome supplement each day for one week. The acute effect (1 hr) of one 500 mg dose of the polyresveratrol phytosome supplement on inflammation will be examined along with the short-term effect (1 week). | Dietary supplement | PolyResveratrol Supplementation |
| Curcumin SupplementationParticipants will take 1 mg of a curcumin phytosome supplement each day for one week. The acute effect (1 hr) of one 500 mg dose of the curcumin phytosome supplement on inflammation will be examined along with the short-term effect (1 week). | Dietary supplement | Curcumin Supplementation |
Primary outcome
Inflammation Change: HDL Plasma
Time frame: One week
VCAM-1 expression in HDL plasma will be measured at baseline, and after one week of supplementation for each supplement. Differences in one-week changes in inflammation between each supplement will be compared.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9887164Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. doi: 10.1056/NEJM199901143400207. No abstract available.
- Background: PubMed 21884686Seneviratne AN, Sivagurunathan B, Monaco C. Toll-like receptors and macrophage activation in atherosclerosis. Clin Chim Acta. 2012 Jan 18;413(1-2):3-14. doi: 10.1016/j.cca.2011.08.021. Epub 2011 Aug 22.
- Background: PubMed 19903920Emerging Risk Factors Collaboration; Di Angelantonio E, Sarwar N, Perry P, Kaptoge S, Ray KK, Thompson A, Wood AM, Lewington S, Sattar N, Packard CJ, Collins R, Thompson SG, Danesh J. Major lipids, apolipoproteins, and risk of vascular disease. JAMA. 2009 Nov 11;302(18):1993-2000. doi: 10.1001/jama.2009.1619.
- Background: PubMed 24079290Toth PP, Barter PJ, Rosenson RS, Boden WE, Chapman MJ, Cuchel M, D'Agostino RB Sr, Davidson MH, Davidson WS, Heinecke JW, Karas RH, Kontush A, Krauss RM, Miller M, Rader DJ. High-density lipoproteins: a consensus statement from the National Lipid Association. J Clin Lipidol. 2013 Sep-Oct;7(5):484-525. doi: 10.1016/j.jacl.2013.08.001. Epub 2013 Aug 11.
- Background: PubMed 15486323Barter PJ, Nicholls S, Rye KA, Anantharamaiah GM, Navab M, Fogelman AM. Antiinflammatory properties of HDL. Circ Res. 2004 Oct 15;95(8):764-72. doi: 10.1161/01.RES.0000146094.59640.13.
- Background: PubMed 16904539Nicholls SJ, Lundman P, Harmer JA, Cutri B, Griffiths KA, Rye KA, Barter PJ, Celermajer DS. Consumption of saturated fat impairs the anti-inflammatory properties of high-density lipoproteins and endothelial function. J Am Coll Cardiol. 2006 Aug 15;48(4):715-20. doi: 10.1016/j.jacc.2006.04.080. Epub 2006 Jul 24.
- Background: PubMed 19903510Bisht K, Wagner KH, Bulmer AC. Curcumin, resveratrol and flavonoids as anti-inflammatory, cyto- and DNA-protective dietary compounds. Toxicology. 2010 Nov 28;278(1):88-100. doi: 10.1016/j.tox.2009.11.008. Epub 2009 Nov 10.
- Background: PubMed 18324353Hatcher H, Planalp R, Cho J, Torti FM, Torti SV. Curcumin: from ancient medicine to current clinical trials. Cell Mol Life Sci. 2008 Jun;65(11):1631-52. doi: 10.1007/s00018-008-7452-4.
- Background: PubMed 18370854Strimpakos AS, Sharma RA. Curcumin: preventive and therapeutic properties in laboratory studies and clinical trials. Antioxid Redox Signal. 2008 Mar;10(3):511-45. doi: 10.1089/ars.2007.1769.
- Background: PubMed 21688389Smoliga JM, Baur JA, Hausenblas HA. Resveratrol and health--a comprehensive review of human clinical trials. Mol Nutr Food Res. 2011 Aug;55(8):1129-41. doi: 10.1002/mnfr.201100143. Epub 2011 Jun 20.
- Background: PubMed 23448440Tome-Carneiro J, Larrosa M, Gonzalez-Sarrias A, Tomas-Barberan FA, Garcia-Conesa MT, Espin JC. Resveratrol and clinical trials: the crossroad from in vitro studies to human evidence. Curr Pharm Des. 2013;19(34):6064-93. doi: 10.2174/13816128113199990407.
- Background: PubMed 18417116Boots AW, Haenen GR, Bast A. Health effects of quercetin: from antioxidant to nutraceutical. Eur J Pharmacol. 2008 May 13;585(2-3):325-37. doi: 10.1016/j.ejphar.2008.03.008. Epub 2008 Mar 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Sarzynski principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PolyResveratrol Supplementation and Curcumin Supplementation in people with Inflammation and Atherosclerosis, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation Change: HDL Plasma (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02998918, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.