<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02998918</url>
  </required_header>
  <id_info>
    <org_study_id>COBRE PSI</org_study_id>
    <nct_id>NCT02998918</nct_id>
  </id_info>
  <brief_title>Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL</brief_title>
  <acronym>PSI</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of South Carolina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Polyphenol supplements, including curcumin and resveratrol, are known to decrease&#xD;
      inflammation, but previous polyphenol supplements were poorly absorbed and thus their effects&#xD;
      were reduced. A new phytosome formulation coats the supplements and allows them to be better&#xD;
      absorbed. The purpose of this study is to examine the acute (1-hr) and short-term (1-week)&#xD;
      effects of two different phytosome-formulated polyphenol supplements on inflammation. The two&#xD;
      supplements that will be used are: 1) PolyResveratrol and 2) Curcumin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atherosclerosis is a chronic inflammatory disease underlying coronary artery disease, driven&#xD;
      in part by the innate immune system, particularly macrophages. The adhesion of leukocytes to&#xD;
      the vascular endothelium, mediated by endothelial cellular adhesion molecules including&#xD;
      vascular adhesion molecule-1 (VCAM-1) and intercellular adhesion molecule-1 (ICAM-1), is one&#xD;
      of the crucial initial steps in atherogenesis. Elevated levels of high-density lipoprotein&#xD;
      cholesterol (HDL-C) are associated with reduced risk for cardiovascular disease (CVD);&#xD;
      however, interventions designed to increase HDL-C concentration in humans have yet to lead to&#xD;
      reductions in cardiovascular events. A possible explanation for the failure of recent&#xD;
      clinical trials is the structural and functional complexity of HDL particles, which have&#xD;
      multiple cardioprotective properties, including anti-inflammatory, antioxidative, and reverse&#xD;
      cholesterol transport activities. The anti-inflammatory effects of HDL include reduction of&#xD;
      inflammatory cytokines and vascular leukocyte adhesion molecules. A recent study showed that&#xD;
      dietary composition can affect HDL's anti-inflammatory properties, namely the ability to&#xD;
      inhibit the expression of ICAM-1 and VCAM-1.&#xD;
&#xD;
      Numerous studies have shown that polyphenols, including curcumin, quercetin, and resveratrol,&#xD;
      exhibit multiple health benefits, including anti-inflammatory properties. Curcumin is a&#xD;
      flavonoid polyphenol that is the active ingredient in the spice turmeric. Quercetin is one of&#xD;
      the most abundant dietary flavonoids and is found in many fruits, vegetables, and beverages.&#xD;
      Resveratrol is a non-flavonoid polyphenol present in a limited number of plant-derived foods,&#xD;
      including grapes and peanuts. In vitro studies show these three polyphenols independently&#xD;
      decrease VCAM-1 and ICAM-1 expression induced by tumor necrosis factor alpha (TNFα) in human&#xD;
      endothelial cells, as well as increase cholesterol efflux to apolipoprotein A-I (apoA-I) and&#xD;
      HDL in macrophages. However, previous in vitro models used direct incubation with each&#xD;
      polyphenol (i.e., HDL was directly exposed to the polyphenol in the cell culture, as opposed&#xD;
      to incubation with plasma after consumption of the polyphenol), with doses much higher than&#xD;
      found in typical human diets or supplements.&#xD;
&#xD;
      The health effects of polyphenols in humans are limited by their poor bioavailability, as&#xD;
      they are rapidly metabolized and excreted. Recent studies have found that formulating&#xD;
      poorly-absorbed molecules with phosphatidylcholine via phytosomes increases their&#xD;
      bioavailability. For example, recent studies comparing curcumin phytosome (Meriva®) and&#xD;
      standard curcumin formulations in humans found that the curcumin phytosome formulation&#xD;
      increased curcuminoid bioavailability between 8- to 29-fold. To our knowledge, no study has&#xD;
      examined the effects of polyphenol supplementation, particularly phytosome-formulated&#xD;
      polyphenols, in humans on the ability of circulating plasma to inhibit the expression of&#xD;
      cellular adhesion molecules or enhance cholesterol efflux capacity in vitro. Furthermore, it&#xD;
      is unknown whether polyphenol supplementation modulates the ability of HDL particles to&#xD;
      perform these same functions.&#xD;
&#xD;
      Therefore, the purpose of this study is to examine whether acute and short-term (1-week)&#xD;
      polyphenol supplementation in humans affects inflammation measured at the whole plasma level,&#xD;
      as well as the inflammatory and cholesterol efflux properties of HDL particles. The&#xD;
      investigators will test the effects of two supplements in a cross-over design: a curcumin&#xD;
      phytosome and a multi-polyphenol supplement (containing curcumin phytosome, quercetin&#xD;
      phytosome, and trans-resveratrol). The investigators hypothesize that one of the mechanisms&#xD;
      by which polyphenols exert a beneficial effect on inflammation and atherosclerosis is through&#xD;
      its modulation of HDL particles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Inflammation change: Whole plasma</measure>
    <time_frame>One hour</time_frame>
    <description>VCAM-1 and ICAM-1 expression in whole plasma will be measured at baseline, and one hour after a single dose of each supplement using flow cytometry. Differences in one-hour changes in inflammation between each supplement will be compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inflammation change: Whole plasma</measure>
    <time_frame>One week</time_frame>
    <description>VCAM-1 and ICAM-1 expression in whole plasma will be measured at baseline, and after one week of supplementation for each supplement using flow cytometry. Differences in one-week changes in inflammation between each supplement will be compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inflammation change: HDL plasma</measure>
    <time_frame>One hour</time_frame>
    <description>VCAM-1 and ICAM-1 expression in HDL plasma will be measured at baseline, and one hour after a single dose of each supplement using flow cytometry. Differences in one-hour changes in inflammation between each supplement will be compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inflammation change: HDL plasma</measure>
    <time_frame>One week</time_frame>
    <description>VCAM-1 and ICAM-1 expression in HDL plasma will be measured at baseline, and after one week of supplementation for each supplement using flow cytometry. Differences in one-week changes in inflammation between each supplement will be compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cholesterol efflux capacity</measure>
    <time_frame>Baseline, one hour, one week</time_frame>
    <description>HDL cholesterol efflux capacity will be measured at baseline, one hour after a single dose, and after a week of supplementation in non-apolipoprotein B containing plasma.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Inflammation</condition>
  <condition>Atherosclerosis</condition>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>PolyResveratrol Supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Curcumin Supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>PolyResveratrol Supplementation</intervention_name>
    <description>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).</description>
    <arm_group_label>PolyResveratrol Supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Curcumin Supplementation</intervention_name>
    <description>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).</description>
    <arm_group_label>Curcumin Supplementation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  General good health&#xD;
&#xD;
          -  Between 18 and 60 years old&#xD;
&#xD;
          -  Non-smoker&#xD;
&#xD;
          -  Not taking any medications or dietary supplements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking prescription anti-inflammatory drugs or supplements/drugs that may affect&#xD;
             inflammation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinical Exercise Research Center</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarah Schumacher</last_name>
      <phone>803-777-3331</phone>
      <email>dickeysc@mailbox.sc.edu</email>
    </contact>
    <investigator>
      <last_name>Mark Sarzynski, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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    <citation>Nicholls 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.</citation>
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    <citation>Boots 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.</citation>
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    <citation>Russo 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.</citation>
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    <citation>Ferrero 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.</citation>
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    <citation>Binion 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.</citation>
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    <citation>Kleemann R, Verschuren L, Morrison M, Zadelaar S, van Erk MJ, Wielinga PY, Kooistra T. Anti-inflammatory, anti-proliferative and anti-atherosclerotic effects of quercetin in human in vitro and in vivo models. Atherosclerosis. 2011 Sep;218(1):44-52. doi: 10.1016/j.atherosclerosis.2011.04.023. Epub 2011 May 5.</citation>
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    <citation>Berrougui H, Grenier G, Loued S, Drouin G, Khalil A. A new insight into resveratrol as an atheroprotective compound: inhibition of lipid peroxidation and enhancement of cholesterol efflux. Atherosclerosis. 2009 Dec;207(2):420-7. doi: 10.1016/j.atherosclerosis.2009.05.017. Epub 2009 May 22.</citation>
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    <citation>Voloshyna I, Hai O, Littlefield MJ, Carsons S, Reiss AB. Resveratrol mediates anti-atherogenic effects on cholesterol flux in human macrophages and endothelium via PPARgamma and adenosine. Eur J Pharmacol. 2013 Jan 5;698(1-3):299-309. doi: 10.1016/j.ejphar.2012.08.024. Epub 2012 Oct 4.</citation>
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    <citation>Chang YC, Lee TS, Chiang AN. Quercetin enhances ABCA1 expression and cholesterol efflux through a p38-dependent pathway in macrophages. J Lipid Res. 2012 Sep;53(9):1840-50. doi: 10.1194/jlr.M024471. Epub 2012 Jun 18.</citation>
    <PMID>22711909</PMID>
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    <citation>Cuomo J, Appendino G, Dern AS, Schneider E, McKinnon TP, Brown MJ, Togni S, Dixon BM. Comparative absorption of a standardized curcuminoid mixture and its lecithin formulation. J Nat Prod. 2011 Apr 25;74(4):664-9. doi: 10.1021/np1007262. Epub 2011 Mar 17.</citation>
    <PMID>21413691</PMID>
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    <citation>Jager R, Lowery RP, Calvanese AV, Joy JM, Purpura M, Wilson JM. Comparative absorption of curcumin formulations. Nutr J. 2014 Jan 24;13:11. doi: 10.1186/1475-2891-13-11.</citation>
    <PMID>24461029</PMID>
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    <citation>Gordon SM, Deng J, Lu LJ, Davidson WS. Proteomic characterization of human plasma high density lipoprotein fractionated by gel filtration chromatography. J Proteome Res. 2010 Oct 1;9(10):5239-49. doi: 10.1021/pr100520x.</citation>
    <PMID>20718489</PMID>
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    <citation>Cockerill GW, Rye KA, Gamble JR, Vadas MA, Barter PJ. High-density lipoproteins inhibit cytokine-induced expression of endothelial cell adhesion molecules. Arterioscler Thromb Vasc Biol. 1995 Nov;15(11):1987-94. doi: 10.1161/01.atv.15.11.1987.</citation>
    <PMID>7583580</PMID>
  </reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>October 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>November 13, 2017</last_update_submitted>
  <last_update_submitted_qc>November 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inflammation</keyword>
  <keyword>HDL</keyword>
  <keyword>Anti-inflammatory</keyword>
  <keyword>Supplementation</keyword>
  <keyword>Curcumin</keyword>
  <keyword>polyphenol</keyword>
  <keyword>V-cam</keyword>
  <keyword>I-cam</keyword>
  <keyword>atherosclerosis</keyword>
  <keyword>cardiovascular disease</keyword>
  <keyword>atherogenesis</keyword>
  <keyword>antioxidant</keyword>
  <keyword>resveratrol</keyword>
  <keyword>quercetin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Curcumin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 12, 2020</submitted>
    <returned>December 7, 2020</returned>
    <submitted>February 8, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02998918
org study id: COBRE PSI
nct id: NCT02998918
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Inflammation change: Whole plasma
time frame: One hour
description: VCAM-1 and ICAM-1 expression in whole plasma will be measured at baseline, and one hour after a single dose of each supplement using flow cytometry. Differences in one-hour changes in inflammation between each supplement will be compared.
measure: Inflammation change: Whole plasma
time frame: One week
description: VCAM-1 and ICAM-1 expression in whole plasma will be measured at baseline, and after one week of supplementation for each supplement using flow cytometry. Differences in one-week changes in inflammation between each supplement will be compared.
measure: Inflammation change: HDL plasma
time frame: One hour
description: VCAM-1 and ICAM-1 expression in HDL plasma will be measured at baseline, and one hour after a single dose of each supplement using flow cytometry. Differences in one-hour changes in inflammation between each supplement will be compared.
measure: Inflammation change: HDL plasma
time frame: One week
description: VCAM-1 and ICAM-1 expression in HDL plasma will be measured at baseline, and after one week of supplementation for each supplement using flow cytometry. Differences in one-week changes in inflammation between each supplement will be compared.
measure: Cholesterol efflux capacity
time frame: Baseline, one hour, one week
description: HDL cholesterol efflux capacity will be measured at baseline, one hour after a single dose, and after a week of supplementation in non-apolipoprotein B containing plasma.
arm group label: PolyResveratrol Supplementation
arm group type: Experimental
description: 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.
arm group label: Curcumin Supplementation
arm group type: Experimental
description: 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.
intervention type: Dietary Supplement
intervention name: PolyResveratrol Supplementation
description: 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).
arm group label: PolyResveratrol Supplementation
intervention type: Dietary Supplement
intervention name: Curcumin Supplementation
description: 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).
arm group label: Curcumin Supplementation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
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responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Atherosclerosis
mesh term: Inflammation
mesh term: Curcumin
sharing ipd: No
submitted: November 12, 2020
returned: December 7, 2020
submitted: February 8, 2023