NCT02998918

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

October 18, 2016

Results QC Date

November 12, 2020

Last Update Submit

November 16, 2023

Conditions

Keywords

InflammationHDLAnti-inflammatorySupplementationCurcuminpolyphenolV-camI-camatherosclerosiscardiovascular diseaseatherogenesisantioxidantresveratrolquercetin

Outcome Measures

Primary Outcomes (1)

  • 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.

    One week

Study Arms (2)

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.

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.

Dietary Supplement: Curcumin Supplementation

Interventions

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).

PolyResveratrol Supplementation
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).

Curcumin Supplementation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • General good health
  • Between 18 and 60 years old
  • Non-smoker
  • Not taking any medications or dietary supplements

You may not qualify if:

  • Taking prescription anti-inflammatory drugs or supplements/drugs that may affect inflammation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Exercise Research Center

Columbia, South Carolina, 29201, United States

Location

Related Publications (24)

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    PMID: 15486323BACKGROUND
  • 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.

    PMID: 16904539BACKGROUND
  • Bisht 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.

    PMID: 19903510BACKGROUND
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    PMID: 18324353BACKGROUND
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    PMID: 18370854BACKGROUND
  • Smoliga 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.

    PMID: 21688389BACKGROUND
  • Tome-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.

    PMID: 23448440BACKGROUND
  • 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.

    PMID: 18417116BACKGROUND
  • 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.

    PMID: 21856292BACKGROUND
  • 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.

    PMID: 9846848BACKGROUND
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    PMID: 19520742BACKGROUND
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    PMID: 21601209BACKGROUND
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    PMID: 19552907BACKGROUND
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    PMID: 23041272BACKGROUND
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    PMID: 26471308BACKGROUND
  • 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.

    PMID: 22711909BACKGROUND
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    PMID: 21413691BACKGROUND
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    PMID: 24461029BACKGROUND
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    PMID: 7583580BACKGROUND

MeSH Terms

Conditions

InflammationAtherosclerosisCardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Limitations and Caveats

The planned assays did not work in the stored specimens. Thus, data will not be reported for this trial

Results Point of Contact

Title
Mark Sarzynski
Organization
University of South Carolina

Study Officials

  • Mark Sarzynski

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 18, 2016

First Posted

December 21, 2016

Study Start

September 1, 2016

Primary Completion

July 1, 2017

Study Completion

June 1, 2020

Last Updated

November 18, 2023

Results First Posted

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations