NCT05542394

Brief Summary

This pilot study aims to investigate the pharmacokinetics of a novel curcuminoid preparation with suggested high bioavailability due to its solubility in water, compared to two standard hydrophobic formulations. The findings of this study will help the health care providers and community to select suitable formulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 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

First Submitted

Initial submission to the registry

September 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2023

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

September 12, 2022

Last Update Submit

August 27, 2023

Conditions

Plasma Levels of Different Curcuminoids Preparations

Keywords

Curcumin H2O, Tumeric, piperine

Outcome Measures

Primary Outcomes (7)

  • Blood concentration of bisdemethoxycurcumin

    plasma bisdemethoxycurcumin levels using LC MS/MS

    [Time Frame: Change during 8 hours]

  • Blood concentration of desmethoxycurcumin

    plasma desmethoxycurcumin levels using LC MS/MS

    [Time Frame: Change during 8 hours]

  • Blood concentration of piperine-curcuminoids

    plasma piperine-curcuminoids levels using LC MS/MS

    [Time Frame: Change during 8 hours]

  • Blood concentration of hexahydrocurcumin

    plasma hexahydrocurcumin levels using LC MS/MS

    [Time Frame: Change during 8 hours]

  • Blood concentration of curcumin diethyl disuccinate

    plasma curcumin diethyl disuccinate levels using LC MS/MS

    [Time Frame: Change during 8 hours]

  • Blood concentration of tetrahydrocurcumin

    plasma tetrahydrocurcumin levels using LC MS/MS

    [Time Frame: Change during 8 hours]

  • Blood concentration of curcumin

    plasma curcumin levels using LC MS/MS

    [Time Frame: Change during 8 hours]

Study Arms (3)

Curcumin H2O SAP

EXPERIMENTAL

Water soluble version of turmeric extract standardized to 10% curcuminoids will be administered orally (1 dose)

Dietary Supplement: Curcumin

Tumeric with piperine SAP

ACTIVE COMPARATOR

Turmeric extract standardized to 95% curcuminoids in combination with 5 mg of piperine per capsule will be administered orally (1 dose)

Dietary Supplement: Curcumin

Tumeric without piperine

PLACEBO COMPARATOR

Turmeric extract standardized to 95% curcuminoids without piperine will be administered orally (1 dose)

Dietary Supplement: Curcumin

Interventions

CurcuminDIETARY_SUPPLEMENT

water soluble version of turmeric extract standardized to 10% curcuminoids .

Also known as: NFH
Curcumin H2O SAPTumeric with piperine SAPTumeric without piperine

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female Apparently healthy adults

You may not qualify if:

  • Postmenopausal women Smokers Overweight Chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Jordan

Amman, Jordan

Location

Related Publications (8)

  • Sahebkar A, Henrotin Y. Analgesic Efficacy and Safety of Curcuminoids in Clinical Practice: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Pain Med. 2016 Jun;17(6):1192-202. doi: 10.1093/pm/pnv024. Epub 2015 Dec 14.

    PMID: 26814259BACKGROUND

  • Schiborr C, Kocher A, Behnam D, Jandasek J, Toelstede S, Frank J. The oral bioavailability of curcumin from micronized powder and liquid micelles is significantly increased in healthy humans and differs between sexes. Mol Nutr Food Res. 2014 Mar;58(3):516-27. doi: 10.1002/mnfr.201300724. Epub 2014 Jan 9.

    PMID: 24402825BACKGROUND

  • Kocher A, Bohnert L, Schiborr C, Frank J. Highly bioavailable micellar curcuminoids accumulate in blood, are safe and do not reduce blood lipids and inflammation markers in moderately hyperlipidemic individuals. Mol Nutr Food Res. 2016 Jul;60(7):1555-63. doi: 10.1002/mnfr.201501034. Epub 2016 May 23.

    PMID: 26909743BACKGROUND

  • Fanca-Berthon P, Tenon M, Bouter-Banon SL, Manfre A, Maudet C, Dion A, Chevallier H, Laval J, van Breemen RB. Pharmacokinetics of a Single Dose of Turmeric Curcuminoids Depends on Formulation: Results of a Human Crossover Study. J Nutr. 2021 Jul 1;151(7):1802-1816. doi: 10.1093/jn/nxab087.

    PMID: 33877323BACKGROUND

  • Kocher A, Schiborr C, Behnam D, Frank J: The oral bioavailability of curcuminoids in healthy humans is markedly enhanced by micellar solubilisation but not further improved by simultaneous ingestion of sesamin, ferulic acid, naringenin and xanthohumol.Journal of functional foods 2015, 14:183-191.

    BACKGROUND

  • Baum L, Cheung SK, Mok VC, Lam LC, Leung VP, Hui E, Ng CC, Chow M, Ho PC, Lam S, Woo J, Chiu HF, Goggins W, Zee B, Wong A, Mok H, Cheng WK, Fong C, Lee JS, Chan MH, Szeto SS, Lui VW, Tsoh J, Kwok TC, Chan IH, Lam CW. Curcumin effects on blood lipid profile in a 6-month human study. Pharmacol Res. 2007 Dec;56(6):509-14. doi: 10.1016/j.phrs.2007.09.013. Epub 2007 Sep 18.

    PMID: 17951067BACKGROUND

  • Carroll RE, Benya RV, Turgeon DK, Vareed S, Neuman M, Rodriguez L, Kakarala M, Carpenter PM, McLaren C, Meyskens FL Jr, Brenner DE. Phase IIa clinical trial of curcumin for the prevention of colorectal neoplasia. Cancer Prev Res (Phila). 2011 Mar;4(3):354-64. doi: 10.1158/1940-6207.CAPR-10-0098.

    PMID: 21372035BACKGROUND

  • Dhillon N, Aggarwal BB, Newman RA, Wolff RA, Kunnumakkara AB, Abbruzzese JL, Ng CS, Badmaev V, Kurzrock R. Phase II trial of curcumin in patients with advanced pancreatic cancer. Clin Cancer Res. 2008 Jul 15;14(14):4491-9. doi: 10.1158/1078-0432.CCR-08-0024.

    PMID: 18628464BACKGROUND

MeSH Terms

Interventions

Curcumin

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 15, 2022

Study Start

September 20, 2022

Primary Completion

April 6, 2023

Study Completion

April 30, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

JO(1)