Determination of Pharmacokinetics of Different Curcuminoids Preparations: Pilot Study

NCT ID: NCT05542394

Last Updated: 2023-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-20

Study Completion Date

2023-04-30

Brief Summary

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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.

Detailed Description

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This pilot study is the first phase that must be followed, in the second phase, by longer clinical trials to support the findings and investigate the role of the novel preparation on health.The second phase will include an assessment of the effectiveness of several doses of curcumin preparation on health as well as an evaluation of the tolerance and possible adverse effects. The latter could not be evaluated at this stage of a single dose.

Conditions

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Plasma Levels of Different Curcuminoids Preparations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Curcumin H2O SAP

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

Group Type EXPERIMENTAL

Curcumin

Intervention Type DIETARY_SUPPLEMENT

water soluble version of turmeric extract standardized to 10% curcuminoids

.

Tumeric with piperine SAP

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

Group Type ACTIVE_COMPARATOR

Curcumin

Intervention Type DIETARY_SUPPLEMENT

water soluble version of turmeric extract standardized to 10% curcuminoids

.

Tumeric without piperine

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

Group Type PLACEBO_COMPARATOR

Curcumin

Intervention Type DIETARY_SUPPLEMENT

water soluble version of turmeric extract standardized to 10% curcuminoids

.

Interventions

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Curcumin

water soluble version of turmeric extract standardized to 10% curcuminoids

.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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NFH

Eligibility Criteria

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Inclusion Criteria

Male and female Apparently healthy adults

Exclusion Criteria

Postmenopausal women Smokers Overweight Chronic diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nutritional Fundamentals for Health

UNKNOWN

Sponsor Role collaborator

University of Jordan

OTHER

Sponsor Role lead

Responsible Party

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Shatha Hammad, Assistant Professor

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The University of Jordan

Amman, , Jordan

Site Status

Countries

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Jordan

References

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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.

Reference Type BACKGROUND
PMID: 26814259 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24402825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26909743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33877323 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 17951067 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21372035 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18628464 (View on PubMed)

Other Identifiers

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10-2022/13342

Identifier Type: -

Identifier Source: org_study_id

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