NCT03621865

Brief Summary

The rhizome of Curcuma longa (turmeric) is commonly used as a spice and for its medicinal properties traditionally in Asian countries. Turmeric extract usually contains 95% curcuminoids with a specific ratio (approximately 75-80% curcumin, 15-20% demethoxycurcumin (DMC), and 0-10% bisdemethoxycurcumin (BDMC)). Curcuminoids have higher solubility in organic solvents than in water. As a consequence, curcuminoids have low aqueous solubility and poor gastrointestinal absorption. They also exhibit rapid metabolism and systemic elimination and are therefore known to have limited bioavailability, which limits the use of turmeric extract in general health care and as an adjunct in managing various diseases. In order to improve the bioavailability of curcumin, several approaches have been undertaken. The use of adjuvant like piperine that interferes with glucuronidation; liposomal curcumin, nanoparticles, phospholipid complex; and structural analogues of curcumin. Recently, Naturex has developed a dried emulsion formulation using a turmeric extract mixed together with a quillaja extract, sunflower oil and arabic gum. This formulation is highly dispersible in water and should therefore improve the bioavailability of curcuminoids. The aim of this study is to assess the bioavailability of curcuminoids and their metabolites after oral intake of 4 turmeric extract-based formulations in comparison to a standard unformulated turmeric extract.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable healthy

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

July 26, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2018

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

August 6, 2018

Last Update Submit

November 5, 2018

Conditions

Healthy

Keywords

bioavailabilitypharmacokinetic studycurcuminoidscurcuminhealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Dose-normalized AUC of total curcuminoids plasmatic concentration

    The primary endpoint is the dose-normalized AUC of total curcuminoids (sum of curcumin, DMC, BDMC and their metabolites) plasmatic concentration from 0 to 24 hours (AUC0-24h/dose) (expressed in µg.h/mL/mg). The dose-normalized AUC is the AUC normalized to curcuminoids intake by dividing the observed AUC by the corresponding curcuminoids dosage of each administration The following time-points are considered: T0, T15, T30, T45, T60, T90, T120, T240, T60, T480, T24H. T-10 will be considered as baseline value (T0) for AUC calculation. The primary comparison is Turmipure Gold 300 mg vs Standard turmeric 1500 mg powder extract.

    from 0 to 24 hours

Secondary Outcomes (25)

  • AUC of total curcuminoids plasmatic concentration

    from 0 to 24 hours

  • AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations

    from 0 to 24 hours

  • AUC of curcuminoids metabolites plasmatic concentrations

    from 0 to 24 hours

  • AUC of total curcuminoids plasmatic concentration normalized to curcuminoids intake

    from 0 to 8 hours

  • AUC of total curcuminoids plasmatic concentration

    from 0 to 8 hours

  • +20 more secondary outcomes

Study Arms (10)

subject sequence 1

EXPERIMENTAL

subject allocation sequence 1. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

Dietary Supplement: TGDietary Supplement: STEDietary Supplement: NOVDietary Supplement: PHYTDietary Supplement: TEP

subject sequence 2

EXPERIMENTAL

subject allocation sequence 2. IIntervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

Dietary Supplement: TGDietary Supplement: STEDietary Supplement: NOVDietary Supplement: PHYTDietary Supplement: TEP

subject sequence 3

EXPERIMENTAL

subject allocation sequence 3. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

Dietary Supplement: TGDietary Supplement: STEDietary Supplement: NOVDietary Supplement: PHYTDietary Supplement: TEP

subject sequence 4

EXPERIMENTAL

subject allocation sequence 4. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

Dietary Supplement: TGDietary Supplement: STEDietary Supplement: NOVDietary Supplement: PHYTDietary Supplement: TEP

subject sequence 5

EXPERIMENTAL

subject allocation sequence 5. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

Dietary Supplement: TGDietary Supplement: STEDietary Supplement: NOVDietary Supplement: PHYTDietary Supplement: TEP

subject sequence 6

EXPERIMENTAL

subject allocation sequence 6. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

Dietary Supplement: TGDietary Supplement: STEDietary Supplement: NOVDietary Supplement: PHYTDietary Supplement: TEP

subject sequence 7

EXPERIMENTAL

subject allocation sequence 7. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

Dietary Supplement: TGDietary Supplement: STEDietary Supplement: NOVDietary Supplement: PHYTDietary Supplement: TEP

subject sequence 8

EXPERIMENTAL

subject allocation sequence 8. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

Dietary Supplement: TGDietary Supplement: STEDietary Supplement: NOVDietary Supplement: PHYTDietary Supplement: TEP

subject sequence 9

EXPERIMENTAL

subject allocation sequence 9. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

Dietary Supplement: TGDietary Supplement: STEDietary Supplement: NOVDietary Supplement: PHYTDietary Supplement: TEP

subject sequence 10

EXPERIMENTAL

subject allocation sequence 10. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

Dietary Supplement: TGDietary Supplement: STEDietary Supplement: NOVDietary Supplement: PHYTDietary Supplement: TEP

Interventions

TGDIETARY_SUPPLEMENT

Turmipure GOLD™ 30% curcuminoids (300 mg)

Also known as: Turmipure GOLD™
subject sequence 1subject sequence 10subject sequence 2subject sequence 3subject sequence 4subject sequence 5subject sequence 6subject sequence 7subject sequence 8subject sequence 9
STEDIETARY_SUPPLEMENT

Standard turmeric powder extract 95% curcuminoids (1500 mg)

Also known as: Standard turmeric powder extract
subject sequence 1subject sequence 10subject sequence 2subject sequence 3subject sequence 4subject sequence 5subject sequence 6subject sequence 7subject sequence 8subject sequence 9
NOVDIETARY_SUPPLEMENT

Novasol® Liquid micellar formulation 6% curcuminoids (1000 mg)

subject sequence 1subject sequence 10subject sequence 2subject sequence 3subject sequence 4subject sequence 5subject sequence 6subject sequence 7subject sequence 8subject sequence 9
PHYTDIETARY_SUPPLEMENT

Meriva® Turmeric Phytosome formulation 20% curcuminoids (1000 mg)

subject sequence 1subject sequence 10subject sequence 2subject sequence 3subject sequence 4subject sequence 5subject sequence 6subject sequence 7subject sequence 8subject sequence 9
TEPDIETARY_SUPPLEMENT

Turmeric extract C3 complex® 95% curcuminoids (1500mg) + BioPerine® 95% piperine (15 mg)

subject sequence 1subject sequence 10subject sequence 2subject sequence 3subject sequence 4subject sequence 5subject sequence 6subject sequence 7subject sequence 8subject sequence 9

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 45 years (limits included),
  • BMI between 19 and 25 kg/m² (limits included),
  • Weight stable within ±3kg in the last three months,
  • With routine blood chemistry values within the normal range
  • For women: Non menopausal with the same reliable contraception since at least 3 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study (condom with spermicidal gel and estrogen/progestin combination contraception accepted) or menopausal without or with hormone replacement therapy (estrogenic replacement therapy begun from less than 3 months excluded),
  • Non smoking or with tobacco consumption ≤ 5 cigarettes / day and agreeing not to smoke during all experimental sessions (V1 to V5),
  • Agreeing not to consume food, drink and condiment containing curcumin, turmeric (curcuma longa Linn.) or curry for 1 week prior to and throughout the entire study,
  • Good general and mental health with in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination,
  • Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
  • Affiliated with a social security scheme,
  • Agreeing to be registered on the volunteers in biomedical research file

You may not qualify if:

  • Suffering from a metabolic or endocrine disorder such as diabetes, uncontrolled or controlled thyroidal trouble or other metabolic disorder,
  • Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, ongoing hepatic or biliary disorders, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease),
  • Suffering from liver diseases
  • Current disease states that are contraindicated to subjects with dietary supplementation: chronic diarrhea, constipation or abdominal pain, Inflammatory bowel diseases (Crohn's disease or ulcerative colitis), Cirrhosis, chronic laxatives use…,
  • Suffering from Irritable Bowel Syndrome (IBS) diagnosed by a medical doctor and treated with chronic medication,
  • Having medical history of current pathology which could affect the study results or expose the subject to an additional risk according to the investigator,
  • Recent gastroenteritis or food borne illness such as confirmed food poisoning (less than 1 month),
  • Who made a blood donation in the 3 months before the V0 visit or intending to make it within 3 months ahead,
  • With a low venous capital not allowing to perform kinetic of blood samples according to the investigator's opinion,
  • With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient and/or of the standard meals (gluten intolerance, celiac disease, etc….)
  • Pregnant or lactating women or intending to become pregnant within 3 months ahead,
  • Exhibiting alcohol or drug dependence
  • On any chronic drug treatment (for example anticoagulant, antihypertensive treatment, treatment thyroid, asthma treatment, anxiolytic, antidepressant, lipid-lowering treatment, corticosteroids, phlebotonic, veino-tonic, drug with impact on blood circulation …) excepting oral and local contraceptives,
  • Currently taking (and during the past 3 months) any supplementation from botanical origins
  • Having consumed curcumin-containing food supplements (curcumin, turmeric and curry) or foods (curcumin, turmeric, E100, and curry) defined as at least 3 times per week and for 2 weeks prior to testing
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biofortis Mérieux NutriSciences

Saint-Herblain, 44800, France

Location

Related Publications (1)

  • 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: 33877323DERIVED

MeSH Terms

Interventions

tetraethylpyrazine

Study Officials

  • Pascale Fança-Berthon, PhD

    Naturex

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: This pharmacokinectic study is designed as a monocentric, randomized, cross-over, pilot and open clinical trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 9, 2018

Study Start

July 26, 2018

Primary Completion

October 26, 2018

Study Completion

October 26, 2018

Last Updated

November 6, 2018

Record last verified: 2018-11

Locations

FR(1)