SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03621865

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Comparative Pharmacokinetic Study in Healthy Volunteers to Evaluate the Ability of TURMIPURE GOLD Formulation to Enhance the Bioavailability of Curcuminoids

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.

NCT03621865 Healthy

5 Interventions

Name: TG

Description: Turmipure GOLD™ 30% curcuminoids (300 mg)

Type: Dietary Supplement

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

Name: STE

Description: Standard turmeric powder extract 95% curcuminoids (1500 mg)

Type: Dietary Supplement

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

Name: NOV

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

Type: Dietary Supplement

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

Name: PHYT

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

Type: Dietary Supplement

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

Name: TEP

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

Type: Dietary Supplement

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


Primary Outcomes

Description: 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.

Measure: Dose-normalized AUC of total curcuminoids plasmatic concentration

Time: from 0 to 24 hours

Secondary Outcomes

Description: AUC of total curcuminoids plasmatic concentration from 0 to 24 hours (AUC0-24h, expressed in µg.h/mL);

Measure: AUC of total curcuminoids plasmatic concentration

Time: from 0 to 24 hours

Description: AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations from 0 to 24 hours (AUC0-24h, expressed in µg.h/mL);

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

Time: from 0 to 24 hours

Description: AUC of curcuminoids metabolites plasmatic concentrations from 0 to 24 hours (AUC0-24h, expressed in µg.h/mL);

Measure: AUC of curcuminoids metabolites plasmatic concentrations

Time: from 0 to 24 hours

Description: AUC of total curcuminoids plasmatic concentration from 0 to 8 hours normalized to curcuminoids intake (AUC0-8h/dose, expressed in µg.h/mL/mg);

Measure: AUC of total curcuminoids plasmatic concentration normalized to curcuminoids intake

Time: from 0 to 8 hours

Description: AUC of total curcuminoids plasmatic concentration from 0 to 8 hours (AUC0-8h) (expressed in µg.h/mL);

Measure: AUC of total curcuminoids plasmatic concentration

Time: from 0 to 8 hours

Description: AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations from 0 to 8 hours (AUC0-8h, expressed in µg.h/mL);

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

Time: from 0 to 8 hours

Description: AUC of curcuminoids metabolites plasmatic concentrations from 0 to 8 hours (AUC0-8h, expressed in µg.h/mL);

Measure: AUC of curcuminoids metabolites plasmatic concentrations

Time: from 0 to 8 hours

Description: AUC of total curcuminoids plasmatic concentration from 0 to infinity normalized to curcuminoids intake (AUC0-infinity/dose, expressed in µg.h/mL/mg);

Measure: AUC of total curcuminoids plasmatic concentration normalized to curcuminoids intake

Time: from 0 to infinity

Description: AUC of total curcuminoids plasmatic concentration from 0 to infinity (AUC0-infinity, expressed in µg.h/mL);

Measure: AUC of total curcuminoids plasmatic concentration

Time: from 0 to infinity

Description: AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations from 0 to infinity (AUC0-infinity, expressed in µg.h/mL);

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

Time: from 0 to infinity

Description: AUC of curcuminoidsmetabolites plasmatic concentrations from 0 to infinity (AUC0-infinity, expressed in µg.h/mL);

Measure: AUC of curcuminoids metabolites plasmatic concentrations

Time: from 0 to infinity

Description: Peak of total curcuminoids plasmatic concentration normalized to curcuminoids intake (Cmax/dose, expressed in µg/mL/mg);

Measure: Peak of total curcuminoids plasmatic concentration normalized to curcuminoids intake

Time: 24hours

Description: Peak of total curcuminoids plasmatic concentration (Cmax, expressed in µg/mL);

Measure: Peak of total curcuminoids plasmatic concentration

Time: 24hours

Description: Peak of curcuminoids separately plasmatic concentrations (Cmax, expressed in µg/mL);

Measure: Peak of curcuminoids separately plasmatic concentrations

Time: 24hours

Description: Peak of curcuminoids metabolites plasmatic concentrations (Cmax, expressed in µg/mL);

Measure: Peak of curcuminoids metabolites plasmatic concentrations

Time: 24hours

Description: Half-life of total curcuminoids in plasma (t1/2, expressed in minutes);

Measure: Half-life of total curcuminoids in plasma

Time: 24hours

Description: Half-life of curcuminoids separately (curcumin, DMC, BDMC) in plasma (t1/2, expressed in minutes);

Measure: Half-life of curcuminoids separately (curcumin, DMC, BDMC) in plasma

Time: 24hours

Description: Half-life of curcuminoids metabolites in plasma (t1/2, expressed in minutes);

Measure: Half-life of curcuminoids metabolites in plasma

Time: 24hours

Description: Terminal elimination rate constant of total curcuminoids in plasma (λz);

Measure: Terminal elimination rate constant of total curcuminoids in plasma (λz)

Time: 24hours

Description: Terminal elimination rate constant curcuminoids separately (curcumin, DMC, BDMC) in plasma (λz);

Measure: Terminal elimination rate constant curcuminoids separately (curcumin, DMC, BDMC) in plasma (λz)

Time: 24hours

Description: Terminal elimination rate constant curcuminoids metabolites in plasma (λz);

Measure: Terminal elimination rate constant curcuminoids metabolites in plasma (λz)

Time: 24hours

Description: Time to peak of total curcuminoids plasmatic concentration in plasma (Tmax, expressed in minutes)

Measure: Time to peak of total curcuminoids plasmatic concentrations

Time: 24hours

Description: Time to peak of plasmatic concentrations curcuminoids separately (curcumin, DMC, BDMC) in plasma (Tmax, expressed in minutes);

Measure: Time to peak of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations

Time: 24hours

Description: Time to peak of plasmatic concentrations curcuminoids metabolites in plasma (Tmax, expressed in minutes);

Measure: Time to peak of curcuminoids metabolites plasmatic concentrations

Time: 24hours

Description: Relative bioavailability from 0 to 24 hours defined as the ratio of dose-normalized AUC0-24h of total curcuminoids for the different tested formulation to the dose-normalized AUC0-24h obtained for the reference product (turmeric extract 95% curcuminoids).

Measure: Relative bioavailability

Time: from 0 to 24 hours

Purpose: Basic Science

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 T24H

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. --- T24H ---



HPO Nodes