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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation T24H

Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene

There are 3 clinical trials

Clinical Trials


1 Real Time Continuous Glucose Monitoring With Glucoday® as an Assistant for Intensive Insulin Therapy in Diabetic Cardiothoracic Surgery Patients: a Randomized Study Comparing Blood Glucose Measurements Alone or Associated to Continue Glucose Monitoring

An increased risk of adverse outcome is noted for diabetic patients admitted in surgery intensive care units (ICU). Tight glycemic control with intensive insulin therapy dramatically reduces in-hospital mortality and adverse outcome. Devices recording continuously interstitial glucose monitoring (CGM) may be an aid in patients of ICU in whom normoglycemia become a target. The mini-invasive device (Glucoday®) should provide real-time glucose concentrations in order to quickly adjust insulin infusion rates. The objective of MARGE study is to compare percent of time in normoglycemia based on conventional monitoring (discontinuous glucose monitoring) and Glucoday to conventional monitoring alone. The MARGE study is a multicenter (2 centers), randomized, single blind trial. Several studies have shown that hyperglycemia is associated with poor outcomes in hospitalized patients. Postoperative glucose levels are a significant predictor of infection rates after cardiac surgery and death rate. Based on these observational studies, a randomized controlled intervention trial in surgical ICU patients demonstrated that intensive insulin therapy reduced the overall in-hospital mortality by 34 % and stream infection by 46 %. Using continuous glycemic monitoring (CGM) it has been shown that intensive insulin therapy based on discontinuous glucose monitoring revealed that normoglycemia is achieved only 22 % of time. The researchers' aim is to determine if real time CGM with a new generation mini invasive device, Glucoday® S, would allow quickly adjusting insulin infusions rates according to interstitial glucose levels and decreasing both hyperglycemic and hypoglycemic excursions. This study will further investigate whether application of real time CGM to titrate insulin therapy to target glycemia in a tight range (80-110 mg/dl) can improve diabetic patient outcome after coronary artery bypass grafting (CABG).

NCT00878891
Conditions
  1. Diabetes
Interventions
  1. Device: Continuous glucose monitoring for immediate correction of abnormal glycemia

3: agreement between CGM with Glucoday® and conventional capillary blood glucose monitoring using coupled data recorded at the same time except couples of data corresponding to calibration time (T0, T24H). --- T24H ---

Primary Outcomes

Measure: Percent of time in normoglycemia (0.8 - 1.10 g/L)

Time: Between the hour of the end of the intervention (CABG) and T48 hours after the first calibration of the Glucoday or while battery last

Secondary Outcomes

Measure: Percent of post CABG time in hyperglycemia (>1.8 g/l) and hypoglycemia (<0.5 g/l)

Time: Between the hour of the end of the intervention (CABG) and T48 hours after the first calibration of the Glucoday or while battery last

Measure: Clinical outcomes incidence : death rate, cardiovascular events (acute coronary syndromes, heart failure, arrhythmia) stream infections, neurologic events

Time: during 30 days after CABG

Measure: Agreement between CGM with Glucoday and conventional capillary blood glucose monitoring in the setting of CABG and surgical ICU

Time: During 48 hours

Measure: During of stay in ICU and in tyhe surgical care unit

Time: During the hospitalisation

Measure: Adverse events due to the device

Time: During the hospitalization

2 Pharmacokinetics Study Assessing Bioavailability of Gingerols and Shogaols After Consumption of Five Ginger Extracts in Healthy Volunteers.

The objective of this study is to assess bioavailability of total gingeroids, free gingerols and shogaols, so as their glucuronide and sulfate metabolites, in the plasma, after consumption of a single dose of 5 different ginger extracts. These five extracts have the same quantity of active substance but with different titration (1.6%, 5%, 39%, 26% and 26% NOP80).

NCT03698318
Conditions
  1. Healthy Subject
Interventions
  1. Dietary Supplement: Tested product n°1
  2. Dietary Supplement: Tested product n°2
  3. Dietary Supplement: Tested product n°3
  4. Dietary Supplement: Tested product n°4
  5. Dietary Supplement: Tested product n°5

AUC of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations from 0 to 24 hours following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T24H. --- T24H ---

AUC of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10-gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations from 0 to 24 hours following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T24H. --- T24H ---

AUC of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10-gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations from 0 to infinity following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T24H. --- T24H ---

AUC of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations from 0 to infinity following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T24H. --- T24H ---

Primary Outcomes

Description: The primary endpoint is the AUC (Area Under the Curve) of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentration from 0 to 8 hours (AUC0-8h) following consumption of ginger extract (expressed in µg.h/mL) and considering the following time-points: T0 to T480. The primary comparisons are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg and Gingest TM 26% versus Ginger 1.6% 28.9 mg.

Measure: AUC of total gingeroids plasmatic concentration

Time: From 0 to 8 hours

Secondary Outcomes

Description: AUC of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations from 0 to 8 hours following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T480. Secondary comparisons are GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg

Measure: AUC0-8H of total gingeroids plasmatic concentration

Time: From 0 to 8 hours

Description: AUC of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10-gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations from 0 to 8 hours following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T480. Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg

Measure: AUC0-8H of each analytes of ginger plasmatic concentration separately

Time: From 0 to 8 hours

Description: AUC of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations from 0 to 24 hours following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T24H. Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg

Measure: AUC0-24H of each total gingeroids plasmatic concentrations

Time: From 0 to 24 hours

Description: AUC of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10-gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations from 0 to 24 hours following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T24H. Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg

Measure: AUC0-24H of each analytes of ginger plasmatic concentration separately

Time: From 0 to 24 hours

Description: AUC of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10-gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations from 0 to infinity following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T24H. Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg

Measure: AUC0-∞ of each analytes of ginger plasmatic concentration separately

Time: From 0 to infinity

Description: AUC of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations from 0 to infinity following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T24H. Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg

Measure: AUC0-∞ of total gingeroids plasmatic concentrations

Time: From 0 to infinity

Description: Half-life time of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations following consumption of each test product (expressed in minutes). Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg

Measure: Half-life time of total gingeroids plasmatic concentrations

Time: 24 hours

Description: Half-life time of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10- gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate plasmatic concentrations following consumption of each test product (expressed in minutes). Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg

Measure: Half-life time of each analytes of ginger plasmatic concentration separately

Time: 24 hours

Description: Terminal elimination rate constant of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10- gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations following consumption of each test product. Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg

Measure: Terminal elimination rate constant of each analytes of ginger plasmatic concentration separately

Time: 24 hours

Description: Terminal elimination rate constant of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations following consumption of each test product. Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg

Measure: Terminal elimination rate constant of total gingeroids plasmatic concentrations

Time: 24 hours

Description: Time to peak of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations following consumption of each test product (expressed in minutes). Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg

Measure: Time to peak of total gingeroids plasmatic concentrations

Time: 24 hours

Description: Time to peak of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10-gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations following consumption of each test product (expressed in minutes). Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg

Measure: Time to peak of each analytes of ginger plasmatic concentration

Time: 24 hours

Description: Peak of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10-gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations following consumption of each test product (expressed in µg/mL). Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg

Measure: Peak of each analytes of ginger plasmatic concentration

Time: 24 hours

Description: Peak of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations following consumption of each test product (expressed in µg/mL). Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg

Measure: Peak of total gingeroids plasmatic concentrations

Time: 24 hours

3 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
Conditions
  1. Healthy
Interventions
  1. Dietary Supplement: TG
  2. Dietary Supplement: STE
  3. Dietary Supplement: NOV
  4. Dietary Supplement: PHYT
  5. Dietary Supplement: TEP

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 ---

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


HPO Nodes