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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00317-34 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| BioFortis | OTHER |
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The goal of this clinical trial is to learn about the extent to which turmeric compounds in different food matrices becomes available to the body in healthy volunteers. The main question it aims to answer is:
Participants will ingest a turmeric dietary supplement as a capsule or in different food matrices on six testing days (separated by at least one week). The day before testing day, a standardized dinner will be provided to the participants in the evening and participants will be instructed to not consume any foods or beverages (except water) and to arrive fasted (12 hours) at the investigation site. Participants will ingest turmeric dietary supplement formulations one by one in random order in the morning of testing days. Regular blood and urine samples will be collected before and up to 24 hours after the turmeric dietary supplement ingestion. Standardized meals will be provided during the entire testing day (lunch, mid-afternoon snack, dinner).
Curcumin has been studied as the main bioactive component of the rhizome of the herb Curcuma longa, known as turmeric, and is associated to potential health effects and benefits. Other bioactive components have also been identified, called the curcuminoid group. Curcuminoids are natural yellow-orange pigments and hydrophobic polyphenols derived from. Extracts of turmeric generally contain 75-80% curcumin, 15-20% demethoxycurcumin (DMC), and 0-10% bisdemethoxycurcumin (BDMC). Curcumin and curcuminoids have been extensively investigated due to their antioxidant and anti-inflammatory properties, notably regarding their potential efficacy in modulating various health conditions.
In the present trial, the aim is to assess the bioavailability of curcuminoids in different food matrix formulations, the capsule format being the reference matrix, with a hypothesis of equivalence. The primary objective of the study is to assess the plasmatic concentration profile of total curcuminoids (curcumin, DMC, BDMC and their metabolites) on a 24-hour period after consumption of five different food matrix formulations containing TPG in comparison to the dietary supplement capsule formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence capsule - ready to drink - sport bar - dairy analog - gummies - probiotic drink | Experimental | Subjects receive Turmipure Gold® preparations in different food matrices in the following order: capsule - ready to drink - sport bar - dairy analog - gummies - probiotic drink |
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| Sequence dairy analog - probiotic drink - ready to drink - gummies - capsule - sport bar | Experimental | Subjects receive Turmipure Gold® preparations in different food matrices in the following order: dairy analog - probiotic drink - ready to drink - gummies - capsule - sport bar |
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| Sequence gummies - sport bar - probiotic drink - capsule - dairy analog - ready to drink | Experimental | Subjects receive Turmipure Gold® preparations in different food matrices in the following order: gummies - sport bar - probiotic drink - capsule - dairy analog - ready to drink |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPG capsule | Dietary Supplement | A dietary supplement product in capsule form containing 300 mg Turmipure Gold® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-normalized AUC0-24h of total curcuminoids | Normalized (according to mg of curcuminoids ingested) area under the concentration-time curve from 0 to 24 h of total curcuminoids (sum of all quantified metabolites) in plasma:
| 0 to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-normalized AUC0-24h of curcuminoid compounds and of their metabolites | Normalized (according to mg of curcuminoids ingested) area under the plasma concentration-time curve from 0 to 24 h of:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle Metreau, MD | BioFortis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis | Saint-Herblain | 44800 | France |
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Monocentric, randomized, cross-over, open-label, pharmacokinetic study
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| Sequence probiotic drink - gummies - dairy analog - sport bar - ready to drink - capsule |
| Experimental |
Subjects receive Turmipure Gold® preparations in different food matrices in the following order: probiotic drink - gummies - dairy analog - sport bar - ready to drink - capsule |
|
| Sequence ready to drink - dairy analog - capsule - probiotic drink - sport bar - gummies | Experimental | Subjects receive Turmipure Gold® preparations in different food matrices in the following order: ready to drink - dairy analog - capsule - probiotic drink - sport bar - gummies |
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| Sequence sport bar - capsule - gummies - ready to drink - probiotic drink - dairy analog | Experimental | Subjects receive Turmipure Gold® preparations in different food matrices in the following order: sport bar - capsule - gummies - ready to drink - probiotic drink - dairy analog |
|
| TPG ready to drink | Dietary Supplement | Ingredient stick containing 300 mg Turmipure Gold® mixed in 60 mL mango fruit nectar |
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| TPG dairy analog | Dietary Supplement | Ingredient stick containing 300 mg Turmipure Gold® mixed in 240 mL oat milk |
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| TPG probiotic drink | Dietary Supplement | Ingredient stick containing 300 mg Turmipure Gold® mixed in a 100 mL probiotic yogurt drink base |
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| TPG gummies | Dietary Supplement | Pectin gummies containing 300 mg Turmipure Gold® |
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| TPG sport bar | Dietary Supplement | Sport nutrition bar containing 300 mg Turmipure Gold® |
|
| 0 to 24 hours |
| Dose-normalized AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites | Normalized (according to mg of curcuminoids ingested) area under the plasma concentration-time curve from 0 to 8 h of:
| 0 to 8 hours |
| Dose-normalized AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites | Normalized (according to mg of curcuminoids ingested) area under the plasma concentration-time curve from 0 hours to extrapolated infinite time of:
| Data collected from 0 to 24 hours |
| AUC0-24h of total curcuminoids, curcuminoid compounds and of their metabolites | Area under the plasma concentration-time curve from 0 to 24 h of:
| 0 to 24 hours |
| AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites | Area under the plasma concentration-time curve from 0 to 8 h of:
| 0 to 8 hours |
| AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites | Area under the plasma concentration-time curve from 0 hours to extrapolated infinite time of:
| Data collected from 0 to 24 hours |
| Relative bioavailability for normalized AUC0-24h of total curcuminoids, curcuminoid compounds and of their metabolites | Relative bioavailability (ratio of the dose-normalized AUCs) in different food matrices versus capsule format of:
| 0 to 24 hours |
| Relative bioavailability for normalized AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites | Relative bioavailability (ratio of the dose-normalized AUCs) in different food matrices versus capsule format of:
| 0 to 8 hours |
| Relative bioavailability for normalized AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites | Relative bioavailability (ratio of the dose-normalized AUCs) in different food matrices versus capsule format of:
| Data collected from 0 to 24 hours |
| Cmax of total curcuminoids, curcuminoid compounds and of their metabolites | Peak plasma concentration of:
| 0 to 24 hours |
| Dose-normalized Cmax of total curcuminoids, curcuminoid compounds and of their metabolites | Normalized (according curcuminoids ingested) peak plasma concentration of:
| 0 to 24 hours |
| Half-life of total curcuminoids, curcuminoid compounds and of their metabolites | Time after which the plasma concentration decreased by half of:
| 0 to 24 hours |
| Tmax of total curcuminoids, curcuminoid compounds and of their metabolites | Time to peak plasma concentration of:
| 0 to 24 hours |