HealthyTURBIONCT03621865
A Comparative Pharmacokinetic Study to Evaluate the Ability of a New Formulation to Enhance Curcuminoids Bioavailability
A study testing TG, STE and NOV in people with Healthy, run by Givaudan France Naturals at 1 site in France.
Trial 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)). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TG, STE and NOV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jul 2018to 26 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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),
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- 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
Who cannot join
- 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,
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- 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
- Currently taking (and during the past 3 months) any prebiotics or probiotics supplementation from food or from dietary supplements
- With significant change in food habits or in physical activity in the 3 months before the V0 visit or not agreeing to keep them unchanged throughout the study,
- Trying to lose weight with a current or planned in the next 3 months specific diet (hyper or hypocaloric, vegan, vegetarian…) or exercice regimen
- With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator,
- Consuming more than 3 standard drinks of alcoholic beverage daily for men or 2 daily for women or not agreeing to keep his alcohol consumption habits unchanged throughout the study,
- Having a lifestyle deemed incompatible with the study according to the investigator including high level physical activity (defined as more than 10 hours of significant physical activity a week, walking excluded),
- Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
- Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros,
- Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,
- Presenting a psychological or linguistic incapability to sign the informed consent,
- Impossible to contact in case of emergency.
- After V0 biological analyses the subject will be considered as non-eligible to the study on the following criteria:
- Control record (Glycaemia, GGT, ASAT, ALAT, Urea, Creatinine and Complete blood count) with clinically significant abnormality according to the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
The rhizome of Curcuma longa (turmeric) is commonly used as a spice and for its medicinal proprieties traditionally in Asian countries. Turmeric has been studying in different therapeutic areas. Antioxidant, anti-inflammatory (respiratory system, joints and digestive), antimutagenic, antimicrobial, neurological disease, hepatoprotective and anticancer properties are supported by in vitro and in vivo data.
Curcumin has been studied as the main bioactive component of turmeric associated to its potential health effect. However, besides curcumin, others components have been identified (demethoxycurcumin DMC and bisdemethoxycurcumin BDMC); this group of coumpounds are named together "curcuminoids". Curcuminoids are natural yellow-orange pigments and hydrophobic polyphenols derived from the rhizome of the herb Curcuma longa. They are commonly isolated from the spice and food-coloring agent turmeric. Extracts of turmeric generally contain 75-80% curcumin, 15-20% DMC, and 0-10% BDMC. Regarding the intrinsic property, 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.
This leads to the conclusion that curcuminoids from turmeric extract have low bioavailability, which limits its use 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.
- Conditions
- Healthy
- Being tested
- TG, STE, NOV, PHYT, TEP
- Keywords
- bioavailability, pharmacokinetic study, curcuminoids, curcumin, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGDietary supplement
Also called Turmipure GOLD™
Turmipure GOLD™ 30% curcuminoids (300 mg)
STEDietary supplement
Also called Standard turmeric powder extract
Standard turmeric powder extract 95% curcuminoids (1500 mg)
NOVDietary supplement
Novasol® Liquid micellar formulation 6% curcuminoids (1000 mg)
PHYTDietary supplement
Meriva® Turmeric Phytosome formulation 20% curcuminoids (1000 mg)
TEPDietary supplement
Turmeric extract C3 complex® 95% curcuminoids (1500mg) + BioPerine® 95% piperine (15 mg)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: TG; Dietary Supplement: STE; Dietary Supplement: NOV; Dietary Supplement: PHYT; Dietary 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. Receives: Dietary Supplement: TG; Dietary Supplement: STE; Dietary Supplement: NOV; Dietary Supplement: PHYT; Dietary 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. Receives: Dietary Supplement: TG; Dietary Supplement: STE; Dietary Supplement: NOV; Dietary Supplement: PHYT; Dietary 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. Receives: Dietary Supplement: TG; Dietary Supplement: STE; Dietary Supplement: NOV; Dietary Supplement: PHYT; Dietary 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. Receives: Dietary Supplement: TG; Dietary Supplement: STE; Dietary Supplement: NOV; Dietary Supplement: PHYT; Dietary 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. Receives: Dietary Supplement: TG; Dietary Supplement: STE; Dietary Supplement: NOV; Dietary Supplement: PHYT; Dietary 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. Receives: Dietary Supplement: TG; Dietary Supplement: STE; Dietary Supplement: NOV; Dietary Supplement: PHYT; Dietary 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. Receives: Dietary Supplement: TG; Dietary Supplement: STE; Dietary Supplement: NOV; Dietary Supplement: PHYT; Dietary 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. Receives: Dietary Supplement: TG; Dietary Supplement: STE; Dietary Supplement: NOV; Dietary Supplement: PHYT; Dietary 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. Receives: Dietary Supplement: TG; Dietary Supplement: STE; Dietary Supplement: NOV; Dietary Supplement: PHYT; Dietary Supplement: TEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from 0 to 24 hours
Secondary outcomes (25)
AUC of total curcuminoids plasmatic concentration
AUC of total curcuminoids plasmatic concentration from 0 to 24 hours (AUC0-24h, expressed in µg.h/mL);
Measured: from 0 to 24 hours
AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations
AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations from 0 to 24 hours (AUC0-24h, expressed in µg.h/mL);
Measured: from 0 to 24 hours
AUC of curcuminoids metabolites plasmatic concentrations
AUC of curcuminoids metabolites plasmatic concentrations from 0 to 24 hours (AUC0-24h, expressed in µg.h/mL);
Measured: from 0 to 24 hours
AUC of total curcuminoids plasmatic concentration normalized to curcuminoids intake
AUC of total curcuminoids plasmatic concentration from 0 to 8 hours normalized to curcuminoids intake (AUC0-8h/dose, expressed in µg.h/mL/mg);
Measured: from 0 to 8 hours
AUC of total curcuminoids plasmatic concentration
AUC of total curcuminoids plasmatic concentration from 0 to 8 hours (AUC0-8h) (expressed in µg.h/mL);
Measured: from 0 to 8 hours
AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations
AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations from 0 to 8 hours (AUC0-8h, expressed in µg.h/mL);
Measured: from 0 to 8 hours
AUC of curcuminoids metabolites plasmatic concentrations
AUC of curcuminoids metabolites plasmatic concentrations from 0 to 8 hours (AUC0-8h, expressed in µg.h/mL);
Measured: from 0 to 8 hours
AUC of total curcuminoids plasmatic concentration normalized to curcuminoids intake
AUC of total curcuminoids plasmatic concentration from 0 to infinity normalized to curcuminoids intake (AUC0-infinity/dose, expressed in µg.h/mL/mg);
Measured: from 0 to infinity
AUC of total curcuminoids plasmatic concentration
AUC of total curcuminoids plasmatic concentration from 0 to infinity (AUC0-infinity, expressed in µg.h/mL);
Measured: from 0 to infinity
AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations
AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations from 0 to infinity (AUC0-infinity, expressed in µg.h/mL);
Measured: from 0 to infinity
AUC of curcuminoids metabolites plasmatic concentrations
AUC of curcuminoidsmetabolites plasmatic concentrations from 0 to infinity (AUC0-infinity, expressed in µg.h/mL);
Measured: from 0 to infinity
Peak of total curcuminoids plasmatic concentration normalized to curcuminoids intake
Peak of total curcuminoids plasmatic concentration normalized to curcuminoids intake (Cmax/dose, expressed in µg/mL/mg);
Measured: 24hours
Peak of total curcuminoids plasmatic concentration
Peak of total curcuminoids plasmatic concentration (Cmax, expressed in µg/mL);
Measured: 24hours
Peak of curcuminoids separately plasmatic concentrations
Peak of curcuminoids separately plasmatic concentrations (Cmax, expressed in µg/mL);
Measured: 24hours
Peak of curcuminoids metabolites plasmatic concentrations
Peak of curcuminoids metabolites plasmatic concentrations (Cmax, expressed in µg/mL);
Measured: 24hours
Half-life of total curcuminoids in plasma
Half-life of total curcuminoids in plasma (t1/2, expressed in minutes);
Measured: 24hours
Half-life of curcuminoids separately (curcumin, DMC, BDMC) in plasma
Half-life of curcuminoids separately (curcumin, DMC, BDMC) in plasma (t1/2, expressed in minutes);
Measured: 24hours
Half-life of curcuminoids metabolites in plasma
Half-life of curcuminoids metabolites in plasma (t1/2, expressed in minutes);
Measured: 24hours
Terminal elimination rate constant of total curcuminoids in plasma (λz)
Terminal elimination rate constant of total curcuminoids in plasma (λz);
Measured: 24hours
Terminal elimination rate constant curcuminoids separately (curcumin, DMC, BDMC) in plasma (λz)
Terminal elimination rate constant curcuminoids separately (curcumin, DMC, BDMC) in plasma (λz);
Measured: 24hours
Terminal elimination rate constant curcuminoids metabolites in plasma (λz)
Terminal elimination rate constant curcuminoids metabolites in plasma (λz);
Measured: 24hours
Time to peak of total curcuminoids plasmatic concentrations
Time to peak of total curcuminoids plasmatic concentration in plasma (Tmax, expressed in minutes)
Measured: 24hours
Time to peak of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations
Time to peak of plasmatic concentrations curcuminoids separately (curcumin, DMC, BDMC) in plasma (Tmax, expressed in minutes);
Measured: 24hours
Time to peak of curcuminoids metabolites plasmatic concentrations
Time to peak of plasmatic concentrations curcuminoids metabolites in plasma (Tmax, expressed in minutes);
Measured: 24hours
Relative bioavailability
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).
Measured: from 0 to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start26 Jul 2018
- Primary completion26 Oct 2018
- Study completion26 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This pharmacokinectic study is designed as a monocentric, randomized, cross-over, pilot and open clinical trial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Givaudan France Naturals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences
- Responsible party
- Sponsor
- Investigators
- Pascale Fança-Berthon, PhD, Study director, Naturex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621865
- Sponsor's protocol ID
- 2018_A01390-55
- Acronym
- TURBIO
- Status last verified
- Nov 2018
- First submitted
- 6 Aug 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33877323
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Pharmacokinetic Study in Healthy Volunteers to Evaluate the Ability of TURMIPURE GOLD Formulation to Enhance the Bioavailability of Curcuminoids
- ClinicalTrials.gov ID
- NCT03621865
- Acronym / sponsor ID
- TURBIO / 2018_A01390-55
- Conditions
- Healthy
- Keywords
- bioavailability, pharmacokinetic study, curcuminoids, curcumin, healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Givaudan France NaturalsIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The rhizome of Curcuma longa (turmeric) is commonly used as a spice and for its medicinal proprieties traditionally in Asian countries. Turmeric has been studying in different therapeutic areas. Antioxidant, anti-inflammatory (respiratory system, joints and digestive), antimutagenic, antimicrobial, neurological disease, hepatoprotective and anticancer properties are supported by in vitro and in vivo data.
Curcumin has been studied as the main bioactive component of turmeric associated to its potential health effect. However, besides curcumin, others components have been identified (demethoxycurcumin DMC and bisdemethoxycurcumin BDMC); this group of coumpounds are named together "curcuminoids". Curcuminoids are natural yellow-orange pigments and hydrophobic polyphenols derived from the rhizome of the herb Curcuma longa. They are commonly isolated from the spice and food-coloring agent turmeric. Extracts of turmeric generally contain 75-80% curcumin, 15-20% DMC, and 0-10% BDMC. Regarding the intrinsic property, 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.
This leads to the conclusion that curcuminoids from turmeric extract have low bioavailability, which limits its use 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 10
- Model description
- This pharmacokinectic study is designed as a monocentric, randomized, cross-over, pilot and open clinical trial
| Arm | Type | Receives |
|---|---|---|
| subject sequence 1 | Experimental | Dietary Supplement: TG, Dietary Supplement: STE, Dietary Supplement: NOV, Dietary Supplement: PHYT, Dietary Supplement: TEPsubject allocation sequence 1. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
| subject sequence 2 | Experimental | Dietary Supplement: TG, Dietary Supplement: STE, Dietary Supplement: NOV, Dietary Supplement: PHYT, Dietary Supplement: TEPsubject allocation sequence 2. IIntervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
| subject sequence 3 | Experimental | Dietary Supplement: TG, Dietary Supplement: STE, Dietary Supplement: NOV, Dietary Supplement: PHYT, Dietary Supplement: TEPsubject allocation sequence 3. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
| subject sequence 4 | Experimental | Dietary Supplement: TG, Dietary Supplement: STE, Dietary Supplement: NOV, Dietary Supplement: PHYT, Dietary Supplement: TEPsubject allocation sequence 4. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
| subject sequence 5 | Experimental | Dietary Supplement: TG, Dietary Supplement: STE, Dietary Supplement: NOV, Dietary Supplement: PHYT, Dietary Supplement: TEPsubject allocation sequence 5. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
| subject sequence 6 | Experimental | Dietary Supplement: TG, Dietary Supplement: STE, Dietary Supplement: NOV, Dietary Supplement: PHYT, Dietary Supplement: TEPsubject allocation sequence 6. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
| subject sequence 7 | Experimental | Dietary Supplement: TG, Dietary Supplement: STE, Dietary Supplement: NOV, Dietary Supplement: PHYT, Dietary Supplement: TEPsubject allocation sequence 7. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
| subject sequence 8 | Experimental | Dietary Supplement: TG, Dietary Supplement: STE, Dietary Supplement: NOV, Dietary Supplement: PHYT, Dietary Supplement: TEPsubject allocation sequence 8. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
| subject sequence 9 | Experimental | Dietary Supplement: TG, Dietary Supplement: STE, Dietary Supplement: NOV, Dietary Supplement: PHYT, Dietary Supplement: TEPsubject allocation sequence 9. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
| subject sequence 10 | Experimental | Dietary Supplement: TG, Dietary Supplement: STE, Dietary Supplement: NOV, Dietary Supplement: PHYT, Dietary Supplement: TEPsubject allocation sequence 10. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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),
Key exclusion criteria (28 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TGAlso: Turmipure GOLD™Turmipure GOLD™ 30% curcuminoids (300 mg) | Dietary supplement | subject sequence 1, subject sequence 10, subject sequence 2, subject sequence 3, subject sequence 4, subject sequence 5, subject sequence 6, subject sequence 7, subject sequence 8, subject sequence 9 |
| STEAlso: Standard turmeric powder extractStandard turmeric powder extract 95% curcuminoids (1500 mg) | Dietary supplement | subject sequence 1, subject sequence 10, subject sequence 2, subject sequence 3, subject sequence 4, subject sequence 5, subject sequence 6, subject sequence 7, subject sequence 8, subject sequence 9 |
| NOVNovasol® Liquid micellar formulation 6% curcuminoids (1000 mg) | Dietary supplement | subject sequence 1, subject sequence 10, subject sequence 2, subject sequence 3, subject sequence 4, subject sequence 5, subject sequence 6, subject sequence 7, subject sequence 8, subject sequence 9 |
| PHYTMeriva® Turmeric Phytosome formulation 20% curcuminoids (1000 mg) | Dietary supplement | subject sequence 1, subject sequence 10, subject sequence 2, subject sequence 3, subject sequence 4, subject sequence 5, subject sequence 6, subject sequence 7, subject sequence 8, subject sequence 9 |
| TEPTurmeric extract C3 complex® 95% curcuminoids (1500mg) + BioPerine® 95% piperine (15 mg) | Dietary supplement | subject sequence 1, subject sequence 10, subject sequence 2, subject sequence 3, subject sequence 4, subject sequence 5, subject sequence 6, subject sequence 7, subject sequence 8, subject sequence 9 |
Primary outcome
Dose-normalized AUC of total curcuminoids plasmatic concentration
Time frame: from 0 to 24 hours
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.
25 secondary outcomes
AUC of total curcuminoids plasmatic concentration
Time frame: from 0 to 24 hours
AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations
Time frame: from 0 to 24 hours
AUC of curcuminoids metabolites plasmatic concentrations
Time frame: from 0 to 24 hours
AUC of total curcuminoids plasmatic concentration normalized to curcuminoids intake
Time frame: from 0 to 8 hours
AUC of total curcuminoids plasmatic concentration
Time frame: from 0 to 8 hours
AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations
Time frame: from 0 to 8 hours
AUC of curcuminoids metabolites plasmatic concentrations
Time frame: from 0 to 8 hours
AUC of total curcuminoids plasmatic concentration normalized to curcuminoids intake
Time frame: from 0 to infinity
AUC of total curcuminoids plasmatic concentration
Time frame: from 0 to infinity
AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations
Time frame: from 0 to infinity
AUC of curcuminoids metabolites plasmatic concentrations
Time frame: from 0 to infinity
Peak of total curcuminoids plasmatic concentration normalized to curcuminoids intake
Time frame: 24hours
Peak of total curcuminoids plasmatic concentration
Time frame: 24hours
Peak of curcuminoids separately plasmatic concentrations
Time frame: 24hours
Peak of curcuminoids metabolites plasmatic concentrations
Time frame: 24hours
Half-life of total curcuminoids in plasma
Time frame: 24hours
Half-life of curcuminoids separately (curcumin, DMC, BDMC) in plasma
Time frame: 24hours
Half-life of curcuminoids metabolites in plasma
Time frame: 24hours
Terminal elimination rate constant of total curcuminoids in plasma (λz)
Time frame: 24hours
Terminal elimination rate constant curcuminoids separately (curcumin, DMC, BDMC) in plasma (λz)
Time frame: 24hours
Terminal elimination rate constant curcuminoids metabolites in plasma (λz)
Time frame: 24hours
Time to peak of total curcuminoids plasmatic concentrations
Time frame: 24hours
Time to peak of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations
Time frame: 24hours
Time to peak of curcuminoids metabolites plasmatic concentrations
Time frame: 24hours
Relative bioavailability
Time frame: from 0 to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Derived from this study: PubMed 33877323Fanca-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascale Fança-Berthon, PhD study director
Naturex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TG, STE and NOV in people with Healthy, run by Givaudan France Naturals at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-normalized AUC of total curcuminoids plasmatic concentration (time frame: from 0 to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03621865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.