CompletedNCT06300021Updated Mar 8, 2024

Bioavailability of Curcuminoids From Turmipure Gold® in Different Food Matrices

An interventional study of TPG capsule and TPG ready to drink in Healthy, sponsored by Givaudan France Naturals. Completed at 1 site in France. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-08.

Sponsored by Givaudan France Naturals · Not applicable, Interventional, and Basic science

From the registry’s dates

Registered 2 years 4 months after the study started (first participant enrolled Sep 2021, registered Feb 2024).

Phase: Not applicable
Study type: Interventional
Enrollment: 35
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study summary

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:

Is the availability to the body of a turmeric dietary supplement altered when consumed in fruit nectar, oat milk, yogurt drink, or gummies in comparison to a dietary supplement capsule?

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).

Read the detailed description

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.

Conditions studied

Healthy

Keywords

Turmeric
Curcuminoids
Curcumin
Bioavailability
Pharmacokinetics

In context

Lead sponsor

Givaudan France Naturals is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Age between 18 and 45 years (limits included)
BMI between 18.5 and 24.9 kg/m² (limits included)
Weight stable within ±3 kg 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 or menopausal without or with hormone replacement therapy since at least 3 months
Non-smoking or with tobacco consumption ≤5 cigarettes per day and agreeing not to smoke during the entire duration of the study
Good general and mental health 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 dated and signed informed consent form
Affiliated with a social security scheme
Agreeing to be registered on the volunteers in biomedical research file

Exclusion criteria

Exclusion Criteria:

Suffering from a metabolic or endocrine disorder such as diabetes, uncontrolled or controlled thyroidal trouble or other metabolic disorder
Suffering from a chronic disease (e.g. cancer, HIV, kidney failure, ongoing hepatic or biliary disorders, chronic inflammatory digestive disease, arthritis, anemia or other chronic respiratory trouble, gammapathies, hepatic diseases, decompensated diabetes, tuberculosis, ulcerative colitis, parkinson's disease, 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
Having medical history of current pathology which could affect the study results or expose the subject to an additional risk according to the investigator (IBS, chronic diarrhea, constipation or abdominal pain, inflammatory bowel diseases (Crohn's disease or ulcerative colitis), cirrhosis, chronic laxatives use, severe COVID-19 history (requiring oxygen-therapy) in the 12 past months, ...)
Recent gastroenteritis or food borne illness such as confirmed food poisoning (less than 1 month)
With a low venous capital of blood samples according to the investigator's opinion
With a known or suspected allergy or intolerance to any food
With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient or turmeric and/or of the standard meals
Pregnant or lactating women or intending to become pregnant within 3 months ahead
Currently taking any chronic drug treatment (for example: antidiabetics, anticoagulant, antihypertensive treatment, treatment thyroid, asthma treatment, anxiolytic, antidepressant, lipid-lowering treatment, corticosteroids, phlebotonic, veinotonic, drug with impact on blood circulation, ...) except oral and local contraceptives,
Currently taking or having taken any supplementation from botanical origins or with curcumin in the previous 3 months before inclusion
Currently taking or having taken laxatives or antibiotics, in the previous 3 months before the V0 visit
Currently taking or having taken any prebiotics or probiotics supplementation from food or from dietary supplements in the previous 3 months before the V0 visit
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 exercise regimen
With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator
Exhibiting alcohol or consuming more than 3 standard drinks of alcoholic beverage daily for men or 2 daily for women or not agreeing to keep alcohol consumption habits unchanged throughout the study or drug dependence or exhibiting drug dependence
Having a lifestyle deemed incompatible with the study according to the investigator including high level physical activity (defined as more than 5 hours of significant physical activity a week, walking excluded)
Having taken part in another clinical trial in the previous 3 months 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 rights following administrative or judicial decision
Presenting a psychological or linguistic incapability to sign the informed consent
Impossible to contact in case of emergency
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
Made a blood donation in the 3 months before the V0 visit or intending to make it within 3 months ahead
After V0 biological analyses the subject will be considered as non-eligible to the study on the following criteria: Control record (glycaemia, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, GGT, ASAT, ALAT, urea, creatinine, total bilirubin and CBC) with clinically significant abnormality according to the investigator

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 35 participants (actual)

Study arms

Experimental
Sequence capsule - ready to drink - sport bar - dairy analog - gummies - probiotic drink
Subjects receive Turmipure Gold® preparations in different food matrices in the following order: capsule - ready to drink - sport bar - dairy analog - gummies - probiotic drink
Dietary Supplement: TPG capsule · Dietary Supplement: TPG ready to drink · Dietary Supplement: TPG dairy analog · Dietary Supplement: TPG probiotic drink · Dietary Supplement: TPG gummies · Dietary Supplement: TPG sport bar
Experimental
Sequence dairy analog - probiotic drink - ready to drink - gummies - capsule - sport bar
Subjects receive Turmipure Gold® preparations in different food matrices in the following order: dairy analog - probiotic drink - ready to drink - gummies - capsule - sport bar
Dietary Supplement: TPG capsule · Dietary Supplement: TPG ready to drink · Dietary Supplement: TPG dairy analog · Dietary Supplement: TPG probiotic drink · Dietary Supplement: TPG gummies · Dietary Supplement: TPG sport bar
Experimental
Sequence gummies - sport bar - probiotic drink - capsule - dairy analog - ready to drink
Subjects receive Turmipure Gold® preparations in different food matrices in the following order: gummies - sport bar - probiotic drink - capsule - dairy analog - ready to drink
Dietary Supplement: TPG capsule · Dietary Supplement: TPG ready to drink · Dietary Supplement: TPG dairy analog · Dietary Supplement: TPG probiotic drink · Dietary Supplement: TPG gummies · Dietary Supplement: TPG sport bar
Experimental
Sequence probiotic drink - gummies - dairy analog - sport bar - ready to drink - capsule
Subjects receive Turmipure Gold® preparations in different food matrices in the following order: probiotic drink - gummies - dairy analog - sport bar - ready to drink - capsule
Dietary Supplement: TPG capsule · Dietary Supplement: TPG ready to drink · Dietary Supplement: TPG dairy analog · Dietary Supplement: TPG probiotic drink · Dietary Supplement: TPG gummies · Dietary Supplement: TPG sport bar
Experimental
Sequence ready to drink - dairy analog - capsule - probiotic drink - sport bar - gummies
Subjects receive Turmipure Gold® preparations in different food matrices in the following order: ready to drink - dairy analog - capsule - probiotic drink - sport bar - gummies
Dietary Supplement: TPG capsule · Dietary Supplement: TPG ready to drink · Dietary Supplement: TPG dairy analog · Dietary Supplement: TPG probiotic drink · Dietary Supplement: TPG gummies · Dietary Supplement: TPG sport bar
Experimental
Sequence sport bar - capsule - gummies - ready to drink - probiotic drink - dairy analog
Subjects receive Turmipure Gold® preparations in different food matrices in the following order: sport bar - capsule - gummies - ready to drink - probiotic drink - dairy analog
Dietary Supplement: TPG capsule · Dietary Supplement: TPG ready to drink · Dietary Supplement: TPG dairy analog · Dietary Supplement: TPG probiotic drink · Dietary Supplement: TPG gummies · Dietary Supplement: TPG sport bar

Interventions

Dietary supplementTPG capsule
A dietary supplement product in capsule form containing 300 mg Turmipure Gold®
Dietary supplementTPG ready to drink
Ingredient stick containing 300 mg Turmipure Gold® mixed in 60 mL mango fruit nectar
Dietary supplementTPG dairy analog
Ingredient stick containing 300 mg Turmipure Gold® mixed in 240 mL oat milk
Dietary supplementTPG probiotic drink
Ingredient stick containing 300 mg Turmipure Gold® mixed in a 100 mL probiotic yogurt drink base
Dietary supplementTPG gummies
Pectin gummies containing 300 mg Turmipure Gold®
Dietary supplementTPG sport bar
Sport nutrition bar containing 300 mg Turmipure Gold®

What researchers measure

Primary outcomes

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: * Total curcuminoids = curcumin + demethoxycurcumin (DMC) + bisdemethoxycurcumin (BDMC) + tetrahydrocurcumin (THC) + hexahydrocurcumin (HHC) + curcumin glucuronide + DMC glucuronide + BDMC glucuronide + THC glucuronide + HHC glucuronide + curcumin sulfate + DMC sulfate + BDMC sulfate + THC sulfate + HHC sulfate
Time frame: 0 to 24 hours

Secondary outcomes

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: * Total parent compounds * Total sulfate metabolites * Total glucuronide metabolites * Total parent compounds and their relative sulfate and glucuronide metabolites * Curcumin and its relative sulfate and glucuronide metabolites * DMC and its relative sulfate and glucuronide metabolites * BDMC and its relative sulfate and glucuronide metabolites * Curcumin and all its relative metabolites
Time frame: 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: * Total curcuminoids * Total parent compounds * Total sulfate metabolites * Total glucuronide metabolites * Total parent compounds and their relative sulfate and glucuronide metabolites * Curcumin and its relative sulfate and glucuronide metabolites * DMC and its relative sulfate and glucuronide metabolites * BDMC and its relative sulfate and glucuronide metabolites * Curcumin and all its relative metabolites
Time frame: 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: * Total curcuminoids * Total parent compounds * Total sulfate metabolites * Total glucuronide metabolites * Total parent compounds and their relative sulfate and glucuronide metabolites * Curcumin and its relative sulfate and glucuronide metabolites * DMC and its relative sulfate and glucuronide metabolites * BDMC and its relative sulfate and glucuronide metabolites * Curcumin and all its relative metabolites
Time frame: 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: * Total curcuminoids * Total parent compounds * Total sulfate metabolites * Total glucuronide metabolites * Total parent compounds and their relative sulfate and glucuronide metabolites * Curcumin and its relative sulfate and glucuronide metabolites * DMC and its relative sulfate and glucuronide metabolites * BDMC and its relative sulfate and glucuronide metabolites * Curcumin and all its relative metabolites
Time frame: 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: * Total curcuminoids * Total parent compounds * Total sulfate metabolites * Total glucuronide metabolites * Total parent compounds and their relative sulfate and glucuronide metabolites * Curcumin and its relative sulfate and glucuronide metabolites * DMC and its relative sulfate and glucuronide metabolites * BDMC and its relative sulfate and glucuronide metabolites * Curcumin and all its relative metabolites
Time frame: 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: * Total curcuminoids * Total parent compounds * Total sulfate metabolites * Total glucuronide metabolites * Total parent compounds and their relative sulfate and glucuronide metabolites * Curcumin and its relative sulfate and glucuronide metabolites * DMC and its relative sulfate and glucuronide metabolites * BDMC and its relative sulfate and glucuronide metabolites * Curcumin and all its relative metabolites
Time frame: 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: * Total curcuminoids * Total parent compounds * Total sulfate metabolites * Total glucuronide metabolites * Total parent compounds and their relative sulfate and glucuronide metabolites * Curcumin and its relative sulfate and glucuronide metabolites * DMC and its relative sulfate and glucuronide metabolites * BDMC and its relative sulfate and glucuronide metabolites * Curcumin and all its relative metabolites
Time frame: 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: * Total curcuminoids * Total parent compounds * Total sulfate metabolites * Total glucuronide metabolites * Total parent compounds and their relative sulfate and glucuronide metabolites * Curcumin and its relative sulfate and glucuronide metabolites * DMC and its relative sulfate and glucuronide metabolites * BDMC and its relative sulfate and glucuronide metabolites * Curcumin and all its relative metabolites
Time frame: 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: * Total curcuminoids * Total parent compounds * Total sulfate metabolites * Total glucuronide metabolites * Total parent compounds and their relative sulfate and glucuronide metabolites * Curcumin and its relative sulfate and glucuronide metabolites * DMC and its relative sulfate and glucuronide metabolites * BDMC and its relative sulfate and glucuronide metabolites * Curcumin and all its relative metabolites
Time frame: Data collected from 0 to 24 hours
Cmax of total curcuminoids, curcuminoid compounds and of their metabolites
Peak plasma concentration of: * Total curcuminoids * Total parent compounds * Total sulfate metabolites * Total glucuronide metabolites * Total parent compounds and their relative sulfate and glucuronide metabolites * Curcumin and its relative sulfate and glucuronide metabolites * DMC and its relative sulfate and glucuronide metabolites * BDMC and its relative sulfate and glucuronide metabolites * Curcumin and all its relative metabolites
Time frame: 0 to 24 hours
Dose-normalized Cmax of total curcuminoids, curcuminoid compounds and of their metabolites
Normalized (according curcuminoids ingested) peak plasma concentration of: * Total curcuminoids * Total parent compounds * Total sulfate metabolites * Total glucuronide metabolites * Total parent compounds and their relative sulfate and glucuronide metabolites * Curcumin and its relative sulfate and glucuronide metabolites * DMC and its relative sulfate and glucuronide metabolites * BDMC and its relative sulfate and glucuronide metabolites * Curcumin and all its relative metabolites
Time frame: 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: * Total curcuminoids * Total parent compounds * Total sulfate metabolites * Total glucuronide metabolites * Total parent compounds and their relative sulfate and glucuronide metabolites * Curcumin and its relative sulfate and glucuronide metabolites * DMC and its relative sulfate and glucuronide metabolites * BDMC and its relative sulfate and glucuronide metabolites * Curcumin and all its relative metabolites
Time frame: 0 to 24 hours
Tmax of total curcuminoids, curcuminoid compounds and of their metabolites
Time to peak plasma concentration of: * Total curcuminoids * Total parent compounds * Total sulfate metabolites * Total glucuronide metabolites * Total parent compounds and their relative sulfate and glucuronide metabolites * Curcumin and its relative sulfate and glucuronide metabolites * DMC and its relative sulfate and glucuronide metabolites * BDMC and its relative sulfate and glucuronide metabolites * Curcumin and all its relative metabolites
Time frame: 0 to 24 hours

Study locations

1 site

Biofortis
Saint-Herblain, 44800, France

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06300021
Lead sponsor: Givaudan France Naturals
Collaborators: BioFortis
Responsible party: Sponsor
First posted: Mar 8, 2024
Start date: Sep 14, 2021
Primary completion: May 20, 2022
Completion: May 20, 2022
Last update: Mar 8, 2024

Study contacts

Isabelle Metreau, MD

principal investigator · BioFortis

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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