HealthyNCT06300021
Bioavailability of Curcuminoids From Turmipure Gold® in Different Food Matrices
A study testing TPG capsule, TPG ready to drink and TPG dairy analog in people with Healthy, run by Givaudan France Naturals at 1 site in France.
Trial 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… 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?
- TPG capsule, TPG ready to drink and TPG dairy analog
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2021to 20 May 2022
- 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 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
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- 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
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 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Cross-over Clinical Trial to Study the Bioavailability of Curcuminoids From Turmipure Gold® in Different Food Matrices
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
- Healthy
- Being tested
- TPG capsule, TPG ready to drink, TPG dairy analog, TPG probiotic drink, TPG gummies
- Keywords
- Turmeric, Curcuminoids, Curcumin, Bioavailability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPG capsuleDietary supplement
A dietary supplement product in capsule form containing 300 mg Turmipure Gold®
TPG ready to drinkDietary supplement
Ingredient stick containing 300 mg Turmipure Gold® mixed in 60 mL mango fruit nectar
TPG dairy analogDietary supplement
Ingredient stick containing 300 mg Turmipure Gold® mixed in 240 mL oat milk
TPG probiotic drinkDietary supplement
Ingredient stick containing 300 mg Turmipure Gold® mixed in a 100 mL probiotic yogurt drink base
TPG gummiesDietary supplement
Pectin gummies containing 300 mg Turmipure Gold®
TPG sport barDietary supplement
Sport nutrition bar containing 300 mg Turmipure Gold®
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
| 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 Receives: 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 |
| 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 Receives: 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 |
| 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 Receives: 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 |
| 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 Receives: 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 |
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 to 24 hours
Secondary outcomes (13)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 posted8 Mar 2024
- Study start14 Sep 2021
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Monocentric, randomized, cross-over, open-label, pharmacokinetic study
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Givaudan France Naturals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
- Investigators
- Isabelle Metreau, MD, Principal investigator, BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300021
- Sponsor's protocol ID
- PEC19242
- Other IDs
- 2021-A00317-34
- Status last verified
- Mar 2024
- First submitted
- 6 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Cross-over Clinical Trial to Study the Bioavailability of Curcuminoids From Turmipure Gold® in Different Food Matrices
- ClinicalTrials.gov ID
- NCT06300021
- Acronym / sponsor ID
- PEC19242
- Conditions
- Healthy
- Keywords
- Turmeric, Curcuminoids, Curcumin, Bioavailability, Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Givaudan France NaturalsIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 8 Mar 2024 (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 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).
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Monocentric, randomized, cross-over, open-label, pharmacokinetic study
| Arm | Type | Receives |
|---|---|---|
| Sequence capsule - ready to drink - sport bar - dairy analog - gummies - probiotic drink | Experimental | 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 barSubjects receive Turmipure Gold® preparations in different food matrices in the following order: capsule - ready to drink - sport bar - dairy analog - gummies - probiotic drink |
| Sequence dairy analog - probiotic drink - ready to drink - gummies - capsule - sport bar | Experimental | 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 barSubjects receive Turmipure Gold® preparations in different food matrices in the following order: dairy analog - probiotic drink - ready to drink - gummies - capsule - sport bar |
| Sequence gummies - sport bar - probiotic drink - capsule - dairy analog - ready to drink | Experimental | 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 barSubjects receive Turmipure Gold® preparations in different food matrices in the following order: gummies - sport bar - probiotic drink - capsule - dairy analog - ready to drink |
| Sequence probiotic drink - gummies - dairy analog - sport bar - ready to drink - capsule | Experimental | 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 barSubjects 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 | 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 barSubjects receive Turmipure Gold® preparations in different food matrices in the following order: ready to drink - dairy analog - capsule - probiotic drink - sport bar - gummies |
| Sequence sport bar - capsule - gummies - ready to drink - probiotic drink - dairy analog | Experimental | 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 barSubjects receive Turmipure Gold® preparations in different food matrices in the following order: sport bar - capsule - gummies - ready to drink - probiotic drink - dairy analog |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (26 listed)
- 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)
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 |
|---|---|---|
| TPG capsuleA dietary supplement product in capsule form containing 300 mg Turmipure Gold® | Dietary supplement | Sequence capsule - ready to drink - sport bar - dairy analog - gummies - probiotic drink, Sequence dairy analog - probiotic drink - ready to drink - gummies - capsule - sport bar, Sequence gummies - sport bar - probiotic drink - capsule - dairy analog - ready to drink, Sequence probiotic drink - gummies - dairy analog - sport bar - ready to drink - capsule, Sequence ready to drink - dairy analog - capsule - probiotic drink - sport bar - gummies, Sequence sport bar - capsule - gummies - ready to drink - probiotic drink - dairy analog |
| TPG ready to drinkIngredient stick containing 300 mg Turmipure Gold® mixed in 60 mL mango fruit nectar | Dietary supplement | Sequence capsule - ready to drink - sport bar - dairy analog - gummies - probiotic drink, Sequence dairy analog - probiotic drink - ready to drink - gummies - capsule - sport bar, Sequence gummies - sport bar - probiotic drink - capsule - dairy analog - ready to drink, Sequence probiotic drink - gummies - dairy analog - sport bar - ready to drink - capsule, Sequence ready to drink - dairy analog - capsule - probiotic drink - sport bar - gummies, Sequence sport bar - capsule - gummies - ready to drink - probiotic drink - dairy analog |
| TPG dairy analogIngredient stick containing 300 mg Turmipure Gold® mixed in 240 mL oat milk | Dietary supplement | Sequence capsule - ready to drink - sport bar - dairy analog - gummies - probiotic drink, Sequence dairy analog - probiotic drink - ready to drink - gummies - capsule - sport bar, Sequence gummies - sport bar - probiotic drink - capsule - dairy analog - ready to drink, Sequence probiotic drink - gummies - dairy analog - sport bar - ready to drink - capsule, Sequence ready to drink - dairy analog - capsule - probiotic drink - sport bar - gummies, Sequence sport bar - capsule - gummies - ready to drink - probiotic drink - dairy analog |
| TPG probiotic drinkIngredient stick containing 300 mg Turmipure Gold® mixed in a 100 mL probiotic yogurt drink base | Dietary supplement | Sequence capsule - ready to drink - sport bar - dairy analog - gummies - probiotic drink, Sequence dairy analog - probiotic drink - ready to drink - gummies - capsule - sport bar, Sequence gummies - sport bar - probiotic drink - capsule - dairy analog - ready to drink, Sequence probiotic drink - gummies - dairy analog - sport bar - ready to drink - capsule, Sequence ready to drink - dairy analog - capsule - probiotic drink - sport bar - gummies, Sequence sport bar - capsule - gummies - ready to drink - probiotic drink - dairy analog |
| TPG gummiesPectin gummies containing 300 mg Turmipure Gold® | Dietary supplement | Sequence capsule - ready to drink - sport bar - dairy analog - gummies - probiotic drink, Sequence dairy analog - probiotic drink - ready to drink - gummies - capsule - sport bar, Sequence gummies - sport bar - probiotic drink - capsule - dairy analog - ready to drink, Sequence probiotic drink - gummies - dairy analog - sport bar - ready to drink - capsule, Sequence ready to drink - dairy analog - capsule - probiotic drink - sport bar - gummies, Sequence sport bar - capsule - gummies - ready to drink - probiotic drink - dairy analog |
| TPG sport barSport nutrition bar containing 300 mg Turmipure Gold® | Dietary supplement | Sequence capsule - ready to drink - sport bar - dairy analog - gummies - probiotic drink, Sequence dairy analog - probiotic drink - ready to drink - gummies - capsule - sport bar, Sequence gummies - sport bar - probiotic drink - capsule - dairy analog - ready to drink, Sequence probiotic drink - gummies - dairy analog - sport bar - ready to drink - capsule, Sequence ready to drink - dairy analog - capsule - probiotic drink - sport bar - gummies, Sequence sport bar - capsule - gummies - ready to drink - probiotic drink - dairy analog |
Primary outcome
Dose-normalized AUC0-24h of total curcuminoids
Time frame: 0 to 24 hours
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
13 secondary outcomes
Dose-normalized AUC0-24h of curcuminoid compounds and of their metabolites
Time frame: 0 to 24 hours
Dose-normalized AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites
Time frame: 0 to 8 hours
Dose-normalized AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites
Time frame: Data collected from 0 to 24 hours
AUC0-24h of total curcuminoids, curcuminoid compounds and of their metabolites
Time frame: 0 to 24 hours
AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites
Time frame: 0 to 8 hours
AUC0-∞ of total curcuminoids, curcuminoid compounds and of their 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
Time frame: 0 to 24 hours
Relative bioavailability for normalized AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites
Time frame: 0 to 8 hours
Relative bioavailability for normalized AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites
Time frame: Data collected from 0 to 24 hours
Cmax of total curcuminoids, curcuminoid compounds and of their metabolites
Time frame: 0 to 24 hours
Dose-normalized Cmax of total curcuminoids, curcuminoid compounds and of their metabolites
Time frame: 0 to 24 hours
Half-life of total curcuminoids, curcuminoid compounds and of their metabolites
Time frame: 0 to 24 hours
Tmax of total curcuminoids, curcuminoid compounds and of their metabolites
Time frame: 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 8 Mar 2024.
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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.
Isabelle Metreau, MD principal investigator
BioFortis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TPG capsule, TPG ready to drink and TPG dairy analog 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 10 inclusion and 26 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 8 Mar 2024. 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 AUC0-24h of total curcuminoids (time frame: 0 to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.