Healthy SubjectKINGNCT03698318
Pharmacokinetics Assessing Bioavailability of Gingerols and Shogaols of Five Ginger Extracts
A study testing Tested product n°1, Tested product n°2 and Tested product n°3 in people with Healthy Subject, run by Givaudan France Naturals at 1 site in France.
Trial summary
The objective of this study is to assess bioavailability of total gingeroids, free gingerols and shogaols, so as their glucuronide and sulfate metabolites, in the plasma, after consumption of a single dose of 5 different ginger extracts. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- Tested product n°1, Tested product n°2 and Tested product n°3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2018to 7 Dec 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 55 years (limits included),
- BMI between 18.5 and 25 kg/m² (limits included),
- Weight stable within +/- 5% in the last 3 months,
- 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),
- Agreeing not to consume food, drink and condiment containing ginger during the all duration of the study,
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- Good general and mental health with in the opinion of the investigator: non 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 chornic 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),
- Current disease states that are contraindicated to sujects with dietary supplementation: chronic diarrhea, constipation or abdominal pain, Inflammatory bowel diseases (Crohn's disease or ulcerative colitis), Cirrhosis...,
- Suffering from Irritable Bowel Syndrome (IBS) diagnosed by a medical doctor and treated with chronic medication,
- Suffering from an uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg),
- 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,
- Pregnant or lactating women or intending to become pregnant within 3 months ahead,
- On any chronic drug treatment (for example 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,
- Under treatment and/or dietary supplement and/or "health food" which could significantly affect parameters followed during the study according to the investigator (i.e. antibiotics, laxatives, antidiarrheal therapy, containg plant extracts (including ginger extracts), probiotics, prebiotics, symbiotics, vitamins and minerals) or stopped less than 3 months before the V0 visit,
- Regular consumption of food and/or drink and/or condiment containing ginger (gari, pickled ginger, Japanese food, tea or infusion...) defined as at least 3 times per week,
- 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,
- With a current or planned in the next 3 months specific diet (hyper or hypocaloric, vegan, vegetarian...) or stopped less than 3 months before the study,
- 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,
- Control record (Glycaemia, GGT, ASAT, ALAT, Urea, Creatinine and Comple Blood Count) with clinically significant abnormality according to the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics Study Assessing Bioavailability of Gingerols and Shogaols After Consumption of Five Ginger Extracts in Healthy Volunteers.
The objective of this study is to assess bioavailability of total gingeroids, free gingerols and shogaols, so as their glucuronide and sulfate metabolites, in the plasma, after consumption of a single dose of 5 different ginger extracts. These five extracts have the same quantity of active substance but with different titration (1.6%, 5%, 39%, 26% and 26% NOP80).
- Conditions
- Healthy Subject
- Being tested
- Tested product n°1, Tested product n°2, Tested product n°3, Tested product n°4, Tested product n°5
- Keywords
- Ginger, Pharmacokinetics, Shogaols, Gingerols, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tested product n°1Dietary supplement
Also called Gingest TM 26% 28.9 mg
1 capsule (26% of gingerol/shogaol in 100 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic)
Tested product n°2Dietary supplement
Also called Oleoresin 39% 28.9 mg
1 capsule (38.6% of gingerol/shogaol in 74.9 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic)
Tested product n°3Dietary supplement
Also called Ginger 5% 28.9 mg
2 capsules (6.8% of gingerol/shogaol in 424.3 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic)
Tested product n°4Dietary supplement
Also called Gingest TM 26% NOP80 28.9 mg
1 capsule (27% of gingerol/shogaol in 104.9 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic)
Tested product n°5Dietary supplement
Also called Ginger 1.6% 28.9 mg
6 capsules (1.6% of gingerol/shogaol in 1806.25 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic)
| Study group | Role | What they receive |
|---|---|---|
| Subject sequence 1 | Experimental | Subject allocation sequence 1. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). Receives: Dietary Supplement: Tested product n°1; Dietary Supplement: Tested product n°2; Dietary Supplement: Tested product n°3; Dietary Supplement: Tested product n°4; Dietary Supplement: Tested product n°5 |
| Subject sequence 2 | Experimental | Subject allocation sequence 2. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). Receives: Dietary Supplement: Tested product n°1; Dietary Supplement: Tested product n°2; Dietary Supplement: Tested product n°3; Dietary Supplement: Tested product n°4; Dietary Supplement: Tested product n°5 |
| Subject sequence 3 | Experimental | Subject allocation sequence 3. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). Receives: Dietary Supplement: Tested product n°1; Dietary Supplement: Tested product n°2; Dietary Supplement: Tested product n°3; Dietary Supplement: Tested product n°4; Dietary Supplement: Tested product n°5 |
| Subject sequence 4 | Experimental | Subject allocation sequence 4. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). Receives: Dietary Supplement: Tested product n°1; Dietary Supplement: Tested product n°2; Dietary Supplement: Tested product n°3; Dietary Supplement: Tested product n°4; Dietary Supplement: Tested product n°5 |
| Subject sequence 5 | Experimental | Subject allocation sequence 5. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). Receives: Dietary Supplement: Tested product n°1; Dietary Supplement: Tested product n°2; Dietary Supplement: Tested product n°3; Dietary Supplement: Tested product n°4; Dietary Supplement: Tested product n°5 |
| Subject sequence 6 | Experimental | Subject allocation sequence 6. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). Receives: Dietary Supplement: Tested product n°1; Dietary Supplement: Tested product n°2; Dietary Supplement: Tested product n°3; Dietary Supplement: Tested product n°4; Dietary Supplement: Tested product n°5 |
| Subject sequence 7 | Experimental | Subject allocation sequence 7. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). Receives: Dietary Supplement: Tested product n°1; Dietary Supplement: Tested product n°2; Dietary Supplement: Tested product n°3; Dietary Supplement: Tested product n°4; Dietary Supplement: Tested product n°5 |
| Subject sequence 8 | Experimental | Subject allocation sequence 8. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). Receives: Dietary Supplement: Tested product n°1; Dietary Supplement: Tested product n°2; Dietary Supplement: Tested product n°3; Dietary Supplement: Tested product n°4; Dietary Supplement: Tested product n°5 |
| Subject sequence 9 | Experimental | Subject allocation sequence 9. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). Receives: Dietary Supplement: Tested product n°1; Dietary Supplement: Tested product n°2; Dietary Supplement: Tested product n°3; Dietary Supplement: Tested product n°4; Dietary Supplement: Tested product n°5 |
| Subject sequence 10 | Experimental | Subject allocation sequence 10. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). Receives: Dietary Supplement: Tested product n°1; Dietary Supplement: Tested product n°2; Dietary Supplement: Tested product n°3; Dietary Supplement: Tested product n°4; Dietary Supplement: Tested product n°5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of total gingeroids plasmatic concentration
The primary endpoint is the AUC (Area Under the Curve) of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentration from 0 to 8 hours (AUC0-8h) following consumption of ginger extract (expressed in µg.h/mL) and considering the following time-points: T0 to T480. The primary comparisons are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg and Gingest TM 26% versus Ginger 1.6% 28.9 mg.
Measured: From 0 to 8 hours
Secondary outcomes (14)
AUC0-8H of total gingeroids plasmatic concentration
AUC of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations from 0 to 8 hours following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T480.
Secondary comparisons are GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg
Measured: From 0 to 8 hours
AUC0-8H of each analytes of ginger plasmatic concentration separately
AUC of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10-gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations from 0 to 8 hours following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T480.
Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg
Measured: From 0 to 8 hours
AUC0-24H of each total gingeroids plasmatic concentrations
AUC of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations from 0 to 24 hours following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T24H.
Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg
Measured: From 0 to 24 hours
AUC0-24H of each analytes of ginger plasmatic concentration separately
AUC of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10-gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations from 0 to 24 hours following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T24H.
Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg
Measured: From 0 to 24 hours
AUC0-∞ of each analytes of ginger plasmatic concentration separately
AUC of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10-gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations from 0 to infinity following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T24H.
Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg
Measured: From 0 to infinity
AUC0-∞ of total gingeroids plasmatic concentrations
AUC of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations from 0 to infinity following consumption of each test product (expressed in µg.h/mL) and considering the following time-points : T0 to T24H.
Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg
Measured: From 0 to infinity
Half-life time of total gingeroids plasmatic concentrations
Half-life time of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations following consumption of each test product (expressed in minutes).
Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg
Measured: 24 hours
Half-life time of each analytes of ginger plasmatic concentration separately
Half-life time of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10- gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate plasmatic concentrations following consumption of each test product (expressed in minutes).
Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg
Measured: 24 hours
Terminal elimination rate constant of each analytes of ginger plasmatic concentration separately
Terminal elimination rate constant of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10- gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations following consumption of each test product.
Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg
Measured: 24 hours
Terminal elimination rate constant of total gingeroids plasmatic concentrations
Terminal elimination rate constant of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations following consumption of each test product.
Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg
Measured: 24 hours
Time to peak of total gingeroids plasmatic concentrations
Time to peak of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations following consumption of each test product (expressed in minutes).
Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg
Measured: 24 hours
Time to peak of each analytes of ginger plasmatic concentration
Time to peak of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10-gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations following consumption of each test product (expressed in minutes).
Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg
Measured: 24 hours
Peak of each analytes of ginger plasmatic concentration
Peak of the analytes (6-, 8-, 10-gingerols; 6-, 8-, 10-gingerols glucuronide; 6-, 8-, 10-gingerols sulfate; 6-, 8-, 10-shogaols; 6-, 8-, 10-shogaols glucuronide and 6-, 8-, 10-shogaols sulfate) plasmatic concentrations following consumption of each test product (expressed in µg/mL).
Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg
Measured: 24 hours
Peak of total gingeroids plasmatic concentrations
Peak of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentrations following consumption of each test product (expressed in µg/mL).
Comparisons of interest are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Oleoresin 39% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 1.6% 28.9 mg, GingestTM 26% NOP80 28.9 mg versus Ginger 5% 28.9 mg, Gingest TM 26% 28.9 mg versus GingestTM 26% NOP80 28.9 mg, Ginger 5% 28.9 mg versus Oleoresin 39% 28.9 mg, Ginger 5% 28.9 mg versus Ginger 1.6% 28.9 mg and Oleoresin 39% 28.9 mg versus Ginger 1.6% 28.9 mg
Measured: 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 Oct 2018
- Study start15 Oct 2018
- Primary completion7 Dec 2018
- Study completion7 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Givaudan France Naturals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences
- Responsible party
- Sponsor
- Investigators
- Romain Le Cozannet, PhD, Study director, Givaudan France Naturals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698318
- Sponsor's protocol ID
- 2017-A03645-48
- Acronym
- KING
- Status last verified
- Jan 2021
- First submitted
- 4 Oct 2018
- Last updated
- 11 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics Study Assessing Bioavailability of Gingerols and Shogaols After Consumption of Five Ginger Extracts in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT03698318
- Acronym / sponsor ID
- KING / 2017-A03645-48
- Conditions
- Healthy Subject
- Keywords
- Ginger, Pharmacokinetics, Shogaols, Gingerols, Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Givaudan France NaturalsIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 7 Dec 2018 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 9 Oct 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 objective of this study is to assess bioavailability of total gingeroids, free gingerols and shogaols, so as their glucuronide and sulfate metabolites, in the plasma, after consumption of a single dose of 5 different ginger extracts. These five extracts have the same quantity of active substance but with different titration (1.6%, 5%, 39%, 26% and 26% NOP80).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Subject sequence 1 | Experimental | Dietary Supplement: Tested product n°1, Dietary Supplement: Tested product n°2, Dietary Supplement: Tested product n°3, Dietary Supplement: Tested product n°4, Dietary Supplement: Tested product n°5Subject allocation sequence 1. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
| Subject sequence 2 | Experimental | Dietary Supplement: Tested product n°1, Dietary Supplement: Tested product n°2, Dietary Supplement: Tested product n°3, Dietary Supplement: Tested product n°4, Dietary Supplement: Tested product n°5Subject allocation sequence 2. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
| Subject sequence 3 | Experimental | Dietary Supplement: Tested product n°1, Dietary Supplement: Tested product n°2, Dietary Supplement: Tested product n°3, Dietary Supplement: Tested product n°4, Dietary Supplement: Tested product n°5Subject allocation sequence 3. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
| Subject sequence 4 | Experimental | Dietary Supplement: Tested product n°1, Dietary Supplement: Tested product n°2, Dietary Supplement: Tested product n°3, Dietary Supplement: Tested product n°4, Dietary Supplement: Tested product n°5Subject allocation sequence 4. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
| Subject sequence 5 | Experimental | Dietary Supplement: Tested product n°1, Dietary Supplement: Tested product n°2, Dietary Supplement: Tested product n°3, Dietary Supplement: Tested product n°4, Dietary Supplement: Tested product n°5Subject allocation sequence 5. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
| Subject sequence 6 | Experimental | Dietary Supplement: Tested product n°1, Dietary Supplement: Tested product n°2, Dietary Supplement: Tested product n°3, Dietary Supplement: Tested product n°4, Dietary Supplement: Tested product n°5Subject allocation sequence 6. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
| Subject sequence 7 | Experimental | Dietary Supplement: Tested product n°1, Dietary Supplement: Tested product n°2, Dietary Supplement: Tested product n°3, Dietary Supplement: Tested product n°4, Dietary Supplement: Tested product n°5Subject allocation sequence 7. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
| Subject sequence 8 | Experimental | Dietary Supplement: Tested product n°1, Dietary Supplement: Tested product n°2, Dietary Supplement: Tested product n°3, Dietary Supplement: Tested product n°4, Dietary Supplement: Tested product n°5Subject allocation sequence 8. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
| Subject sequence 9 | Experimental | Dietary Supplement: Tested product n°1, Dietary Supplement: Tested product n°2, Dietary Supplement: Tested product n°3, Dietary Supplement: Tested product n°4, Dietary Supplement: Tested product n°5Subject allocation sequence 9. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
| Subject sequence 10 | Experimental | Dietary Supplement: Tested product n°1, Dietary Supplement: Tested product n°2, Dietary Supplement: Tested product n°3, Dietary Supplement: Tested product n°4, Dietary Supplement: Tested product n°5Subject allocation sequence 10. Intervention : the subject will receive the five products (tested product n°1, tested product n°2, tested product n°3, tested product n°4 and tested product n°5) in a certain order of assignment of each study product (which will be randomly attributed to him via the randomization sequence). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age between 18 and 55 years (limits included),
- BMI between 18.5 and 25 kg/m² (limits included),
- Weight stable within +/- 5% in the last 3 months,
- 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),
Key exclusion criteria (25 listed)
- Suffering from a metabolic or endocrine disorder such as diabetes, uncontrolled or controlled thyroidal trouble or other metabolic disorder,
- Suffering from a severe chornic 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),
- Current disease states that are contraindicated to sujects with dietary supplementation: chronic diarrhea, constipation or abdominal pain, Inflammatory bowel diseases (Crohn's disease or ulcerative colitis), Cirrhosis...,
- Suffering from Irritable Bowel Syndrome (IBS) diagnosed by a medical doctor and treated with chronic medication,
- Suffering from an uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg),
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 |
|---|---|---|
| Tested product n°1Also: Gingest TM 26% 28.9 mg1 capsule (26% of gingerol/shogaol in 100 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic) | 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 |
| Tested product n°2Also: Oleoresin 39% 28.9 mg1 capsule (38.6% of gingerol/shogaol in 74.9 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic) | 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 |
| Tested product n°3Also: Ginger 5% 28.9 mg2 capsules (6.8% of gingerol/shogaol in 424.3 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic) | 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 |
| Tested product n°4Also: Gingest TM 26% NOP80 28.9 mg1 capsule (27% of gingerol/shogaol in 104.9 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic) | 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 |
| Tested product n°5Also: Ginger 1.6% 28.9 mg6 capsules (1.6% of gingerol/shogaol in 1806.25 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic) | 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
AUC of total gingeroids plasmatic concentration
Time frame: From 0 to 8 hours
The primary endpoint is the AUC (Area Under the Curve) of total gingeroids (gingerols, shogaols and their metabolites) plasmatic concentration from 0 to 8 hours (AUC0-8h) following consumption of ginger extract (expressed in µg.h/mL) and considering the following time-points: T0 to T480. The primary comparisons are GingestTM 26% 28.9 mg versus Oleroresin 39% 28.9 mg, Gingest TM 26% 28.9 mg versus Ginger 5% 28.9 mg and Gingest TM 26% versus Ginger 1.6% 28.9 mg.
14 secondary outcomes
AUC0-8H of total gingeroids plasmatic concentration
Time frame: From 0 to 8 hours
AUC0-8H of each analytes of ginger plasmatic concentration separately
Time frame: From 0 to 8 hours
AUC0-24H of each total gingeroids plasmatic concentrations
Time frame: From 0 to 24 hours
AUC0-24H of each analytes of ginger plasmatic concentration separately
Time frame: From 0 to 24 hours
AUC0-∞ of each analytes of ginger plasmatic concentration separately
Time frame: From 0 to infinity
AUC0-∞ of total gingeroids plasmatic concentrations
Time frame: From 0 to infinity
Half-life time of total gingeroids plasmatic concentrations
Time frame: 24 hours
Half-life time of each analytes of ginger plasmatic concentration separately
Time frame: 24 hours
Terminal elimination rate constant of each analytes of ginger plasmatic concentration separately
Time frame: 24 hours
Terminal elimination rate constant of total gingeroids plasmatic concentrations
Time frame: 24 hours
Time to peak of total gingeroids plasmatic concentrations
Time frame: 24 hours
Time to peak of each analytes of ginger plasmatic concentration
Time frame: 24 hours
Peak of each analytes of ginger plasmatic concentration
Time frame: 24 hours
Peak of total gingeroids plasmatic concentrations
Time frame: 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 11 Jan 2021.
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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.
Romain Le Cozannet, PhD study director
Givaudan France Naturals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tested product n°1, Tested product n°2 and Tested product n°3 in people with Healthy Subject, 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 25 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 11 Jan 2021. 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?
AUC of total gingeroids plasmatic concentration (time frame: From 0 to 8 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 11 Jan 2021.