Pharmacokinetics Assessing Bioavailability of Gingerols and Shogaols of Five Ginger Extracts
KING
Pharmacokinetics Study Assessing Bioavailability of Gingerols and Shogaols After Consumption of Five Ginger Extracts in Healthy Volunteers.
1 other identifier
interventional
20
1 country
1
Brief 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. These five extracts have the same quantity of active substance but with different titration (1.6%, 5%, 39%, 26% and 26% NOP80).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedStudy Start
First participant enrolled
October 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2018
CompletedJanuary 11, 2021
January 1, 2021
2 months
October 4, 2018
January 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From 0 to 8 hours
Secondary Outcomes (14)
AUC0-8H of total gingeroids plasmatic concentration
From 0 to 8 hours
AUC0-8H of each analytes of ginger plasmatic concentration separately
From 0 to 8 hours
AUC0-24H of each total gingeroids plasmatic concentrations
From 0 to 24 hours
AUC0-24H of each analytes of ginger plasmatic concentration separately
From 0 to 24 hours
AUC0-∞ of each analytes of ginger plasmatic concentration separately
From 0 to infinity
- +9 more secondary outcomes
Study Arms (10)
Subject sequence 1
EXPERIMENTALSubject 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
EXPERIMENTALSubject 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
EXPERIMENTALSubject 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
EXPERIMENTALSubject 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
EXPERIMENTALSubject 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
EXPERIMENTALSubject 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
EXPERIMENTALSubject 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
EXPERIMENTALSubject 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
EXPERIMENTALSubject 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
EXPERIMENTALSubject 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).
Interventions
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)
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)
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)
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)
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)
Eligibility Criteria
You may qualify if:
- 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,
- 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.
You may not qualify if:
- 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,
- 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,
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Givaudan France Naturalslead
- Biofortis Mérieux NutriSciencescollaborator
Study Sites (1)
Biofortis Mérieux Nutrisciences
Saint-Herblain, 44800, France
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Romain Le Cozannet, PhD
Givaudan France Naturals
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2018
First Posted
October 9, 2018
Study Start
October 15, 2018
Primary Completion
December 7, 2018
Study Completion
December 7, 2018
Last Updated
January 11, 2021
Record last verified: 2021-01