NCT03698318已完成不适用
Pharmacokinetics Study Assessing Bioavailability of Gingerols and Shogaols After Consumption of Five Ginger Extracts in Healthy Volunteers.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- AUC of total gingeroids plasmatic concentration
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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,
- •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.
结局指标
主要结局
AUC of total gingeroids plasmatic concentration
时间窗: 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.
次要结局
- AUC0-24H of each total gingeroids plasmatic concentrations(From 0 to 24 hours)
- AUC0-∞ of total gingeroids plasmatic concentrations(From 0 to infinity)
- Time to peak of each analytes of ginger plasmatic concentration(24 hours)
- Half-life time of each analytes of ginger plasmatic concentration separately(24 hours)
- 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)
- Half-life time of total gingeroids plasmatic concentrations(24 hours)
- Terminal elimination rate constant of total gingeroids plasmatic concentrations(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)
- Terminal elimination rate constant of each analytes of ginger plasmatic concentration separately(24 hours)
- Peak of total gingeroids plasmatic concentrations(24 hours)
- Time to peak of total gingeroids plasmatic concentrations(24 hours)
- Peak of each analytes of ginger plasmatic concentration(24 hours)
研究者
研究点 (2)
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