ISRCTN89815519已完成未知
Bioavailability and physiological effects of dietary antioxidants of different functional foods and beverages in volunteers
ycotec Ltd0 个研究点目标入组 360 人开始时间: 2015年3月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 360
研究概览
简要总结
2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30319730 results 2019 Other publications in https://doi.org/10.1002/fsn3.799 Lycopene presence in facial skin corneocytes and sebum and its association with circulating lycopene isomer profile: Effects of age and dietary supplementation (added 25/04/2023) 2018 Other publications in https://doi.org/10.4103/ijabmr.ijabmr_367_17 Pharmacokinetics and Oxidation Parameters in Volunteers Supplemented with Microencapsulated Docosahexaenoic Acid (added 25/04/2023)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. All study participants should be healthy Caucasian males and females, age 20–80
- •2. Female subjects of childbearing potential should agree to undergo pregnancy tests and to use an appropriate method of contraception (i.e. oral contraceptive steroids, intrauterine device, barrier method)
- •3. All study participants should have findings within the normal range in medical history, physical examination, and relevant laboratory tests
- •4. All study participants should agree to undergo a pre-study physical examination and laboratory investigations
- •5. All study participants should be able to comprehend and willing to sign both statements of informed consent (for screening and phase-related procedures)
- •6. Only non-smokers or mild to moderate smokers (less than 10 cigarettes per day) should be enrolled in the study
排除标准
- •The exclusion criteria (subjects who meet any of the following criteria are to be excluded from participating in the study):
- •1. The presence of a psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements
- •2. History of or current compulsive alcohol abuse (> 10 drinks weekly), or regular exposure to other substances of abuse
- •3. Participation in another study with an experimental drug within 4 weeks before the initiation of the proposed dietary study
- •4. A major illness within 3 months before commencement of the screening period
- •5. History of hypersensitivity to food ingredients
- •6. History of bronchial asthma
- •7. Donation or loss of blood equal to or exceeding 500 ml during the 8 weeks before the initiation of the proposed dietary study or donation or loss blood from 250 to 500 ml in the 6 weeks before the initiation of the proposed dietary study or donation or loss of blood up to 250 ml in the 4 weeks before the initiation of the proposed dietary study
- •8. Resting heart rate of over 100 beats per minute or below 45 beats per minute during the screening period, either supine or standing
- •9. Positive testing for HIV or hepatitis B antigens
- •10. History of epilepsy
- •11. Difficulty fasting or consuming the standard meals
- •12. Subjects who do not tolerate venipuncture
- •13. Subjects on a special diet (e. g. liquid, protein, raw food diet) within 4 weeks before the initiation of the proposed dietary study
- •14. Drug addiction requiring treatment in the past 12 months
- •15. Subjects who do not agree to fully participate in wash-out period and exclude from the diet the recommended food for 4 weeks before the initiation of the study and during the study
研究者
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