A double-blind study to evaluate the effectiveness of bioavailability enhancers to increase blood absorption of antioxidants and fat-soluble nutrients over a 48-hour period in otherwise healthy individuals.

RDC Global Pty Ltd0 个研究点目标入组 610 人开始时间: 2019年7月8日最近更新: 2022年8月15日

试验速览

暂无简介。

•Men and women aged over 18 years with normal dietary habits (no medically prescribed diet or slimming diet) including good representation of age and gender specifics.
•- Clinically healthy, BMI 18.5-39.9
•- No history or evidence of clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled.
•- Participant’s full agreement and ability to consent to participation in the study
•- Participant’s ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points.
•- Female participants must be on a form of prescribed birth control (e.g. oral contraceptive pill)

•- Allergy to the investigational material
•- Previous history of hematologic diseases (e.g. known susceptibility to thrombosis)
•- Concomitant use of anticoagulant drugs (e.g. Warfarin Sodium) and any other prescribed medication (not for control of previously mentioned conditions above) expect for females on the oral contraceptive pill
•- Female participants currently pregnant, lactating or undergoing fertility treatment
•- Regular use of supplements containing the investigational material (e.g. omega-3 fatty acids), in the last 3 months, regular consumption of foods containing the investigational material (e.g. fish for omega-3, red meat and eggs for CoQ10)
•- High alcohol consumption (equal to 21 standard drinks/week)
•- Reported participation in another trial 1 month before the start of the study
•- Recent history (within 12 months) of substance abuse including alcohol
•- Development of serious, adverse events/reactions including but not limited to; fainting, life-threating dehydration and/or serious bruising from blood sampling, excessive and prolonged diarrhoea or gastrointestinal upset from fish oil consumption.
•- Received treatment (radio &/or chemotherapy) for cancer (excluding BCC skin cancer) in past 2 years.
•- Current smoker.

发起方