ACTRN12619000112167招募中3 期
Investigating the safety and efficacy of acute and chronic administration of Blackmores’ ARCLI proprietary formula on cognitive function and mood in healthy adults
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 75 Years（—）
- 性别
- All
入选标准
- •People who meet the following inclusion criteria will be included in the trial:
- •1.Male or female, aged 50-75 years, inclusive.
- •2.Willing and able to provide written informed consent.
- •3.Understands and is willing and able to comply with all study procedures.
- •4.Fluent in written and spoken English.
- •5.Participants must be in general good health defined for the purposes of this study by the absence of the exclusion criteria and as judged by the Investigator/Clinical advisor on the basis of medical history.
- •6.Normal, or corrected to normal vision.
- •7.Participant has internet access in the home and has basic computer skills in order to complete the questionnaires and tasks online.
- •8.Willing to maintain habitual diet (including caffeine and alcohol) and physical activity patterns throughout the study period.
- •9.Willing to abstain from caffeine for 10 hours prior to and throughout the test visits, (up to 6 hours).
- •10.Willing to abstain from alcohol for 24 hours and vigorous physical activity for 12 hours prior to all study visits.
排除标准
- •People who meet the following exclusion criteria will not be included in the trial:
- •1.Current smoker
- •2.History of Type I diabetes (insulin dependent) or Type II diabetes on treatment. (Type II diabetes and prediabetes treated with diet alone is not an exclusion).
- •3.Cardiovascular disease.
- •4.Neurological conditions including epilepsy, Parkinson’s disease, Myaesthenia Gravis, Huntington’s Chorea.
- •5.History of dementia, stroke or other neurological conditions.
- •6.Head trauma with loss of consciousness in the previous 6 months.
- •7.History of anxiety, depression, or psychiatric disorders requiring treatment in the last 2 years.
- •8.Current endocrine, gastrointestinal or bleeding disorders.
- •9.Current moderate or severe alcohol misuse disorder as defined in DSM5.
- •10.Current substance misuse disorder as defined in DSM5 (including misuse of prescription drugs)
- •11.Uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure > 100 mm Hg)
- •12.If female, pregnant or lactating.
- •13.Not willing to abstain from using vitamin E, multivitamins, B vitamin complex, ginkgo biloba, fish oil, St John’s Wort, or other cognitive enhancing dietary or herbal supplements over the study period.
- •14.Taking the following (in the 4 weeks preceding the baseline visit and for study duration):
- •i.Vitamin supplements including multivitamins, B vitamin complex, vitamin E
- •ii.Herbal supplements including ginkgo biloba, fish oil, St John’s Wort or other cognitive enhancing dietary or herbal supplement.
- •iii.Anti-coagulant drugs (warfarin, heparin, clopidogrel, aspirin, dipyrimidole, apixiban , rivaroxiban, dabigatran, tirofiban , ticagrelor);
- •iv.anti-cholinergics or acetylcholinesterase inhibitors (bethanechol (Urecholine), donepezil (Aricept), rivastigmine (Exelon), galantamine (Reminyl), pyridostigmine (Mestinon)
- •v.anti-depressant medications
- •vi.anti-anxiety medication including benzodiazepines
- •vii.Hypnotics including benzodiazepines, zolpidem and zopiclone
- •15.Allergy to the investigational product or any of the ingredients.
- •16.Participation in any other study involving an investigational product in the preceding 4 weeks.
- •For imaging participants ONLY:
- •17. Left-handed.
- •18.Metal implants such as metal joints, pacemakers, or stents.
- •19.Claustrophobic
研究者
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