ACTRN12618001841268招募中4 期
The effects of 3-months supplementation with Ubiquinol (CoQ10) on cognition and mood in healthy adults aged over 60.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 128
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
- 60 Years 至 o limit（—）
- 性别
- All
入选标准
- •Participants who meet the following inclusion criteria will be included in the trial;
- •1.Non-smoking males and females aged 60 years and over
- •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
- •6.Must have normal or corrected to normal vision
- •7.No recent history (past five years) of chronic severe illness (longer than six weeks)
- •8.Participant is willing to maintain habitual diet (including caffeine and alcohol) and physical activity patterns throughout the study period.
- •9.Participant is willing and able to comfortably abstain from caffeine for 10 hours prior to and throughout the test visits, (up to 3 hours).
- •10.Participant is willing to abstain from alcohol for 24 hours and vigorous physical activity for 12 hours prior to all study visits.
- •11.Participant is willing and able to provide 2 blood samples
- •12.Score of 19 or above on the Memory Complaint Questionnaire (MAC-Q)
- •13.Not currently participating in any other clinical trial
- •14.Has access to an internet device capable of online testing
- •15.For inclusion in the 6MWT test only – In the opinion of the Research Nurse, at low risk of an adverse event occurring during physical activity/exercise (based on responses to the Adult Pre-exercise Screening Tool).
排除标准
- •Participants who report any of the following will be excluded from the trial;
- •1.Current smoker
- •2.Psychiatric disorder requiring treatment in the previous two years. Treatment includes prescription of antidepressant, antipsychotic or other long term medication and/or referral for long term psychotherapy. It does not include brief interventions for normal life events such as exam anxiety or bereavement.
- •3.Neurological conditions including epilepsy, Parkinson’s disease, Huntington’s Chorea and Myasthenia Gravis.
- •4.History of dementia, stroke and other neurological conditions.
- •5.Head trauma with loss of consciousness in the previous 6 months.
- •6.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).
- •7.Cardiovascular disease
- •8.Current endocrine, gastrointestinal or bleeding disorders.
- •9.Uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure > 90 mm Hg)
- •10.If female, pregnant or lactating.
- •11.Alcohol or drug abuse past or present
- •12.Other disorders affecting food metabolism, such as food allergies or intolerances
- •13.Recent history (past 5 years) of chronic/severe illness (longer than 6 weeks)
- •14.Taking the following (and not willing to abstain for the duration of the trial):
- •i.Coenzyme Q10 , ezetimibe therapy, vitamin E, multivitamins, B vitamin complex, ginkgo biloba, fish oil, St John’s Wort, antioxidants or other cognitive enhancing dietary or herbal supplement in the 4 weeks preceding the baseline study visit
- •ii.Anti-coagulant drugs (warfarin, heparin, clopidogrel, aspirin, dipyrimidole, apixiban, rivaroxiban, dabigatran, tirofiban, ticagrelor);
- •iii.anti-cholinergics or acetylcholinesterase inhibitors (bethanechol (Urecholine), donepezil (Aricept), rivastigmine (Exelon), galantamine (Reminyl), edrophonium (Enoln, Reversol, Tensilon), neostigmine (Prostigmin) pyridostigmine (Mestinon)
- •iv.anti-depressant medications
- •v.anti-anxiety medication such as diazepam (Valium), alprazolam (Xanax) or any other antianxiety medication including benzodiazepines
- •vi.Hypnotics including benzodiazepines, zolpidem and zopiclone
- •vii.Illicit drugs
- •viii.Antipsychotic drugs
- •15.A score below 19 on the MAC-Q
- •16.Vision that is not corrected to normal
- •17.Current regular alcohol use exceeding 14 standard drinks per week for women and 28 standard drinks per week for men
- •18.Current moderate or severe alcohol misuse disorder as defined in DSM5.
- •19.Current substance misuse disorder as defined in DSM5 (including misuse of prescription drugs)
- •20.Currently participating in or has participated in any other study involving an investigational product in the last 4 weeks.
- •21.Participant under administrative or legal supervision.
- •22.Allergy to the investigational product or formulation.
- •23.For exclusion from the 6MWT test only – In the opinion of the Research Nurse, at high risk of an adverse event occurring during physical activity/exercise (based on responses to the Adult Pre-exercise Screening Tool).
研究者
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