Blackmores Memory (ARCLI II): Investigating the safety and efficacy of a Blackmores micronutrient formula on cognitive function in healthy adults aged 50-75 years.
- Conditions
- Cognitive functionMoodCardiovascular functionBrain functionMental Health - Studies of normal psychology, cognitive function and behaviourCardiovascular - Normal development and function of the cardiovascular systemNeurological - Studies of the normal brain and nervous systemAlternative and Complementary Medicine - Other alternative and complementary medicine
- Registration Number
- ACTRN12619000112167
- Lead Sponsor
- Blackmores Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Memory composite score, calculated from the memory tasks included in the CogTrack cognitive testing battery.[3 months post first dose]
- Secondary Outcome Measures
Name Time Method