RecruitingPhase 3ACTRN12619000112167

Blackmores Memory (ARCLI II): Investigating the safety and efficacy of a Blackmores micronutrient formula on cognitive function in healthy adults aged 50-75 years.

Investigating the safety and efficacy of acute and chronic administration of Blackmores’ ARCLI proprietary formula on cognitive function and mood in healthy adults


Sponsor

Blackmores Ltd

Enrollment

120 participants

Start Date

Jun 11, 2019

Study Type

Interventional

Conditions

Summary

The current study will sample healthy older volunteers aged 50-75 years to examine the effects of the Blackmores micronutrient formulation on cognitive function, mood, cardiovascular function and brain function. Research has investigated the individual components of the combination formula but research is yet to examine the effects of this newly devised combination formula on cognitive, cardiovascular and biochemical outcomes. One hundred and twenty participants will be recruited to take part in this trial, to allow for a complete set of 100 participants after attrition. Participants will complete three visits at the site (screening, baseline and 90 days follow-up), as well as three testing sessions completed online in their own home (14 days, 30 days and 60 days post first dose). Forty participants (20 per treatment arm) will also undergo brain imaging procedures at the baseline and follow-up visits. We hypothesize that significant improvement in cognition will occur after 3 months administration of the combination formula relative to placebo. In addition, it is hypothesized that the largest cognitive improvements will be seen at the longest time points (3 months) of administration. Secondary or exploratory outcomes/hypotheses concern the effect of this supplement on the neuroimaging, biochemical and neuropsychological variables.


Eligibility

Sex: Both males and femalesMin Age: 50 YearssMax Age: 75 Yearss

Inclusion Criteria4

  • Male or female, aged 50-75 years, inclusive.
  • Willing and able to provide written informed consent.
  • Understands and is willing and able to comply with all study procedures.
  • Fluent in written and spoken English.

Exclusion Criteria32

  • Normal, or corrected to normal vision.
  • Participant has internet access in the home and has basic computer skills in order to complete the questionnaires and tasks online.
  • Willing to maintain habitual diet (including caffeine and alcohol) and physical activity patterns throughout the study period.
  • Willing to abstain from caffeine for 10 hours prior to and throughout the test visits, (up to 6 hours).
  • Willing to abstain from alcohol for 24 hours and vigorous physical activity for 12 hours prior to all study visits.
  • Current smoker
  • 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).
  • Cardiovascular disease.
  • Neurological conditions including epilepsy, Parkinson’s disease, Myaesthenia Gravis, Huntington’s Chorea.
  • History of dementia, stroke or other neurological conditions.
  • Head trauma with loss of consciousness in the previous 6 months.
  • History of anxiety, depression, or psychiatric disorders requiring treatment in the last 2 years.
  • Current endocrine, gastrointestinal or bleeding disorders.
  • Current moderate or severe alcohol misuse disorder as defined in DSM5.
  • Current substance misuse disorder as defined in DSM5 (including misuse of prescription drugs)
  • Uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure > 100 mm Hg)
  • If female, pregnant or lactating.
  • 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.
  • 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
  • Allergy to the investigational product or any of the ingredients.
  • Participation in any other study involving an investigational product in the preceding 4 weeks.
  • For imaging participants ONLY:
  • Left-handed.
  • Metal implants such as metal joints, pacemakers, or stents.
  • Claustrophobic

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Interventions

Blackmores' Micronutrient formulation: The excipient ingredients of the active formulation have been kept private at the request of the sponsor. The micronutrient formulation contains 12.5mg Pyr

Blackmores' Micronutrient formulation: The excipient ingredients of the active formulation have been kept private at the request of the sponsor. The micronutrient formulation contains 12.5mg Pyridoxine Hydrochloride, 200mcg Folic Acid, 150mg r, s-alpha lipoic acid, 250mcg Cyanocobalamin, and 41.6mg Soy Lecithin (equivalent to 25mg Phosphatyldiserine. Participants will be asked to consume 1 capsule, twice daily with food (Total of 2 capsules per day, one in the morning and one in the evening), for 90 days in their own home. Participants will also be supplied with an additional 14 days' supply of capsules in case the final visit is delayed. Participants will be provided with a diary/log that they will be instructed to tick when they have taken their treatment each day. In addition, they will be required to return any left over treatment at their final visit so that compliance can be calculated based on capsule count. A sub-group of 40 participants will undergo MRI assessment to investigate changes in brain function. Randomisation will be stratified such that 20 participants per treatment arm will undergo this procedure. Participants will be allocated to this sub-group based on their interest in taking part in the additional procedures and additional inclusion/exclusion criteria such as having no metal implants.


Locations(1)

VIC, Australia

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ACTRN12619000112167


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