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

Brain function Mood Cardiovascular function

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

Plain Language Summary

Simplified for easier understanding

As we get older, keeping our memory and thinking sharp becomes more important than ever. This study investigates whether a specific combination of micronutrients formulated by Blackmores — including B vitamins, antioxidants, and other compounds thought to support brain health — can improve cognitive function, mood, and brain activity in healthy adults aged 50 to 75. Participants take either the Blackmores supplement or a placebo for 90 days and complete thinking and memory tests at several points during the study, including online from home. A subset of 40 participants also undergo brain imaging (MRI). The study measures whether the supplement leads to improvements in attention, memory, and other cognitive skills compared to placebo. You may be eligible if you are aged 50 to 75, are in generally good health, have basic computer skills for online testing, and are willing to stop taking other vitamin or cognitive supplements during the study. You are not eligible if you smoke, have cardiovascular disease, neurological conditions (including dementia or stroke), recent head trauma, active psychiatric illness, uncontrolled high blood pressure, or are pregnant. You must also be willing to stop taking certain supplements like fish oil, B vitamins, vitamin E, and ginkgo biloba for the study period.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.