The purpose of this research is to assess the feasibility (e.g., recruitment rate, adherence rate and retention rate) of a clinical trial using virtual assessments to investigate the effect of a 6-month administration of a specific multi-nutrient oral supplement on cognitive aging. The study will also test whether a 6-month daily intake of a specific multinutrient can delay or reverse the effects of normal cognitive aging on other cognition domains as well as quality of life as measured by virtual assessments.
Participants with cognitive aging who meet the eligibility criteria are provided study information and scheduled for a screening visit via virtual encounter. At the screening visit, participants meeting criteria are enrolled, and a baseline visit is scheduled (same day, or separately.) The participants are then randomized to either the test product (specific multi-nutrient) or placebo. Study parameters will be assessed at baseline, and 6 months via a virtual online platform. Patients will be contacted monthly via telephone to promote compliance and monitor progress. An optional sample of blood may be provided by the participant if willing to participated in this optional sub-study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
67
Souvenaid is an oral beverage that contains a vitamin mixture (Vitamin A, B1, B2, B3, B5, D) plus three main active ingredients: omega-3 fatty acids, uridine monophosphate, and choline.
The Placebo used in this study is an oral beverage vitamin mixture containing Vitamins A, B1, B2, B3 and B5.
University of Miami
Miami, Florida, United States
Successful recruitment rate
50% or more of those who fulfill the criteria and are invited to participate
Time frame: Baseline
Successful recruitment time
\<110% of planned time
Time frame: Baseline
Successful adherence to the intervention
80% or more of the test product is consumed
Time frame: 6 months
Successful Retention rate
Less than 30% of the participants drop-out; Tracking the percentage of participants in the "Per-Protocol" population (i.e., no protocol deviation) less than 30% of the participants drop-out Tracking the percentage of participants in the "Per-Protocol" population (i.e., no protocol deviation)
Time frame: 6 months
Overall feasibility of this study will be assessed
Will take into account all feasibility parameters
Time frame: 6 months
Rey Auditory Verbal Learning Task (RAVLT) or WHO/UCLA Auditory Verbal Learning Task (AVLT)
The test takes 10-15 minutes plus a 30-minute delay during which time other measures can be done.
Time frame: Baseline, 6 months
Digit Span (WAIS-IV)
measures attention and working memory using exercises that require participants to recite a A series of progressively longer sequence of numbers in forwards, backwards and sequencing order.
Time frame: Baseline, 6 months
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The Oral Trail Making Test B
(TMT-B) assesses working memory and cognitive flexibility. Participants are asked to verbally alternate between letters and numbers in sequential order as quickly as possible.
Time frame: Baseline, 6 months
Matrix reasoning from the Test My Brain (TMB) research battery
The task provides a measure of fluid intelligence and non-verbal reasoning. It is based on a well-validated and widely used matrix reasoning tasks but adapted for virtual administration.
Time frame: Baseline, 6 months