Reducing the Effects of Aging on Cognition With Therapeutic Intervention of an Oral Nutrient (REACTION): A Pilot Trial
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|ClinicalTrials.gov Identifier: NCT04147624|
Recruitment Status : Completed
First Posted : November 1, 2019
Last Update Posted : January 25, 2023
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.
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Decline||Drug: Souvenaid Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||REACTION Trial: Medical Nutrition in Cognitive Aging, a Double-blind Controlled 6-month Study|
|Actual Study Start Date :||June 4, 2021|
|Actual Primary Completion Date :||December 2, 2022|
|Actual Study Completion Date :||December 2, 2022|
Experimental: Treatment Group
Participants in the treatment group will receive 125 mL of Souvenaid taken by mouth, once daily, for 6 consecutive months.
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.
Placebo Comparator: Placebo Group
Participants in the treatment group will receive 125 mL of iso-caloric placebo taken by mouth, once daily, for 6 consecutive months.
The Placebo used in this study is an oral beverage vitamin mixture containing Vitamins A, B1, B2, B3 and B5.
- Successful recruitment rate [ Time Frame: Baseline ]50% or more of those who fulfill the criteria and are invited to participate
- Successful recruitment time [ Time Frame: Baseline ]<110% of planned time
- Successful adherence to the intervention [ Time Frame: 6 months ]80% or more of the test product is consumed
- Successful Retention rate [ Time Frame: 6 months ]
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)
- Overall feasibility of this study will be assessed [ Time Frame: 6 months ]Will take into account all feasibility parameters
- Rey Auditory Verbal Learning Task (RAVLT) or WHO/UCLA Auditory Verbal Learning Task (AVLT) [ Time Frame: Baseline, 6 months ]The test takes 10-15 minutes plus a 30-minute delay during which time other measures can be done.
- Digit Span (WAIS-IV) [ Time Frame: Baseline, 6 months ]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.
- The Oral Trail Making Test B [ Time Frame: Baseline, 6 months ](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.
- Matrix reasoning from the Test My Brain (TMB) research battery [ Time Frame: Baseline, 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04147624
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Christian Camargo, MD||University of Miami|