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Encapsulated Fruit and Vegetable Juice Concentrates, Cognition, and Inflammation - A Randomized Placebo-controlled Trial
The study is designed to determine whether encapsulated fruit and vegetable juice concentrates can improve biological indicators of cognitive and multiple dimensions of memory and learning.
Preventive interventions that delay the onset of mild cognitive impairment and benign forgetfulness have the potential to delay or even prevent the onset of Alzheimer's disease. However, few studies have examined the feasibility of Encapsulated Fruit and Vegetable Juice Concentrates in robust clinical trials; this limitation prevents investigators from determining the real value of these supplements. Therefore, we propose to enroll 150 adults aged 55 and older to a 24-month randomized placebo-controlled trial. Participants enrolled in the experimental condition will be encouraged to consume 6 Encapsulated Fruit and Vegetable Juice Concentrates capsules per day and 33 grams of a soy-based beverage power per day, which included 5 grams of fiber. Participants enrolled in the controlled condition will receive six placebo capsules and encouraged to maintain an adequate diet. Primary outcomes will include objective measures of cognition, and a panel of inflammatory markers, peptides, enzymes, and other biological markers known to be associated with cognitive decline.
Age
55 - 90 years
Sex
ALL
Healthy Volunteers
Yes
University of Alabama, North East Medical Building
Tuscaloosa, Alabama, United States
University of Alabama
Tuscaloosa, Alabama, United States
Start Date
March 12, 2020
Primary Completion Date
March 12, 2022
Completion Date
March 12, 2023
Last Updated
April 8, 2021
150
ESTIMATED participants
Juice Plus+
DIETARY_SUPPLEMENT
Lead Sponsor
University of Alabama, Tuscaloosa
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04123314