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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
150
Participants will receive encapsulated fruit and vegetable juice concentrates or a placebo for a 24-month period
University of Alabama, North East Medical Building
Tuscaloosa, Alabama, United States
RECRUITINGUniversity of Alabama
Tuscaloosa, Alabama, United States
RECRUITINGChange in Interleukin -5
Interleukin -5 pg/mL
Time frame: Baseline, Year, 1, and Year 2.
Change in serum Amyloid A
Serum Amyloid A pg/mL
Time frame: Baseline, Year, 1, and Year 2.
Change in Interleukin 6
Interleukin 6 pg/mL
Time frame: Baseline, Year, 1, and Year 2.
Change in C-reactive protein
C-reactive protein pg/mL
Time frame: Baseline, Year, 1, and Year 2.
Auditory Very Learning Test
Computer automated verbal memory recognition task
Time frame: Baseline, 6-months, 12-months, 18-months, and 24-months
Stroop Test
Verbal interference
Time frame: Baseline, 6-months, 12-months, 18-months, and 24-months
Trial Making task
Information processing speed
Time frame: Baseline, 6-months, 12-months, 18-months, and 24-months
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