Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Alzheimer Disease, Early Onset
  • Cognitive Impairment
  • Mild Cognitive Impairment
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will be randomized to experimental or placebo controlled conditionMasking: Double (Participant, Investigator)Masking Description: Both the investigator and the participants will be blinded to study conditionsPrimary Purpose: Prevention

Participation Requirements

Age
Between 55 years and 90 years
Gender
Both males and females

Description

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 clinic...

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.

Tracking Information

NCT #
NCT04656860
Collaborators
University of North Texas Health Science Center
Investigators
Principal Investigator: Raheem Paxton, PhD University of Alabama at Birmingham