NCT04656860

Juice Plus Supplement Clinical Trial

Encapsulated Fruit and Vegetable Juice Concentrates, Cognition, and Inflammation - A Randomized Placebo-controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Alabama, Tuscaloosa · Academic / Other
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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 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.

Conditions

• Cognitive Impairment
• Alzheimer Disease, Early Onset
• Mild Cognitive Impairment

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Juice Plus+	Participants will receive encapsulated fruit and vegetable juice concentrates or a placebo for a 24-month period

Timeline

• Start date: 2020-03-12
• Primary completion: 2022-03-12
• Completion: 2023-03-12
• First posted: 2020-12-07
• Last updated: 2021-04-08

Locations

2 sites across 1 country: United States