Clinical trial NCT04656860: Juice Plus Supplement Clinical Trial
Official title: Encapsulated Fruit and Vegetable Juice Concentrates, Cognition, and Inflammation - A Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Impairment
Alzheimer Disease, Early Onset
Mild Cognitive Impairment
Keywords: Fruits and Vegetables
Inflammation
Cognition
Lead sponsor: University of Alabama, Tuscaloosa
Sponsor class: OTHER
Collaborators: name: University of North Texas Health Science Center
First posted: 2020-12-07
Enrollment: 150
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to experimental or placebo controlled condition
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* • Men and women ≥55 years old will be eligible participants

Exclusion Criteria:

* Prior neurological or psychiatric condition
* Using medications or supplements that influence cognition or inflammation (e.g., nootropics, asprin, and Nonsteroidal anti-inflammatory drugs,),
* Prior cancer diagnosis,
* Major respiratory, kidney, liver, and gastrointestinal issues
* Currently enrolled in a weight loss program or taking an appetite suppressant;
* Current smokers or excessive alcohol users
* Consume \>= 4 servings of fruits and vegetables per day

  * Participate in \>= 90 minutes of purposeful physical activity per week
  * Do not have a mobile phone
  * Do not have a data plan or regular wireless network

Primary outcomes:
measure: Change in Interleukin -5
timeFrame: Baseline, Year, 1, and Year 2.
measure: Change in serum Amyloid A
timeFrame: Baseline, Year, 1, and Year 2.
measure: Change in Interleukin 6
timeFrame: Baseline, Year, 1, and Year 2.
measure: Change in C-reactive protein
timeFrame: Baseline, Year, 1, and Year 2.
Secondary outcomes:
measure: Auditory Very Learning Test
timeFrame: Baseline, 6-months, 12-months, 18-months, and 24-months
measure: Stroop Test
timeFrame: Baseline, 6-months, 12-months, 18-months, and 24-months
measure: Trial Making task
timeFrame: Baseline, 6-months, 12-months, 18-months, and 24-months
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: University of Alabama, North East Medical Building
state: Alabama
city: Tuscaloosa
country: United States
facility: University of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Raheem Paxton, PhD
role: PRINCIPAL_INVESTIGATOR
References: