Juice Plus Supplement Clinical Trial

Last updated: April 5, 2021
Sponsor: University of Alabama, Tuscaloosa
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Alzheimer's Disease

Memory Loss

Treatment

N/A

Clinical Study ID

NCT04656860
17-19-490
  • Ages 55-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Study Design

Total Participants: 150
Study Start date:
March 12, 2020
Estimated Completion Date:
March 12, 2023

Study 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.

Connect with a study center

  • University of Alabama

    Tuscaloosa, Alabama 35487
    United States

    Active - Recruiting

  • University of Alabama, North East Medical Building

    Tuscaloosa, Alabama 35487
    United States

    Active - Recruiting

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