Recruiting

Juice Plus

Sponsor:

University of Alabama, Tuscaloosa

Code:

NCT04656860

Conditions

Cognitive Impairment

Alzheimer Disease, Early Onset

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

Interventions

Juice Plus+

Study Details

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.

Conditions

Cognitive Impairment

Alzheimer Disease, Early Onset

Mild Cognitive Impairment

Study ID

NCT04656860

Start date

Mar 12, 2020

Status verified date

Jun, 2020

Completion date

Mar 12, 2023

Anticipated

Primary completion date

Mar 12, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Juice Plus+

Participants will consume 6 capsules daily consisting of a combination of Juice Plus+ Garden Blend, Juice Plus+ Orchard Blend and Juice Plus+ Berry Blend. Participants will consume supplements for 24-months.

placebo comparator: Placebo

Participants will consume 6 capsules daily consisting of microcrystalline cellulose, rice starch, vegetarian capsule (cellulose), and magnesium stearate. Participants in this condition will receive 1-year of supplements after the study is completed.

Interventions

Juice Plus+

Participants will receive encapsulated fruit and vegetable juice concentrates or a placebo for a 24-month period

Primary outcome measure

  • Change in Interleukin -5 [ Time Frame: Baseline, Year, 1, and Year 2. ]
  • Change in serum Amyloid A [ Time Frame: Baseline, Year, 1, and Year 2. ]
  • Change in Interleukin 6 [ Time Frame: Baseline, Year, 1, and Year 2. ]
  • Change in C-reactive protein [ Time Frame: Baseline, Year, 1, and Year 2. ]

Central Contacts and Locations

Central contacts

Raheem Paxton, PhD

205-348-6857rpaxton@ua.edu

Locations

University of Alabama, North East Medical Building

Recruiting

Tuscaloosa, Alabama, United States, 35487

Contacts

Raheem Paxton, PhD

205-348-6857rpaxton@ua.edu

University of Alabama

Recruiting

Tuscaloosa, Alabama, United States, 35487

Contacts

Raheem Paxton, PhD

205-348-6857rpaxton@ua.edu

Raheem Paxton, PhD

204-348-6857rpaxton@ua.edu

More Information

Sponsor

University of Alabama, Tuscaloosa

Last update posted

Apr 8, 2021

Last verified

Jun, 2020

Keywords

  • Fruits and Vegetables
  • Inflammation
  • Cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama, Tuscaloosa on 2021-04-08.