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Juice Plus Supplement Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04656860
Recruitment Status : Unknown
Verified June 2020 by University of Alabama, Tuscaloosa.
Recruitment status was:  Recruiting
First Posted : December 7, 2020
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
University of North Texas Health Science Center
Information provided by (Responsible Party):
University of Alabama, Tuscaloosa

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Alzheimer Disease, Early Onset Mild Cognitive Impairment Dietary Supplement: Juice Plus+ Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to experimental or placebo controlled condition
Masking: Double (Participant, Investigator)
Masking Description: Both the investigator and the participants will be blinded to study conditions
Primary Purpose: Prevention
Official Title: Encapsulated Fruit and Vegetable Juice Concentrates, Cognition, and Inflammation - A Randomized Placebo-controlled Trial
Actual Study Start Date : March 12, 2020
Estimated Primary Completion Date : March 12, 2022
Estimated Study Completion Date : March 12, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Dietary Supplement: Juice Plus+
Participants will receive encapsulated fruit and vegetable juice concentrates or a placebo for a 24-month period
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.
 Dietary Supplement: Juice Plus+
Participants will receive encapsulated fruit and vegetable juice concentrates or a placebo for a 24-month period


Outcome Measures
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Primary Outcome Measures :
  1. Change in Interleukin -5 [ Time Frame: Baseline, Year, 1, and Year 2. ]
    Interleukin -5 pg/mL

  2. Change in serum Amyloid A [ Time Frame: Baseline, Year, 1, and Year 2. ]
    Serum Amyloid A pg/mL

  3. Change in Interleukin 6 [ Time Frame: Baseline, Year, 1, and Year 2. ]
    Interleukin 6 pg/mL

  4. Change in C-reactive protein [ Time Frame: Baseline, Year, 1, and Year 2. ]
    C-reactive protein pg/mL


Secondary Outcome Measures :
  1. Auditory Very Learning Test [ Time Frame: Baseline, 6-months, 12-months, 18-months, and 24-months ]
    Computer automated verbal memory recognition task

  2. Stroop Test [ Time Frame: Baseline, 6-months, 12-months, 18-months, and 24-months ]
    Verbal interference

  3. Trial Making task [ Time Frame: Baseline, 6-months, 12-months, 18-months, and 24-months ]
    Information processing speed


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04656860


Contacts
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Contact: Raheem Paxton, PhD 205-348-6857 rpaxton@ua.edu

Locations
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United States, Alabama
University of Alabama, North East Medical Building Recruiting
Tuscaloosa, Alabama, United States, 35487
Contact: Raheem Paxton, PhD    205-348-6857    rpaxton@ua.edu   
University of Alabama Recruiting
Tuscaloosa, Alabama, United States, 35487
Contact: Raheem Paxton, PhD    205-348-6857    rpaxton@ua.edu   
Contact: Raheem Paxton, PhD    204-348-6857    rpaxton@ua.edu   
Sponsors and Collaborators
University of Alabama, Tuscaloosa
University of North Texas Health Science Center
Investigators
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Principal Investigator: Raheem Paxton, PhD University of Alabama at Birmingham
More Information
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Responsible Party: University of Alabama, Tuscaloosa
ClinicalTrials.gov Identifier: NCT04656860    
Other Study ID Numbers: 17-19-490
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual data will not be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alabama, Tuscaloosa:
Fruits and Vegetables
Inflammation
Cognition
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders