Juice Plus Supplement Clinical Trial

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Mild Cognitive Impairment; Alzheimer Disease, Early Onset
• Intervention / Treatment: Dietary supplement: Juice Plus+

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35487
      • Recruiting
      • University of Alabama
      • Contact: Raheem Paxton, PhD; Phone Number: 204-348-6857; Email: rpaxton@ua.edu
    • Tuscaloosa, Alabama, United States, 35487
      • Recruiting
      • University of Alabama, North East Medical Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Interleukin -5	Interleukin -5 pg/mL	Baseline, Year, 1, and Year 2.
Change in serum Amyloid A	Serum Amyloid A pg/mL	Baseline, Year, 1, and Year 2.
Change in Interleukin 6	Interleukin 6 pg/mL	Baseline, Year, 1, and Year 2.
Change in C-reactive protein	C-reactive protein pg/mL	Baseline, Year, 1, and Year 2.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Auditory Very Learning Test	Computer automated verbal memory recognition task	Baseline, 6-months, 12-months, 18-months, and 24-months
Stroop Test	Verbal interference	Baseline, 6-months, 12-months, 18-months, and 24-months
Trial Making task	Information processing speed	Baseline, 6-months, 12-months, 18-months, and 24-months

Collaborators and Investigators

• Sponsor: University of Alabama, Tuscaloosa
• Collaborators: University of North Texas Health Science Center

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2020
• Primary Completion (Anticipated): March 12, 2022
• Study Completion (Anticipated): March 12, 2023

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Inflammation; Cognition; Fruits and Vegetables
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: 17-19-490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual data will not be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No