Juice Plus Supplement Clinical Trial

NCT04656860 | Unknown

• 1 other identifier: 17-19-490
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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

Keywords

Fruits and Vegetables; Inflammation; Cognition

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Auditory Very Learning Test

  Baseline, 6-months, 12-months, 18-months, and 24-months

• Stroop Test

  Baseline, 6-months, 12-months, 18-months, and 24-months

• Trial Making task

  Baseline, 6-months, 12-months, 18-months, and 24-months

Study Arms (2)

Juice Plus+

EXPERIMENTAL

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+

Placebo

PLACEBO COMPARATOR

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+

Interventions

Juice Plus+ DIETARY_SUPPLEMENT

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

Juice Plus+; Placebo

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead
• University of North Texas Health Science Center: collaborator

Study Sites (2)

University of Alabama, North East Medical Building

Tuscaloosa, Alabama, 35487, United States

RECRUITING

University of Alabama

Tuscaloosa, Alabama, 35487, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Inflammation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raheem Paxton, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raheem Paxton, PhD

CONTACT

205-348-6857; rpaxton@ua.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both the investigator and the participants will be blinded to study conditions
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to experimental or placebo controlled condition

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: December 7, 2020
• Study Start: March 12, 2020
• Primary Completion: March 12, 2022
• Study Completion: March 12, 2023
• Last Updated: April 8, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)