Juice Plus Supplement Clinical Trial
Primary Purpose
Cognitive Impairment, Alzheimer Disease, Early Onset, Mild Cognitive Impairment
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Juice Plus+
Sponsored by
About this trial
This is an interventional prevention trial for Cognitive Impairment focused on measuring Fruits and Vegetables, Inflammation, Cognition
Eligibility 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
Sites / Locations
- University of Alabama, North East Medical BuildingRecruiting
- University of AlabamaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Juice Plus+
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Interleukin -5
Interleukin -5 pg/mL
Change in serum Amyloid A
Serum Amyloid A pg/mL
Change in Interleukin 6
Interleukin 6 pg/mL
Change in C-reactive protein
C-reactive protein pg/mL
Secondary Outcome Measures
Auditory Very Learning Test
Computer automated verbal memory recognition task
Stroop Test
Verbal interference
Trial Making task
Information processing speed
Full Information
NCT ID
NCT04656860
First Posted
April 3, 2020
Last Updated
April 5, 2021
Sponsor
University of Alabama, Tuscaloosa
Collaborators
University of North Texas Health Science Center
1. Study Identification
Unique Protocol Identification Number
NCT04656860
Brief Title
Juice Plus Supplement Clinical Trial
Official Title
Encapsulated Fruit and Vegetable Juice Concentrates, Cognition, and Inflammation - A Randomized Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 12, 2020 (Actual)
Primary Completion Date
March 12, 2022 (Anticipated)
Study Completion Date
March 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama, Tuscaloosa
Collaborators
University of North Texas Health Science Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Alzheimer Disease, Early Onset, Mild Cognitive Impairment
Keywords
Fruits and Vegetables, Inflammation, Cognition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to experimental or placebo controlled condition
Masking
ParticipantInvestigator
Masking Description
Both the investigator and the participants will be blinded to study conditions
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Juice Plus+
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Juice Plus+
Intervention Description
Participants will receive encapsulated fruit and vegetable juice concentrates or a placebo for a 24-month period
Primary Outcome Measure Information:
Title
Change in Interleukin -5
Description
Interleukin -5 pg/mL
Time Frame
Baseline, Year, 1, and Year 2.
Title
Change in serum Amyloid A
Description
Serum Amyloid A pg/mL
Time Frame
Baseline, Year, 1, and Year 2.
Title
Change in Interleukin 6
Description
Interleukin 6 pg/mL
Time Frame
Baseline, Year, 1, and Year 2.
Title
Change in C-reactive protein
Description
C-reactive protein pg/mL
Time Frame
Baseline, Year, 1, and Year 2.
Secondary Outcome Measure Information:
Title
Auditory Very Learning Test
Description
Computer automated verbal memory recognition task
Time Frame
Baseline, 6-months, 12-months, 18-months, and 24-months
Title
Stroop Test
Description
Verbal interference
Time Frame
Baseline, 6-months, 12-months, 18-months, and 24-months
Title
Trial Making task
Description
Information processing speed
Time Frame
Baseline, 6-months, 12-months, 18-months, and 24-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raheem Paxton, PhD
Phone
205-348-6857
Email
rpaxton@ua.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raheem Paxton, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama, North East Medical Building
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35487
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raheem Paxton, PhD
Phone
205-348-6857
Email
rpaxton@ua.edu
Facility Name
University of Alabama
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35487
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raheem Paxton, PhD
Phone
205-348-6857
Email
rpaxton@ua.edu
First Name & Middle Initial & Last Name & Degree
Raheem Paxton, PhD
Phone
204-348-6857
Email
rpaxton@ua.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual data will not be shared with other researchers
Learn more about this trial
Juice Plus Supplement Clinical Trial
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