Juice Plus Supplement Clinical Trial

• ClinicalTrials.gov Identifier: NCT04656860
• Recruitment Status: Unknown
• First Posted: December 7, 2020
• Last Update Posted: April 8, 2021
• Sponsor: University of Alabama, Tuscaloosa
• Collaborator: University of North Texas Health Science Center
• Information provided by (Responsible Party): University of Alabama, Tuscaloosa

Tracking Information

• First Submitted Date: April 3, 2020
• First Posted Date: December 7, 2020
• Last Update Posted Date: April 8, 2021
• Actual Study Start Date: March 12, 2020
• Estimated Primary Completion Date: March 12, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 5, 2021)

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

Original Primary Outcome Measures (submitted: December 4, 2020)

• Change in Interleukin (IL)-5 [ Time Frame: Baseline, Year, 1, and Year 2. ]
  Interleukin (IL)-5 pg/mL
• Change in serum Amyloid A [ Time Frame: Baseline, Year, 1, and Year 2. ]
  Serum Amyloid A pg/mL
• Change in Interleukin 6 [ Time Frame: Baseline, Year, 1, and Year 2. ]
  Interleukin 6 pg/mL
• Change in C-reactive protein (CRP) [ Time Frame: Baseline, Year, 1, and Year 2. ]
  C-reactive protein pg/mL

Current Secondary Outcome Measures (submitted: April 5, 2021)

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

Original Secondary Outcome Measures (submitted: December 4, 2020)

• Auditory Very Learning Test [ Time Frame: Baseline, 6-months, 12-months, 18-months, and 24-months ]
  Computer automated verbal memory recognition task
• Supplement adherence [ Time Frame: Baseline, 6-months, 12-months, 18-months, and 24-months ]
  Adherence to supplement intake
• Stroop Test [ Time Frame: Baseline, 6-months, 12-months, 18-months, and 24-months ]
  Verbal interference
• Trial Making task [ Time Frame: Baseline, 6-months, 12-months, 18-months, and 24-months ]
  Information processing speed

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Juice Plus Supplement Clinical Trial
• Official Title: Encapsulated Fruit and Vegetable Juice Concentrates, Cognition, and Inflammation - A Randomized Placebo-controlled Trial
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Cognitive Impairment
• Alzheimer Disease, Early Onset
• Mild Cognitive Impairment

Intervention

Dietary Supplement: Juice Plus+

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

Study 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.
  Intervention: Dietary Supplement: Juice Plus+
• 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.
  Intervention: Dietary Supplement: Juice Plus+

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 4, 2020): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 12, 2023
• Estimated Primary Completion Date: March 12, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 55 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04656860
• Other Study ID Numbers: 17-19-490
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Individual data will not be shared with other researchers

• Current Responsible Party: University of Alabama, Tuscaloosa
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Alabama, Tuscaloosa
• Original Study Sponsor: Same as current
• Collaborators: University of North Texas Health Science Center

Investigators

• Principal Investigator: Raheem Paxton, PhD; University of Alabama at Birmingham

• PRS Account: University of Alabama, Tuscaloosa
• Verification Date: June 2020