Juice Plus Supplement Clinical Trial

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04656860
• Other study ID #: 17-19-490
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2020
• Est. completion date: March 12, 2023

Study information

• Verified date: June 2020
• Source: University of Alabama, Tuscaloosa
• Contact: Raheem Paxton, PhD
• Phone: 205-348-6857
• Email: rpaxton[@]ua.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 12, 2023
• Est. primary completion date: March 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	University of Alabama	Tuscaloosa	Alabama
United States	University of Alabama, North East Medical Building	Tuscaloosa	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama, Tuscaloosa	University of North Texas Health Science Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Interleukin -5	Interleukin -5 pg/mL	Baseline, Year, 1, and Year 2.
Primary	Change in serum Amyloid A	Serum Amyloid A pg/mL	Baseline, Year, 1, and Year 2.
Primary	Change in Interleukin 6	Interleukin 6 pg/mL	Baseline, Year, 1, and Year 2.
Primary	Change in C-reactive protein	C-reactive protein pg/mL	Baseline, Year, 1, and Year 2.
Secondary	Auditory Very Learning Test	Computer automated verbal memory recognition task	Baseline, 6-months, 12-months, 18-months, and 24-months
Secondary	Stroop Test	Verbal interference	Baseline, 6-months, 12-months, 18-months, and 24-months
Secondary	Trial Making task	Information processing speed	Baseline, 6-months, 12-months, 18-months, and 24-months