Juice Plus Supplement Clinical Trial

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Dietary Supplement: Juice Plus+


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to experimental or placebo controlled condition
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Juice Plus+<br>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+<br>* Participants will receive encapsulated fruit and vegetable juice concentrates or a placebo for a 24-month period<br>|
| Placebo Comparator: Placebo<br>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+<br>* Participants will receive encapsulated fruit and vegetable juice concentrates or a placebo for a 24-month period<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fruits and Vegetables, Inflammation, Cognition