Alzheimer Disease, Early Onset, Cognitive Impairment, Mild Cognitive Impairment
Conditions
Keywords
Fruits and Vegetables, Inflammation, Cognition
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.
Interventions
DIETARY_SUPPLEMENTJuice Plus+
Participants will receive encapsulated fruit and vegetable juice concentrates or a placebo for a 24-month period
Sponsors
University of North Texas Health Science Center
University of Alabama, Tuscaloosa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Both the investigator and the participants will be blinded to study conditions
Intervention model description
Participants will be randomized to experimental or placebo controlled condition
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Interleukin -5 | Baseline, Year, 1, and Year 2. | Interleukin -5 pg/mL |
| Change in serum Amyloid A | Baseline, Year, 1, and Year 2. | Serum Amyloid A pg/mL |
| Change in Interleukin 6 | Baseline, Year, 1, and Year 2. | Interleukin 6 pg/mL |
| Change in C-reactive protein | Baseline, Year, 1, and Year 2. | C-reactive protein pg/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroop Test | Baseline, 6-months, 12-months, 18-months, and 24-months | Verbal interference |
| Trial Making task | Baseline, 6-months, 12-months, 18-months, and 24-months | Information processing speed |
| Auditory Very Learning Test | Baseline, 6-months, 12-months, 18-months, and 24-months | Computer automated verbal memory recognition task |
Countries
United States
Contacts
Primary ContactRaheem Paxton, PhD
Outcome results
None listed