Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of North Texas Health Science Center | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Juice Plus+ | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Juice Plus+ | Dietary Supplement | Participants will receive encapsulated fruit and vegetable juice concentrates or a placebo for a 24-month period |
|
| 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. |
| 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 |
Not provided
Inclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raheem Paxton, PhD | Contact | 205-348-6857 | rpaxton@ua.edu |
| Name | Affiliation | Role |
|---|---|---|
| Raheem Paxton, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, North East Medical Building | Recruiting | Tuscaloosa | Alabama | 35487 | United States |
Individual data will not be shared with other researchers
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
Not provided
Not provided
Participants will be randomized to experimental or placebo controlled condition
Not provided
Not provided
Both the investigator and the participants will be blinded to study conditions
| 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 |
| University of Alabama | Recruiting | Tuscaloosa | Alabama | 35487 | United States |
|
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |