Juice Plus Supplement Clinical Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Dietary Supplement: Juice Plus+
Participants will receive encapsulated fruit and vegetable juice concentrates or a placebo for a 24-month period
|
| 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. |
Dietary Supplement: Juice Plus+
Participants will receive encapsulated fruit and vegetable juice concentrates or a placebo for a 24-month period
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Auditory Very Learning Test [Baseline, 6-months, 12-months, 18-months, and 24-months]
Computer automated verbal memory recognition task
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama, North East Medical Building | Tuscaloosa | Alabama | United States | 35487 |
| 2 | University of Alabama | Tuscaloosa | Alabama | United States | 35487 |
Sponsors and Collaborators
- University of Alabama, Tuscaloosa
- University of North Texas Health Science Center
Investigators
- Principal Investigator: Raheem Paxton, PhD, University of Alabama at Birmingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17-19-490