Juice Plus Supplement Clinical Trial

University of Alabama, Tuscaloosa

Status: Unknown

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

Treatments: Dietary Supplement: Juice Plus+

Study type: Interventional

Funder types: Other

Identifiers

NCT04656860

17-19-490

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 55 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

Juice Plus+

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Juice Plus+

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Juice Plus+