Cognitive ImpairmentNCT04656860
Juice Plus Supplement Clinical Trial
A study testing Juice Plus+ in people with Cognitive Impairment and Alzheimer Disease, Early Onset, run by University of Alabama, Tuscaloosa at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Alzheimer Disease, Early Onset, Mild Cognitive Impairment
- What is being tested?
- Juice Plus+
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Mar 2020to 12 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Men and women ≥55 years old will be eligible participants
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Alabama, North East Medical Building
Tuscaloosa, Alabama, 35487
Raheem Paxton, PhD, 205-348-6857, rpaxton@ua.edu
- Recruiting
University of Alabama
Tuscaloosa, Alabama, 35487
Raheem Paxton, PhD, 205-348-6857, rpaxton@ua.edu
Raheem Paxton, PhD, 204-348-6857, rpaxton@ua.edu
About this study
Official title: Encapsulated Fruit and Vegetable Juice Concentrates, Cognition, and Inflammation - A Randomized Placebo-controlled Trial
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.
Read the 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.
- Being tested
- Juice Plus+
- Keywords
- Fruits and Vegetables, Inflammation, Cognition
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juice Plus+Dietary supplement
Participants will receive encapsulated fruit and vegetable juice concentrates or a placebo for a 24-month period
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Juice Plus+ |
| 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. Receives: Dietary Supplement: Juice Plus+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Interleukin -5
Interleukin -5 pg/mL
Measured: Baseline, Year, 1, and Year 2.
Change in serum Amyloid A
Serum Amyloid A pg/mL
Measured: Baseline, Year, 1, and Year 2.
Change in Interleukin 6
Interleukin 6 pg/mL
Measured: Baseline, Year, 1, and Year 2.
Change in C-reactive protein
C-reactive protein pg/mL
Measured: Baseline, Year, 1, and Year 2.
Secondary outcomes (3)
Auditory Very Learning Test
Computer automated verbal memory recognition task
Measured: Baseline, 6-months, 12-months, 18-months, and 24-months
Stroop Test
Verbal interference
Measured: Baseline, 6-months, 12-months, 18-months, and 24-months
Trial Making task
Information processing speed
Measured: Baseline, 6-months, 12-months, 18-months, and 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start12 Mar 2020
- Primary completion12 Mar 2022 (estimated)
- Study completion12 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to experimental or placebo controlled condition
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Texas Health Science Center
- Responsible party
- Sponsor
- Investigators
- Raheem Paxton, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656860
- Sponsor's protocol ID
- 17-19-490
- Status last verified
- Jun 2020
- First submitted
- 3 Apr 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encapsulated Fruit and Vegetable Juice Concentrates, Cognition, and Inflammation - A Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04656860
- Acronym / sponsor ID
- 17-19-490
- Keywords
- Fruits and Vegetables, Inflammation, Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Collaborators
- University of North Texas Health Science Center
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 12 Mar 2022 (estimated)
- Study completion
- 12 Mar 2023 (estimated)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomized to experimental or placebo controlled condition
| Arm | Type | Receives |
|---|---|---|
| Juice Plus+ | Experimental | Dietary Supplement: 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. |
| Placebo | Placebo comparator | Dietary Supplement: Juice Plus+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. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • Men and women ≥55 years old will be eligible participants
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Juice Plus+Participants will receive encapsulated fruit and vegetable juice concentrates or a placebo for a 24-month period | Dietary supplement | Juice Plus+, Placebo |
Primary outcome
Change in Interleukin -5
Time frame: Baseline, Year, 1, and Year 2.
Interleukin -5 pg/mL
Change in serum Amyloid A
Time frame: Baseline, Year, 1, and Year 2.
Serum Amyloid A pg/mL
Change in Interleukin 6
Time frame: Baseline, Year, 1, and Year 2.
Interleukin 6 pg/mL
Change in C-reactive protein
Time frame: Baseline, Year, 1, and Year 2.
C-reactive protein pg/mL
3 secondary outcomes
Auditory Very Learning Test
Time frame: Baseline, 6-months, 12-months, 18-months, and 24-months
Stroop Test
Time frame: Baseline, 6-months, 12-months, 18-months, and 24-months
Trial Making task
Time frame: Baseline, 6-months, 12-months, 18-months, and 24-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No. Individual data will not be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raheem Paxton, PhD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juice Plus+ in people with Cognitive Impairment and Alzheimer Disease, Early Onset, run by University of Alabama, Tuscaloosa at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raheem Paxton, PhD (205-348-6857, rpaxton@ua.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Interleukin -5 (time frame: Baseline, Year, 1, and Year 2.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.