Actively Recruiting
Cranberry Polyphenols and Human Stress Resilience: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Integrating Cognitive, Physiological, and Microbiome Adaptations Underlying Nutritional Neuroprotection and Multitasking Performance in Healthy Adults
Led by University of Florida · Updated on 2026-03-06
84
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of daily cranberry juice consumption over 70 days on cognitive performance, motor accuracy, and stress responses during a multitasking challenge in healthy adults aged 30 to 55 years. The study aims to see if cranberry juice improves multitasking abilities, reduces stress and fatigue, and positively affects mood and cognitive function. Additionally, it explores whether cranberry juice influences gut microbiota and microbial metabolites, linking these changes to cognitive and stress-related benefits. This randomized, double-blind, placebo-controlled clinical trial involves two groups: one consuming cranberry juice and the other receiving a placebo juice that matches in appearance and taste but lacks active cranberry components. The study lasts 13 weeks and includes a run-in phase with dietary restrictions, followed by three in-person visits: consent, baseline, and final visit. At the final visit, participants consume the assigned beverage with a standardized meal. Daily intake of the beverage continues for 70 days during the intervention phase. Participants undergo assessments at baseline and final visits, including cognitive and motor multitasking tests, mood and stress questionnaires, saliva sampling for cortisol and alpha-amylase, and blood and fecal sample collection to analyze biomarkers and gut microbiome. Continuous physiological monitoring occurs during tasks, and standardized cognitive tests are administered. Compliance with dietary restrictions and beverage intake is tracked. The study measures include cognitive task accuracy and errors, mood, anxiety, fatigue, sleep quality, and various physiological stress markers, with participant involvement lasting about 13 weeks.
CONDITIONS
Brief Title
Cranberry Polyphenols and Stress Resilience During Multitasking in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Weigh at least 110 pounds
- Be between 30 and 55 years old
- Have a body mass index (BMI) between 18.9 and 29.9 kg/m²
- Have completed at least a high school education
You will not qualify if you...
- Consume more than 300 mg of caffeine or more than two cups of coffee per day
- Drink more than three alcoholic drinks per week
- Have a smoking history of 10 years or more or currently use cannabis products
- Have uncontrolled high blood pressure
- Have diagnosed diabetes, cardiovascular disease, neurological disorders, or mental health conditions
- Take prescribed anti-inflammatory medications, antibiotics, or antidepressants affecting study outcomes
- Regularly take vitamin or mineral supplements and unwilling to stop during the study
- Have specific dietary restrictions preventing consumption of the study's standardized breakfast
- Score 21 or higher on Beck's Depression Inventory or Beck's Anxiety Inventory
- Have a history of severe suicidal tendencies or seasonal depression
- Are pregnant or breastfeeding and unwilling to comply with pregnancy testing and tracking
- Have taken anti-inflammatory medications, antibiotics, or antidepressants within 3 months before the study
- Previously enrolled in IRB#202300950 due to learning effects on cognitive tests
- Unable to complete the on-site multitasking screening task
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility checks
Duration - Up to 2 weeks between consent and baseline visit
Participants follow dietary restrictions avoiding cranberry products, certain polyphenol-rich foods, caffeine, and alcohol before baseline.
No visits during this period
Duration - 70 days
Participants consume either cranberry juice or placebo daily for 70 days while continuing study procedures.
2 in-person visits: baseline and final visit
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
M
Maya E Waintraub, M.S.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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