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.
University of Florida
Summary
This randomized, double-blind, placebo-controlled clinical trial evaluates whether 70 days of daily cranberry juice consumption improves cognitive performance and motor accuracy and reduces psychological and physiological stress responses during a motor-cognitive dual-task multitasking challenge in healthy adults aged 30-55 (Aim 1). It is hypothesized that chronic cranberry juice intake will enhance dual-task performance and attenuate stress reactivity (Hypothesis 1). It is further hypothesized that cranberry juice will mitigate multitasking-related fatigue, mood fluctuations, and cognitive impairment, accompanied by favorable changes in circulating stress biomarkers and stress-regulatory neurochemical pathways (Aim 2/Hypothesis 2). Finally, the study incorporates gut analysis to determine whether cranberry juice induces beneficial shifts in the gut microbiota and microbial metabolites (e.g., SCFAs) and whether these changes are associated with improved cognitive and stress-related outcomes, consistent with a microbiome-gut-brain axis mechanism (Aim 3/Hypothesis 3).
Description
Recruitment and Screening Individuals who express interest will complete an initial study interest form. If preliminarily qualified, individuals will proceed to a screening process conducted via Qualtrics. Study staff will review responses to confirm eligibility and identify exclusions based on predefined criteria. Study Design, Visits, and Timeline This randomized, double-blind, placebo-controlled, parallel-design trial spans 13 weeks and includes three in-person visits: the consent visit (V1), the baseline visit (V2), and the final visit (V3). Consent Visit (V1) At V1, participants comp…
Eligibility
- Age range
- 30–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * At least 110 pounds * Between 30 and 55 years * BMI between 18.9 and 29.9 kg/m² * A minimum education level of high school or above Exclusion Criteria: * Heavy caffeine users (consuming more than 300 mg/day or more than two cups of coffee per day) * Alcohol consumption exceeding three drinks per week * A smoking history of 10 years or more, or current use of cannabis products * Uncontrolled hypertension * Clinically diagnosed illnesses such as diabetes, cardiovascular disease, neurological disorders, or mental health conditions * Participants currently taking prescribe…
Interventions
- OtherCranberry juice
Participants will consume the cranberry juice beverage by mouth each day for 70 days following a run-in period.
- OtherPlacebo juice
Participants will consume the placebo cranberry juice beverage by mouth each day for 70 days following a run-in period.
Location
- University of FloridaGainesville, Florida