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RECRUITING

NCT07453537

Cranberry Polyphenols and Stress Resilience During Multitasking in Healthy Adults

Sponsor: University of Florida

View on ClinicalTrials.gov

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).

Official title: 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.

Key Details

Gender

All

Age Range

30 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-01

Completion Date

2029-08-01

Last Updated

2026-03-06

Healthy Volunteers

Yes

Conditions

Stress Response Mental Stress Multitasking Behavior and Multitasking Ability Physiological Stress Cognitive Symptoms Motor Activity

Interventions

OTHER

Cranberry juice

Participants will consume the cranberry juice beverage by mouth each day for 70 days following a run-in period.

OTHER

Placebo juice

Participants will consume the placebo cranberry juice beverage by mouth each day for 70 days following a run-in period.

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 prescribed anti-inflammatory medications, antibiotics, or antidepressants that may affect study outcomes, particularly those related to blood and fecal sample analysis * Individuals who regularly take vitamin or mineral supplements and are unwilling to discontinue them for the duration of the study will not qualify. * Participants must be willing to maintain their current daily routine and lifestyle, undergo body weight and height measurements, and notify study coordinators of any illnesses or significant adverse life events during the study period * Those with specific dietary restrictions that prevent them from consuming the standardized breakfast sandwich required in the study protocol * Participants must successfully complete the on-site multitasking task as a screening measure prior to signing consent. * Beck's Depression Inventory score of 21 or higher * Beck's Anxiety Inventory score of 21 or higher * A history of severe suicidal tendencies, or seasonal depression * Pregnancy and breastfeeding (Female participants must complete four pregnancy tests throughout the study and track their menstrual cycle. Those unwilling to comply with these requirements will not be eligible.) * Potential participants must not have taken any anti-inflammatory medications, antibiotics, or antidepressants within the past three months prior to the start of the study * Individuals who were previously enrolled in IRB#202300950 will be excluded due to the learning effect of cognitive tests, ensuring accurate data collection for this study

Locations (1)

University of Florida

Gainesville, Florida, United States