NCT07453537 Cranberry Polyphenols and Stress Resilience During Multitasking in Healthy Adults
| NCT ID | NCT07453537 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Stress Response |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2028-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2026-04-01 with a primary completion date of 2028-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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
Contact & Investigator
Lewei Gu, PhD
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT07453537 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 55 Years, studying Stress Response. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07453537 currently recruiting?
Yes, NCT07453537 is actively recruiting participants. Contact the research team at mwaintraub@ufl.edu for enrollment information.
Where is the NCT07453537 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT07453537 clinical trial?
NCT07453537 is sponsored by University of Florida. The principal investigator is Lewei Gu, PhD at University of Florida. The trial plans to enroll 84 participants.