Recruiting

Cranberry Juice

Sponsor:

University of Florida

Code:

NCT07453537

Conditions

Stress Response

Mental Stress

Multitasking Behavior and Multitasking Ability

Physiological Stress

Cognitive Symptoms

Eligibility Criteria

Sex: All

Age: 30 - 55

Healthy Volunteers: Accepted

Interventions

Cranberry juice

Placebo juice

Study Details

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).

Conditions

Stress Response

Mental Stress

Multitasking Behavior and Multitasking Ability

Physiological Stress

Cognitive Symptoms

Study ID

NCT07453537

Start date

Aug 1, 2026

Status verified date

Jan, 2026

Completion date

Aug 1, 2029

Anticipated

Primary completion date

May 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Cranberry juice

Cranberry juice will be provided by Ocean Spray Company.

placebo comparator: Placebo cranberry juice

Placebo juice will be provided from Ocean Spray Company to match the appearance, taste, and calories of the cranberry beverage; it contains no active cranberry components.

Interventions

Cranberry juice

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

Placebo juice

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

Primary outcome measure

  • Cognitive task performance (serial subtraction accuracy) [ Time Frame: Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years). ]
  • Cognitive task performance (serial subtraction errors) [ Time Frame: Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years). ]

Central Contacts and Locations

Central contacts

Maya E Waintraub, M.S.

847-246-2255mwaintraub@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Maya Waintraub, M.S.

847-246-2255mwaintraub@ufl.edu

Principal Investigator:

lewei Gu, PhD

More Information

Sponsor

University of Florida

Last update posted

Jun 30, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-06-30.