Cranberry Polyphenols and Stress Resilience During Multitasking in Healthy Adults

NCT07453537 | Recruiting

• 1 other identifier: IRB 202500138
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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; Motor Activity

Outcome Measures

Primary Outcomes (2)

• Cognitive task performance (serial subtraction accuracy)

  Total number of correct subtractions during the multitasking cognitive task Measure Description: Counting backward aloud from a random number between 800-999 by 3, 7, and 17; performance scored as total correct subtractions across the task.

  Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).

• Cognitive task performance (serial subtraction errors)

  Outcome Measure: Total number of incorrect subtractions during the multitasking cognitive task Measure Description: Same serial subtraction task; performance scored as total incorrect subtractions.

  Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).

Secondary Outcomes (19)

• Mood

  Baseline (Visit 2; pre- and post-multitasking task) and Final (Visit 3, Day 70; pre- and post-multitasking task). Through study completion (average of 2 years).

• State anxiety

  Baseline (Visit 2; pre- and post-multitasking task) and Final (Visit 3, Day 70; pre- and post-multitasking task). Through study completion (average of 2 years).

• Mental fatigue

  Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).

• Sleep quality

  Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).

• Trait anxiety

  Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).

Other Outcomes (2)

• Gut microbiome composition and diversity

  Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).

• Short-chain fatty acids (SCFAs)

  Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).

Study Arms (2)

Cranberry juice

EXPERIMENTAL

Cranberry juice will be provided by Ocean Spray Company.

Other: Cranberry juice

Placebo cranberry juice

PLACEBO COMPARATOR

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.

Other: Placebo juice

Interventions

Cranberry juice OTHER

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

Cranberry juice

Placebo juice OTHER

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

Placebo cranberry juice

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

MeSH Terms

Conditions

Fractures, Stress; Stress, Psychological; Multitasking Behavior; Neurobehavioral Manifestations; Motor Activity

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Behavioral Symptoms; Behavior; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lewei Gu, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya E Waintraub, M.S.

CONTACT

847-246-2255; mwaintraub@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study coordinator and staff are also blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel-group, randomized, double-blind, placebo-controlled human intervention study in healthy adults aged 30-55.

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: March 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: March 6, 2026

Record last verified: 2026-01

Locations

US (1)