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Stress ResponseCRAN-MULTINCT07453537

Cranberry Polyphenols and Stress Resilience During Multitasking in Healthy Adults

A study testing Cranberry juice in people with Stress Response and Mental Stress, run by University of Florida at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 55 yearsHealthy volunteers can take part
What is being tested?
Cranberry juice
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteUnited States
Study dates
1 Aug 2026to 1 Aug 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maya E Waintraub, M.S. contact

847-246-2255

mwaintraub@ufl.edu

United States1 site, 1 recruiting
  • University of Florida

    Gainesville, Florida, 32608

    Maya Waintraub, M.S., 847-246-2255, mwaintraub@ufl.edu

    lewei Gu, PhD

    Recruiting

Other trials in United States

About this study

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.

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).

Read the detailed 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 complete the informed consent process and undergo eligibility checks. These include measurement of height and weight to confirm BMI eligibility, pregnancy testing for female participants to ensure non-pregnant status, and a brief multitasking task capability check to confirm participants can comfortably perform the protocol tasks. Study staff will answer any questions, and V2 and V3 will be scheduled. Upon providing consent, participants enter the run-in phase.

Run-In Phase (Pre-Baseline)

Following V1, participants begin the run-in phase, adhering to the study's dietary restrictions. This includes avoiding cranberry products and specific polyphenol- or supplement-rich foods, as well as limiting caffeine and alcohol near visit days.

Baseline Visit (V2) and Final Visit (V3) Procedures

V2 (baseline) and V3 (final) follow the same structure, with the key difference being the assigned beverage at breakfast during V3.

Pre-Visit Requirements and Intake

Participants arrive after a 10-hour overnight fast. Upon arrival, participants submit a self-collected fecal sample for gut microbiome analysis. Compliance with dietary restrictions is confirmed, after which a phlebotomist draws a fasting blood sample (20 mL). Height and weight are measured.

Core Assessments (V2 and V3)

Multitasking (Dual-Task) Challenge and Stress Reactivity Participants perform a dual-task multitasking paradigm with continuous physiological monitoring. The cognitive task involves counting backward aloud from a random number between 800 and 999, subtracting by 3, 7, and 17 across three series. Each series lasts 4 minutes, with 90-second breaks in between, totaling 15 minutes. Scoring is based on the total correct/incorrect subtractions; if errors occur, participants continue from the new number. The motor task involves clicking rapidly shrinking dots on a screen, scored for target efficiency and accuracy. The multitasking session is video-recorded. Mood and stress are assessed using the State-Trait Anxiety Inventory (STAI-State) and Visual Analog Mood Scales (VAMS) immediately before and after the task. Saliva samples are collected immediately before, immediately after, and 60 minutes after the task to measure cortisol and alpha-amylase.

Standardized Meal (V2 vs. V3)

At V2, participants are served a standardized meal with water. At V3 (Day 70), the standardized meal remains the same, but water is replaced with 8 oz of the assigned beverage (either cranberry juice or placebo).

Cognitive Testing

Following the multitasking challenge and standardized meal, participants complete NIH Toolbox cognition and memory assessments.

Questionnaires and Symptom Monitoring

Participants complete measures assessing mental fatigue, perceived stress, and trait anxiety via Qualtrics.

Post-Visit and Follow-Up

After V2, participants leave with assigned beverages (8 oz per bottle; two bottles per day). V3, the final visit, mirrors V2, except the standardized meal includes 8 oz of the assigned beverage and an additional compliance questionnaire is administered. Participation ends after all final assessments are completed at V3.

Being tested
Cranberry juice, Placebo juice
Medical subject headings
Fractures, Stress, Stress, Psychological, Multitasking Behavior, Neurobehavioral Manifestations, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cranberry juiceOther

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

  • Placebo juiceOther

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

Study groups in NCT07453537
Study groupRoleWhat they receive
Cranberry juiceExperimentalCranberry juice will be provided by Ocean Spray Company.
Receives: Other: Cranberry juice
Placebo cranberry juicePlacebo comparatorPlacebo 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.
Receives: Other: Placebo juice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (19)
  1. Mood

    Change from baseline to end of intervention in mood assessed using the Visual Analog Mood Scale (VAMS). The VAMS is a self-report visual analog measure of current mood states collected during study visits per protocol.

    Measured: 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).

  2. State anxiety

    Change from baseline to end of intervention in state anxiety assessed using the State-Trait Anxiety Inventory - State Subscale (STAI-State). The STAI-State is a self-report measure assessing state anxiety in response to multitasking stress collected during study visits per protocol.

    Measured: 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).

  3. Mental fatigue

    Change from baseline to end of intervention in mental fatigue assessed using the Mental Fatigue Scale (MFS). The MFS is a self-reported questionnaire evaluating perceived mental fatigue and related cognitive symptoms. Scores will be collected during study visits and analyzed per protocol to assess changes following cranberry juice intervention.

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

  4. Sleep quality

    Change from baseline to end of intervention in sleep quality assessed using the Leeds Sleep Evaluation Questionnaire (LSEQ). The LSEQ is a self-report questionnaire evaluating subjective sleep quality and related dimensions of sleep and awakening, collected during study visits per protocol.

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

  5. Trait anxiety

    Change from baseline to end of intervention in trait anxiety assessed using the State-Trait Anxiety Inventory - Trait Subscale (STAI-Trait). The STAI-Trait is a self-report measure of trait anxiety.

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

  6. Food frequnecy questionnaire

    Dietary intake patterns assessed using a Food Frequency Questionnaire (FFQ). The FFQ is a self-report measure used to evaluate habitual dietary intake and food consumption frequency during the run-in phase and throughout the intervention period per protocol.

    Measured: Run-in (pre-intervention), Baseline (Visit 2), Mid-Intervention, and Day 70 (Visit 3). Through study completion (average of 2 years).

  7. Picture vocabulary test

    NIH Toolbox Picture Vocabulary Test: to assess participants' ability to understand and identify the meaning of words by matching them to corresponding images.

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

  8. Flanker inhibitory control and attention test

    NIH Toolbox Flanker Inhibitory Control and Attention Test: to assess participants' cognitive control and attentional processes, specifically their ability to inhibit irrelevant information and focus on the relevant stimuli.

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

  9. List sorting working memory test

    NIH Toolbox List Sorting Working Memory Test: to assess participants' working memory abilities.

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

  10. Dimensional changes card sort test

    NIH Toolbox Dimensional Changes Card Sort Test: to assess the cognitive flexibility of participants.

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

  11. Pattern comparison processing speed test

    NIH Toolbox Pattern Comparison Processing Speed Test: to assess the cognitive processing speed of participants.

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

  12. Picture sequence memory test

    NIH Toolbox Picture Sequence Memory Test: to assess participants' episodic memory.

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

  13. Auditory verbal learning test

    Auditory Verbal Learning Test: to assess participants' attention, memory, and learning ability in the auditory-verbal domain.

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

  14. Picture sequence memory test

    NIH Toolbox Picture Sequence Memory Test: to assess participants' episodic memory.

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

  15. Heart rate

    Heart rate (bpm) will be measured during multitasking.

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

  16. Interbeat interval (IBI)

    Interbeat interval (ms) will be measured during multitasking.

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

  17. Galvanic skin response (GSR)

    Galvanic skin response (μS) will be measured during multitasking.

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

  18. Salivary alpha-amylase activity

    Salivary alpha-amylase activity will be assessed using ELISA kit.

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

  19. Salivary cortisol level

    Salivary cortisol level will be measured by an enzyme immunoassay with the Cortisol Elisa Assay Kit.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 May 2028 (estimated)
  4. Study completion1 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel-group, randomized, double-blind, placebo-controlled human intervention study in healthy adults aged 30-55.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07453537
Sponsor's protocol ID
IRB 202500138
Acronym
CRAN-MULTI
Status last verified
Jan 2026
First submitted
26 Jan 2026
Last updated
30 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Cranberry juice in people with Stress Response and Mental Stress, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maya E Waintraub, M.S. (847-246-2255, mwaintraub@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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