Stress ResponseNCT06066619
Can Cranberry Juice Enhance the Cognition Accuracy and Alleviate Negative Mental Consequences During Multitasking?
A study testing Cranberry Juice A and Cranberry Juice B in people with Stress Response and Multitasking Behavior, run by University of Florida at 1 site in United States.
Trial summary
This clinical trial aims to investigate the effects of a 70-day consumption of cranberry juice on cognitive and motor accuracy, mental and physiological stress, and stress response in healthy men and women between the ages of 30 and 55 who engage in multitasking. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Response, Multitasking Behavior, Mental Stress
- What is being tested?
- Cranberry Juice A and Cranberry Juice B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2024to 10 Jun 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Weight ≥110 pounds;
- Age 30-55;
- BMI 18.9-29.9 kg/m^2;
- Education level high school and above
Who cannot join
- Heavy caffeine user (>300 mg caffeine/day or more than 2 cups of coffee/day);
- Alcohol consumption (>3 alcohol/week);
- Smoking (≥10 years);
- Taking cannabis products;
- Uncontrolled hypertension;
- Clinically diagnosed illnesses, such as diabetes, cardiovascular disease, neurological disorders, and mental diseases;
Show all 20Show fewer
- Taking medications (antibiotics, etc.) that may influence study outcomes;
- Taking vitamin/mineral supplements and are not willing to stop for the duration of the study;
- Have specific dietary restriction (prevent from consuming the standardized breakfast or dinner sandwiches);
- Inability to perform multitasking;
- Inability to do blood collection on arm;
- Inability to being video recorded while performing multitasking;
- Inability to comply with dietary restrictions for the entire duration of the study;
- Beck's depression inventory score of ≥21 during screening;
- Beck's anxiety inventory score ≥21 during screening;
- Severe suicidal tendencies (≥2);
- Having seasonal depression;
- Pregnancy;
- Breast-feeding;
- Female participants will do four pregnancy tests and their menstruation cycle need to be recorded. Female participants who do not wish to do pregnancy tests or record their menstruation cycle will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Food/Environment Toxicology Lab
Gainesville, Florida, 32608
About this study
Official title: Can Cranberry Juice Enhance the Cognition and Motor Accuracy During Multitasking and Alleviate Some Negative Mental and Physiological Consequences of Intense Multitasking in Healthy Adults?
This clinical trial aims to investigate the effects of a 70-day consumption of cranberry juice on cognitive and motor accuracy, mental and physiological stress, and stress response in healthy men and women between the ages of 30 and 55 who engage in multitasking. The trial will utilize a randomized, double-blinded, placebo-controlled design. It is worth noting that studies have shown that over half of middle-aged Americans experience stress, which can lead to cognitive decline and depression. Previous clinical trials have indicated that consuming polyphenol-rich foods can have positive effects on cognitive function in humans. However, no study to date has examined the long-term effects of cranberry juice consumption on cognitive performance, mental stress, and stress response specifically in individuals engaged in multitasking. Based on this gap in knowledge, the investigators hypothesize the following: (1) chronic consumption of cranberry juice will improve cognitive and motor accuracy, as well as mental and psychological stress responses in young adults subjected to intense multitasking. (2) cranberry juice consumption will alleviate the negative consequences of frequent intense multitasking, such as fatigue, mood fluctuations, cognitive impairment, and memory issues. Additionally, it is expected to have a positive impact on stress biomarkers and neurotransmitter levels. By conducting this clinical trial, the investigators aim to shed light on the potential benefits of cranberry juice consumption in improving cognitive performance, mitigating mental stress, and positively influencing stress responses in individuals who engage in intense multitasking.
Read the detailed description
Recruitment Process (Screening Process):
Potential participants who have expressed interest in participating in the study will need to complete the recruitment process (or screening process). The recruitment process contains four questionnaires: Beck's Anxiety Inventory, Beck's Depression Inventory, Columbia-Suicide Severity Rating Scale, and Screening Questionnaire. The investigators will meticulously review these questionnaires to assess the eligibility of potential participants. Potential participants who meet the criteria for participation will be invited to a Consent visit (V1) to sign the consent form formally. Conversely, if potential participants do not meet the study's qualifications, the investigators will promptly communicate the results and securely dispose of the questionnaires containing their personal information.
There will be a total of three visits (V1, V2, and V3) in this study.
- V1: Consent visit
- V2: Baseline visit
- V3: Final visit
Participants who have completed the recruitment process and are qualified for the study will need to visit the lab in person and complete the consent process (V1). During V1, participants will have enough time to complete the consent. If the participants have any questions or concerns, the investigators will provide them with the necessary information and clarification. Also, the investigators will schedule the V2 and V3 with the participants. Upon signing the consent form, participants will enter the run-in phase of the study.
Run-in phase (Day -20 - Day 0):
- Participants will start to follow the dietary restriction.
Baseline visit (V2) \& final visit (V3) (Day 0 - Day 70)
- Participants will visit the lab on the last day of the run-in period.
- Participants need to fast (10 h) before the blood collection.
- Participants need to provide fecal samples.
- Participants will complete a 24-hour food record by The Automated Self-Administered 24-Hour Dietary Assessment Tool and a dietary questionnaire on a computer.
- Participants' body height and weight will be measured.
- A phlebotomist will collect participants' fasting blood (20 mL).
- Participants will be served a standardized breakfast with a cup of water (V2) or assigned juice (V3).
- Tasks participants are going to complete:
- Multitasking tasks (Participants will count backward, first by 3 (Series 1), then by 7 (Series 2), and finally by 17 (Series 3) from a randomly chosen number within the 800 to 999 range. At the same time, participants will encounter rapidly diminishing dots on a computer screen and use a mouse to click on these dots as they appear. There will be a total of three series of tasks, each lasting 4 minutes, with 90-second breaks provided between each series. The entire session will span 15 minutes in total), State-trait anxiety inventory state, VAMS, heart rate, galvanic skin response, and saliva sample collection.
- NIH toolbox tests for cognition memory, attention, and learning ability.
- Assessment of emotional well-being, mental resilience, and sleep quality, and monitor participants' frustration levels, anxiety traits, mood fluctuations, stress levels, and depressive and suicidal tendencies.
V2 only: after all the tests, participants are free to leave the lab with two weeks' supply of assigned beverages (8 oz/per bottle and one bottle per day). Participants will return to the lab every other week to pick up cranberry or placebo juice. Participants will also return the empty bottle and report to study coordinators if there are any side effects or other issues. A compliance calendar will be provided to participants to remind their dietary restrictions and schedule. A token of appreciation will be given to participants every four weeks to reward compliance.
V3 only: after all the tests, participants are free to leave the lab, and their study is completed.
- Conditions
- Stress Response, Multitasking Behavior, Mental Stress, Physiological Stress, Cognitive Symptom, Motor Activity
- Being tested
- Cranberry Juice A, Cranberry Juice B, Placebo Juice
- Medical subject headings
- Fractures, Stress, Multitasking Behavior, Stress, Psychological, Neurobehavioral Manifestations, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry Juice ADietary supplement
Cranberry juices will be provided by Ocean Spray Company.
Cranberry Juice BDietary supplement
Cranberry juices will be provided from Ocean Spray Company.
Placebo JuiceDietary supplement
Placebo juice will be provided from Ocean Spray Company to match the appearance, taste, and calories of the cranberry juice.
| Study group | Role | What they receive |
|---|---|---|
| Cranberry Juice A | Experimental | Cranberry juice A Receives: Dietary Supplement: Cranberry Juice A |
| Cranberry juice B | Experimental | Cranberry juice B Receives: Dietary Supplement: Cranberry Juice B |
| Placebo juice | Placebo comparator | Placebo juice that matches the appearance, taste, and calories of the treatment juices. Receives: Dietary Supplement: Placebo Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Heart rate (bpm) will be measured during multitasking.
Measured: In baseline visit, for 15 minutes during multitasking; in final visit, for 15 minutes during multitasking. Through study completion, an average of 2 years.
Galvanic Skin Response
Galvanic skin response (micro-Siemens) will be measured during multitasking.
Measured: In baseline visit, for 15 minutes during multitasking; in final visit, for 15 minutes during multitasking. Through study completion, an average of 2 years.
Salivary alpha-amylase activity
Salivary alpha-amylase activity will be assessed using ELISA kit.
Measured: Through study completion, an average of 2 years.
Salivary cortisol level
Salivary cortisol level will be measured by an enzyme immunoassay with the Cortisol Elisa Assay Kit.
Measured: Through study completion, an average of 2 years.
1. Assessment of Anxiety
Beck's Anxiety Inventory (BAI): presence and intensity of anxiety-related thoughts. During the recruitment process (screening process), potential participants who are having Beck's anxiety inventory score ≥21 will be excluded from this study.
A higher score means a higher level of anxiety.
Minimum Value: 0 Maximum Value: 63
Measured: During the recruitment process (screening process), potential participants are required to take 3-5 minutes to complete the BAI. Through study completion, an average of 2 years.
2. Assessment of Anxiety
State-Trait Anxiety Inventory (STAI):
- STAI anxiety state (STAI state): the current feeling of anxiety;
- STAI anxiety trait (STAI trait): the personality trait of anxiety.
A higher score means a higher level of anxiety.
Minimum Value: 20 Maximum Value: 80
Measured: During the baseline and final visits, participants are required to take 3-5 minutes to complete the STAI state and STAI trait. Through study completion, an average of 2 years.
1. Assessment of Mood
Mental fatigue scale (MFS): mental fatigue.
A higher score means a higher level of mental fatigue.
Minimum Value: 0 Maximum Value: 42
Measured: During the baseline and final visits, participants are required to take 3-5 minutes to complete the MFS after NIH toolbox tests. Through study completion, an average of 2 years.
2. Assessment of Mood
Visual analog mood scales (VAMS): the current mood.
A higher score means a higher level of alert. A higher score means a higher level of inattentive. A higher score means a higher level of strong. A higher score means a higher level of weak. A higher score means a higher level of well-coordinated. A higher score means a higher level of disorganized. A higher score means a higher level of lethargic. A higher score means a higher level of energetic. A higher score means a higher level of incompetent. A higher score means a higher level of competent. A higher score means a higher level of happy. A higher score means a higher level of sad. A higher score means a higher level of interested. A higher score means a higher level of bored. A higher score means a higher level of mentally slow. A higher score means a higher level of quick-witted.
Minimum Value: 0 Maximum Value: 100
Measured: During the baseline and final visits, participants are required to take 3-5 minutes to complete the VAMS after NIH toolbox tests. Through study completion, an average of 2 years.
Assessment of Depression
Beck's depression inventory (BDI): the feeling of depression. During the recruitment process (screening process), potential participants who are having Beck's depression inventory score ≥21 will be excluded from this study.
A higher score means a higher level of depression.
Minimum Value: 0 Maximum Value: 63
Measured: Participants are required to take 3-5 minutes to complete the BDI during recruitment process, baseline, and final visits. Through study completion, an average of 2 years.
Assessment of Stress
Perceived stress scale (PSS): the feeling of stress.
A higher score means a higher level of stress.
Minimum Value: 0 Maximum Value: 40
Measured: During the baseline and final visits, participants are required to take 3-5 minutes to complete the PSS after NIH toolbox tests. Through study completion, an average of 2 years.
Sleep Assessment
Leeds sleep evaluation (LSE): sleep assessment.
Participants will place marks on a group of 10-cm lines representing they have experienced in variety of symptoms of sleep. Lines extend between extremes like "more difficult than usual" and "easier than usual". Responses are measured using a 100-mm scale and are then averaged to provide a score for each domain. Theses can then be used to evaluate the efficacy and sleep-related side effects of juices.
Measured: During the baseline and final visits, participants are required to take 3-5 minutes to complete the LSE after NIH toolbox tests. Through study completion, an average of 2 years.
Suicide Severity Assessment
Columbia-Suicide Severity Rating Scale (CSSRS): suicide severity rating. During the recruitment process (screening process), potential participants who are having CSSRS (answer YES to actually having thoughts about killing yourself and thinking about you might do this) will be excluded from this study. Also, appropriate actions will be taken to ensure participants safety and well-being. For example, immediately contact a specified consultant and refer the participants who with high level of suicidality to the Crisis Hot Line. Suicidal assessments will also be assessed in V2 and V3 to ensure the participants do not have any suicidal tendencies. In sum, the assessment of suicidal should be completed immediately following the completion of the instruments.
Measured: During the recruitment process, baseline, and final visits, participants are required to take 2 minutes to complete the CSSRS. Through study completion, an average of 2 years.
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: During the baseline and final visits, participants are required to take about 10-15 minutes to complete the Picture Vocabulary Test. Through study completion, an average of 2 years.
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: During the baseline and final visits, participants are required to take about 10-15 minutes to complete the Flanker Inhibitory Control and Attention Test. Through study completion, an average of 2 years.
List Sorting Working Memory Test
NIH Toolbox List Sorting Working Memory Test: to assess participants' working memory abilities.
Measured: During the baseline and final visits, participants are required to take about 10-15 minutes to complete the List Sorting Working Memory Test. Through study completion, an average of 2 years.
Dimensional Changes Card Sort Test
NIH Toolbox Dimensional Changes Card Sort Test: to assess the cognitive flexibility of participants.
Measured: During the baseline and final visits, participants are required to take about 10-15 minutes to complete the Dimensional Changes Card Sort Test. Through study completion, an average of 2 years.
Pattern Comparison Processing Speed Test
NIH Toolbox Pattern Comparison Processing Speed Test: to assess the cognition processing speed of participants.
Measured: During the baseline and final visits, participants are required to take about 10-15 minutes to complete the Pattern Comparison Processing Speed Test. Through study completion, an average of 2 years.
Picture Sequence Memory Test
NIH Toolbox Picture Sequence Memory Test: to assess participants' episodic memory.
Measured: During the baseline and final visits, participants are required to take about 10-15 minutes to complete the Picture Sequence Memory Test. Through study completion, an average of 2 years.
Auditory Verbal Learning Test
Auditory Verbal Learning Test: to assess participants' attention, memory, and learning ability in the auditory-verbal domain.
Measured: During the baseline and final visits, participants are required to take about 40-50 minutes to complete the Auditory Verbal Learning Test. Through study completion, an average of 2 years.
Fecal Content of Acetic acid, Propionic acid, and Butyric acid
Fecal content of acetic acid, propionic acid, and butyric acid will be determined using gas chromatography with a flame ionization detector.
Measured: Participants are required to provide their fecal samples on the baseline and final visit. Through study completion, an average of 2 years. Through study completion, an average of 2 years.
Brain-derived neurotrophic factor (BDNF) Levels in Plasma
BDNF levels in plasma will be measured using ELISA kit.
Measured: A certified nurse will perform a blood draw for participants during both the baseline and final visits, using two tubes, resulting in a total of 20 mL. Through study completion, an average of 2 years.
Neurotransmitters Analysis
Monoamine oxidase (MAO) activity in plasma will be determined using the Amplex Red MAO Assay Kit.
Measured: A certified nurse will perform a blood draw for participants during both the baseline and final visits, using two tubes, resulting in a total of 20 mL. Through study completion, an average of 2 years.
1. Neurotransmitters Analysis
Plasma levels of tryptophan metabolites (3-indole propionic acid, Indole-3-aldehyde , Serotonin, and Melatonin) will be quantified using the targeted metabolomic method.
Measured: A certified nurse will perform a blood draw for participants during both the baseline and final visits, using two tubes, resulting in a total of 20 mL. Through study completion, an average of 2 years.
2. Neurotransmitters Analysis
Plasma levels of catecholamines (Dopamine, Epinephrine, and Norepinephrine) will be quantified using the targeted metabolomic method.
Measured: A certified nurse will perform a blood draw for participants during both the baseline and final visits, using two tubes, resulting in a total of 20 mL. Through study completion, an average of 2 years.
3. Neurotransmitters Analysis
Plasma levels of histamine will be quantified using the targeted metabolomic method.
Measured: A certified nurse will perform a blood draw for participants during both the baseline and final visits, using two tubes, resulting in a total of 20 mL. Through study completion, an average of 2 years.
4. Neurotransmitters Analysis
Plasma levels of Gamma-Aminobutyric acid (GABA) will be quantified using the targeted metabolomic method.
Measured: A certified nurse will perform a blood draw for participants during both the baseline and final visits, using two tubes, resulting in a total of 20 mL. Through study completion, an average of 2 years.
24-Hour Food Record
24-hour dietary record will be completed by participants using an Automated Self-Administered Dietary Assessment Tool.
Measured: During the baseline and final visits, participants are required to take about 10-15 minutes to complete the 24-Hour Food Record. Through study completion, an 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.
- First posted4 Oct 2023
- Study start10 Jan 2024
- Primary completion31 Jan 2025
- Study completion10 Jun 2028 (estimated)
Why it stopped: A coding error of testing beverages was discovered by study team
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ResponseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 126 healthy participants will be recruited. Inclusion criteria includes body weight ≥110 pounds, age 30-55, BMI 18.9-29.9 kg/m\^2, and education level high school and above. A stratified block randomization will be applied to separate participants into three different beverage groups. Three-digit codes will be assigned to different beverages. This coding process should be conducted by an individual who is not involved in the study. Maintain blinding by using the coded treatment labels during the study can help to eliminate potential biases in the assessment of outcomes.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066619
- Sponsor's protocol ID
- IRB202300950
- Status last verified
- Oct 2025
- First submitted
- 5 Sep 2023
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Cranberry Juice Enhance the Cognition and Motor Accuracy During Multitasking and Alleviate Some Negative Mental and Physiological Consequences of Intense Multitasking in Healthy Adults?
- ClinicalTrials.gov ID
- NCT06066619
- Acronym / sponsor ID
- IRB202300950
- Conditions
- Stress Response, Multitasking Behavior, Mental Stress, Physiological Stress, Cognitive Symptom, Motor Activity
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: A coding error of testing beverages was discovered by study team
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 10 Jun 2028 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to investigate the effects of a 70-day consumption of cranberry juice on cognitive and motor accuracy, mental and physiological stress, and stress response in healthy men and women between the ages of 30 and 55 who engage in multitasking. The trial will utilize a randomized, double-blinded, placebo-controlled design. It is worth noting that studies have shown that over half of middle-aged Americans experience stress, which can lead to cognitive decline and depression. Previous clinical trials have indicated that consuming polyphenol-rich foods can have positive effects on cognitive function in humans. However, no study to date has examined the long-term effects of cranberry juice consumption on cognitive performance, mental stress, and stress response specifically in individuals engaged in multitasking. Based on this gap in knowledge, the investigators hypothesize the following: (1) chronic consumption of cranberry juice will improve cognitive and motor accuracy, as well as mental and psychological stress responses in young adults subjected to intense multitasking. (2) cranberry juice consumption will alleviate the negative consequences of frequent intense multitasking, such as fatigue, mood fluctuations, cognitive impairment, and memory issues. Additionally, it is expected to have a positive impact on stress biomarkers and neurotransmitter levels. By conducting this clinical trial, the investigators aim to shed light on the potential benefits of cranberry juice consumption in improving cognitive performance, mitigating mental stress, and positively influencing stress responses in individuals who engage in intense multitasking.
Detailed description
Recruitment Process (Screening Process):
Potential participants who have expressed interest in participating in the study will need to complete the recruitment process (or screening process). The recruitment process contains four questionnaires: Beck's Anxiety Inventory, Beck's Depression Inventory, Columbia-Suicide Severity Rating Scale, and Screening Questionnaire. The investigators will meticulously review these questionnaires to assess the eligibility of potential participants. Potential participants who meet the criteria for participation will be invited to a Consent visit (V1) to sign the consent form formally. Conversely, if potential participants do not meet the study's qualifications, the investigators will promptly communicate the results and securely dispose of the questionnaires containing their personal information.
There will be a total of three visits (V1, V2, and V3) in this study.
- V1: Consent visit
- V2: Baseline visit
- V3: Final visit
Participants who have completed the recruitment process and are qualified for the study will need to visit the lab in person and complete the consent process (V1). During V1, participants will have enough time to complete the consent. If the participants have any questions or concerns, the investigators will provide them with the necessary information and clarification. Also, the investigators will schedule the V2 and V3 with the participants. Upon signing the consent form, participants will enter the run-in phase of the study.
Run-in phase (Day -20 - Day 0):
- Participants will start to follow the dietary restriction.
Baseline visit (V2) \& final visit (V3) (Day 0 - Day 70)
- Participants will visit the lab on the last day of the run-in period.
- Participants need to fast (10 h) before the blood collection.
- Participants need to provide fecal samples.
- Participants will complete a 24-hour food record by The Automated Self-Administered 24-Hour Dietary Assessment Tool and a dietary questionnaire on a computer.
- Participants' body height and weight will be measured.
- A phlebotomist will collect participants' fasting blood (20 mL).
- Participants will be served a standardized breakfast with a cup of water (V2) or assigned juice (V3).
- Tasks participants are going to complete:
- Multitasking tasks (Participants will count backward, first by 3 (Series 1), then by 7 (Series 2), and finally by 17 (Series 3) from a randomly chosen number within the 800 to 999 range. At the same time, participants will encounter rapidly diminishing dots on a computer screen and use a mouse to click on these dots as they appear. There will be a total of three series of tasks, each lasting 4 minutes, with 90-second breaks provided between each series. The entire session will span 15 minutes in total), State-trait anxiety inventory state, VAMS, heart rate, galvanic skin response, and saliva sample collection.
- NIH toolbox tests for cognition memory, attention, and learning ability.
- Assessment of emotional well-being, mental resilience, and sleep quality, and monitor participants' frustration levels, anxiety traits, mood fluctuations, stress levels, and depressive and suicidal tendencies.
V2 only: after all the tests, participants are free to leave the lab with two weeks' supply of assigned beverages (8 oz/per bottle and one bottle per day). Participants will return to the lab every other week to pick up cranberry or placebo juice. Participants will also return the empty bottle and report to study coordinators if there are any side effects or other issues. A compliance calendar will be provided to participants to remind their dietary restrictions and schedule. A token of appreciation will be given to participants every four weeks to reward compliance.
V3 only: after all the tests, participants are free to leave the lab, and their study is completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- A total of 126 healthy participants will be recruited. Inclusion criteria includes body weight ≥110 pounds, age 30-55, BMI 18.9-29.9 kg/m^2, and education level high school and above. A stratified block randomization will be applied to separate participants into three different beverage groups. Three-digit codes will be assigned to different beverages. This coding process should be conducted by an individual who is not involved in the study. Maintain blinding by using the coded treatment labels during the study can help to eliminate potential biases in the assessment of outcomes.
| Arm | Type | Receives |
|---|---|---|
| Cranberry Juice A | Experimental | Dietary Supplement: Cranberry Juice ACranberry juice A |
| Cranberry juice B | Experimental | Dietary Supplement: Cranberry Juice BCranberry juice B |
| Placebo juice | Placebo comparator | Dietary Supplement: Placebo JuicePlacebo juice that matches the appearance, taste, and calories of the treatment juices. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Weight ≥110 pounds;
- Age 30-55;
- BMI 18.9-29.9 kg/m^2;
- Education level high school and above
Key exclusion criteria (20 listed)
- Heavy caffeine user (>300 mg caffeine/day or more than 2 cups of coffee/day);
- Alcohol consumption (>3 alcohol/week);
- Smoking (≥10 years);
- Taking cannabis products;
- Uncontrolled hypertension;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranberry Juice ACranberry juices will be provided by Ocean Spray Company. | Dietary supplement | Cranberry Juice A |
| Cranberry Juice BCranberry juices will be provided from Ocean Spray Company. | Dietary supplement | Cranberry juice B |
| Placebo JuicePlacebo juice will be provided from Ocean Spray Company to match the appearance, taste, and calories of the cranberry juice. | Dietary supplement | Placebo juice |
Primary outcome
Heart Rate
Time frame: In baseline visit, for 15 minutes during multitasking; in final visit, for 15 minutes during multitasking. Through study completion, an average of 2 years.
Heart rate (bpm) will be measured during multitasking.
Galvanic Skin Response
Time frame: In baseline visit, for 15 minutes during multitasking; in final visit, for 15 minutes during multitasking. Through study completion, an average of 2 years.
Galvanic skin response (micro-Siemens) will be measured during multitasking.
Salivary alpha-amylase activity
Time frame: Through study completion, an average of 2 years.
Salivary alpha-amylase activity will be assessed using ELISA kit.
Salivary cortisol level
Time frame: Through study completion, an average of 2 years.
Salivary cortisol level will be measured by an enzyme immunoassay with the Cortisol Elisa Assay Kit.
1. Assessment of Anxiety
Time frame: During the recruitment process (screening process), potential participants are required to take 3-5 minutes to complete the BAI. Through study completion, an average of 2 years.
Beck's Anxiety Inventory (BAI): presence and intensity of anxiety-related thoughts. During the recruitment process (screening process), potential participants who are having Beck's anxiety inventory score ≥21 will be excluded from this study. A higher score means a higher level of anxiety. Minimum Value: 0 Maximum Value: 63
2. Assessment of Anxiety
Time frame: During the baseline and final visits, participants are required to take 3-5 minutes to complete the STAI state and STAI trait. Through study completion, an average of 2 years.
State-Trait Anxiety Inventory (STAI): 1. STAI anxiety state (STAI state): the current feeling of anxiety; 2. STAI anxiety trait (STAI trait): the personality trait of anxiety. A higher score means a higher level of anxiety. Minimum Value: 20 Maximum Value: 80
1. Assessment of Mood
Time frame: During the baseline and final visits, participants are required to take 3-5 minutes to complete the MFS after NIH toolbox tests. Through study completion, an average of 2 years.
Mental fatigue scale (MFS): mental fatigue. A higher score means a higher level of mental fatigue. Minimum Value: 0 Maximum Value: 42
2. Assessment of Mood
Time frame: During the baseline and final visits, participants are required to take 3-5 minutes to complete the VAMS after NIH toolbox tests. Through study completion, an average of 2 years.
Visual analog mood scales (VAMS): the current mood. A higher score means a higher level of alert. A higher score means a higher level of inattentive. A higher score means a higher level of strong. A higher score means a higher level of weak. A higher score means a higher level of well-coordinated. A higher score means a higher level of disorganized. A higher score means a higher level of lethargic. A higher score means a higher level of energetic. A higher score means a higher level of incompetent. A higher score means a higher level of competent. A higher score means a higher level of happy. A higher score means a higher level of sad. A higher score means a higher level of interested. A higher score means a higher level of bored. A higher score means a higher level of mentally slow. A higher score means a higher level of quick-witted. Minimum Value: 0 Maximum Value: 100
Assessment of Depression
Time frame: Participants are required to take 3-5 minutes to complete the BDI during recruitment process, baseline, and final visits. Through study completion, an average of 2 years.
Beck's depression inventory (BDI): the feeling of depression. During the recruitment process (screening process), potential participants who are having Beck's depression inventory score ≥21 will be excluded from this study. A higher score means a higher level of depression. Minimum Value: 0 Maximum Value: 63
Assessment of Stress
Time frame: During the baseline and final visits, participants are required to take 3-5 minutes to complete the PSS after NIH toolbox tests. Through study completion, an average of 2 years.
Perceived stress scale (PSS): the feeling of stress. A higher score means a higher level of stress. Minimum Value: 0 Maximum Value: 40
Sleep Assessment
Time frame: During the baseline and final visits, participants are required to take 3-5 minutes to complete the LSE after NIH toolbox tests. Through study completion, an average of 2 years.
Leeds sleep evaluation (LSE): sleep assessment. Participants will place marks on a group of 10-cm lines representing they have experienced in variety of symptoms of sleep. Lines extend between extremes like "more difficult than usual" and "easier than usual". Responses are measured using a 100-mm scale and are then averaged to provide a score for each domain. Theses can then be used to evaluate the efficacy and sleep-related side effects of juices.
Suicide Severity Assessment
Time frame: During the recruitment process, baseline, and final visits, participants are required to take 2 minutes to complete the CSSRS. Through study completion, an average of 2 years.
Columbia-Suicide Severity Rating Scale (CSSRS): suicide severity rating. During the recruitment process (screening process), potential participants who are having CSSRS (answer YES to actually having thoughts about killing yourself and thinking about you might do this) will be excluded from this study. Also, appropriate actions will be taken to ensure participants safety and well-being. For example, immediately contact a specified consultant and refer the participants who with high level of suicidality to the Crisis Hot Line. Suicidal assessments will also be assessed in V2 and V3 to ensure the participants do not have any suicidal tendencies. In sum, the assessment of suicidal should be completed immediately following the completion of the instruments.
Picture Vocabulary Test
Time frame: During the baseline and final visits, participants are required to take about 10-15 minutes to complete the Picture Vocabulary Test. Through study completion, an average of 2 years.
NIH Toolbox Picture Vocabulary Test: to assess participants' ability to understand and identify the meaning of words by matching them to corresponding images.
Flanker Inhibitory Control and Attention Test
Time frame: During the baseline and final visits, participants are required to take about 10-15 minutes to complete the Flanker Inhibitory Control and Attention Test. Through study completion, an average of 2 years.
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.
List Sorting Working Memory Test
Time frame: During the baseline and final visits, participants are required to take about 10-15 minutes to complete the List Sorting Working Memory Test. Through study completion, an average of 2 years.
NIH Toolbox List Sorting Working Memory Test: to assess participants' working memory abilities.
Dimensional Changes Card Sort Test
Time frame: During the baseline and final visits, participants are required to take about 10-15 minutes to complete the Dimensional Changes Card Sort Test. Through study completion, an average of 2 years.
NIH Toolbox Dimensional Changes Card Sort Test: to assess the cognitive flexibility of participants.
Pattern Comparison Processing Speed Test
Time frame: During the baseline and final visits, participants are required to take about 10-15 minutes to complete the Pattern Comparison Processing Speed Test. Through study completion, an average of 2 years.
NIH Toolbox Pattern Comparison Processing Speed Test: to assess the cognition processing speed of participants.
Picture Sequence Memory Test
Time frame: During the baseline and final visits, participants are required to take about 10-15 minutes to complete the Picture Sequence Memory Test. Through study completion, an average of 2 years.
NIH Toolbox Picture Sequence Memory Test: to assess participants' episodic memory.
Auditory Verbal Learning Test
Time frame: During the baseline and final visits, participants are required to take about 40-50 minutes to complete the Auditory Verbal Learning Test. Through study completion, an average of 2 years.
Auditory Verbal Learning Test: to assess participants' attention, memory, and learning ability in the auditory-verbal domain.
Fecal Content of Acetic acid, Propionic acid, and Butyric acid
Time frame: Participants are required to provide their fecal samples on the baseline and final visit. Through study completion, an average of 2 years. Through study completion, an average of 2 years.
Fecal content of acetic acid, propionic acid, and butyric acid will be determined using gas chromatography with a flame ionization detector.
Brain-derived neurotrophic factor (BDNF) Levels in Plasma
Time frame: A certified nurse will perform a blood draw for participants during both the baseline and final visits, using two tubes, resulting in a total of 20 mL. Through study completion, an average of 2 years.
BDNF levels in plasma will be measured using ELISA kit.
Neurotransmitters Analysis
Time frame: A certified nurse will perform a blood draw for participants during both the baseline and final visits, using two tubes, resulting in a total of 20 mL. Through study completion, an average of 2 years.
Monoamine oxidase (MAO) activity in plasma will be determined using the Amplex Red MAO Assay Kit.
1. Neurotransmitters Analysis
Time frame: A certified nurse will perform a blood draw for participants during both the baseline and final visits, using two tubes, resulting in a total of 20 mL. Through study completion, an average of 2 years.
Plasma levels of tryptophan metabolites (3-indole propionic acid, Indole-3-aldehyde , Serotonin, and Melatonin) will be quantified using the targeted metabolomic method.
2. Neurotransmitters Analysis
Time frame: A certified nurse will perform a blood draw for participants during both the baseline and final visits, using two tubes, resulting in a total of 20 mL. Through study completion, an average of 2 years.
Plasma levels of catecholamines (Dopamine, Epinephrine, and Norepinephrine) will be quantified using the targeted metabolomic method.
3. Neurotransmitters Analysis
Time frame: A certified nurse will perform a blood draw for participants during both the baseline and final visits, using two tubes, resulting in a total of 20 mL. Through study completion, an average of 2 years.
Plasma levels of histamine will be quantified using the targeted metabolomic method.
4. Neurotransmitters Analysis
Time frame: A certified nurse will perform a blood draw for participants during both the baseline and final visits, using two tubes, resulting in a total of 20 mL. Through study completion, an average of 2 years.
Plasma levels of Gamma-Aminobutyric acid (GABA) will be quantified using the targeted metabolomic method.
24-Hour Food Record
Time frame: During the baseline and final visits, participants are required to take about 10-15 minutes to complete the 24-Hour Food Record. Through study completion, an average of 2 years.
24-hour dietary record will be completed by participants using an Automated Self-Administered Dietary Assessment Tool.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
Related trials for Stress Response
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Active, not recruitingObservational study
The Developmental Origins of Suicide Mortality
Suicide Mortality
RecruitingPhase 4
Beta-Blocker Influences on Inflammatory and Neural Responses to Stress
Cardiovascular Disease
Active, not recruitingObservational study
Role of ROS and cAMP-PKA Biomarkers in ADPKD
Autosomal Dominant Polycystic Kidney Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberry Juice A and Cranberry Juice B in people with Stress Response and Multitasking Behavior, 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 20 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: paused, as of the sponsor's last update on 2 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (time frame: In baseline visit, for 15 minutes during multitasking; in final visit, for 15 minutes during multitasking. Through study completion, an average of 2 years.). The study lists 27 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 2 Jul 2026.