AttentionNCT05008549
A Study to Assess the Synergistic Effects of a Cranberry Beverage on Cognitive Function
A study testing Cranberry Juice Product in people with Attention and Mood, run by Ocean Spray Cranberries, Inc. at 1 site in United States.
Trial summary
This study aims to determine the effect short-term dosing (7 days) of a placebo beverage, cranberry juice, cranberry juice + lemon balm extract, cranberry juice + tart cherry powder, or cranberry juice + L-theanine or L-theanine beverage on cognitive function and mood in healthy adults (18-45 years). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Cranberry Juice Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2021to 1 Nov 2021
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be eligible for inclusion, the participant must fulfil all of the following criteria:
- Be able to give written informed consent and willing/able to comply with study procedures.
- Be between 18 and 45 years, inclusive.
- Is in general good health, as determined by the investigator.
- Has a BMI between ≥20 - ≤35 kg/m2.
- Has had a stable body weight (≤5 % change) over the past 3-months.
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- Has a Beck Depression Inventory II score ≤20 at screening.
- Willing to discontinue consumption of wine and dark red/blue colored fruits and polyphenol-rich fruits (e.g., pomegranate, blueberries, grapes), lemon balm, tart cherry powder, and L-Theanine for the two weeks leading up to the study (from the Screening visit V1 to baseline V2) and during the study.
- Willing and able to avoid consumption of any cranberry juice, whole cranberries, and dried cranberries for the two weeks leading up to the study (from the Screening visit V1 to baseline V2) and during the study, excluding the study beverage.
- Is willing to provide saliva samples.
- Maintain current level of physical activity and dietary habits throughout the study.
Who cannot join
- Participants that meet any of the following criteria will be excluded from the trial:
- Has a known or suspected allergy to components of the investigational product (e.g., cranberries, tart cherry, lemon balm, L-theanine).
- Uncontrolled blood pressure or untreated hypertension.
- Consumes >2 alcoholic beverages per day or >14 per week.
- Major chronic illness or health condition that might interfere with the study outcomes at the discretion of the study clinician or principal investigator.
- Use of antidepressant, anxiolytic, Central Nervous System stimulant, antipsychotic, antimanic, anti-inflammatory (except for aspirin and non-steroidal anti-inflammatory drugs [NSAIDS]. Multivitamins, vaccines, gender affirming hormones, HIV prevention medications, allergy medications, topical steroids are allowed for inclusion.)
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- Individuals who smoke or use nicotine patches or gum or e-cigarettes, or marijuana (within the past 6 months).
- Individuals who have experienced a stroke or a head injury with concussion, loss of consciousness or seizures.
- History or clinical manifestation of any significant neurologic disorder in the opinion of the investigator and/or study clinician.
- Any disease, that by the investigator's judgement, could interfere with the intestinal barrier function, including Celiac disease (Lactose intolerance or acid reflux are allowed for inclusion).
- Participants may not be receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial, these must have been completed not less than one month prior to this trial.
- Desire and/or plans on changing current diet and/or exercise regime during the participation of this trial.
- Individuals who are pregnant or lactating.
- Individuals currently of childbearing potential, but not using an effective method of contraception, as determined by the investigator.
- History of heavy caffeinated beverage consumption (>400 mg caffeine/day - or 4 cups of coffee per day) within past 2 weeks prior to the Screening Visit (V1), or before their Baseline Visit (V2).
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantia Clinical Trials Ltd
Chicago, Illinois, 60611
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled, Crossover Study, to Assess the Synergistic Effects of a Cranberry Beverage on Cognitive Function
This study aims to determine the effect short-term dosing (7 days) of a placebo beverage, cranberry juice, cranberry juice + lemon balm extract, cranberry juice + tart cherry powder, or cranberry juice + L-theanine or L-theanine beverage on cognitive function and mood in healthy adults (18-45 years). The study will include measures of attention, alertness, performance, and mood/stress.
Read the detailed description
1.1 Background information Berries from the Vaccinium genus have been reported to improve some measures of cognitive function in healthy adults. There is evidence that the polyphenols contained in berries and other plant foods may play a role in this regard. Among the plant sources of polyphenols, lemon balm and tart cherry reported to have positive effects on cognitive function in randomized controlled trials (RCTs).
L-theanine is an amino acid present almost exclusively in the tea plant (Camellia sinesis). L-theanine crosses the blood-brain barrier and has been shown to increase serotonin and dopamine production in rats. A recent systematic review of RCTs that evaluated the effect of supplemental L-theanine on stress concluded that L-theanine may assist in the reduction of stress.
Given that plant bioactives may have varying mechanisms to support cognitive health, the aim of this study is as follows:
Aim 1: To determine the effect short-term dosing (7 days) of a placebo beverage, cranberry juice, cranberry juice + lemon balm extract, cranberry juice + tart cherry powder, or cranberry juice + L-theanine or L-theanine beverage on cognitive function and mood in healthy adults (18-45 years). The study will include measures of attention, alertness, performance, and mood/stress.
1.2 Investigational product
Beverage to be tested:
- 100% cranberry juice (8 oz, Ocean Spray)
- 100% cranberry juice (8 oz) + lemon balm extract (300 mg)
- 100% cranberry juice (8 oz) + tart cherry powder (3 g)
- 100% cranberry juice (8 oz) + L-theanine (200 mg)
- L-theanine (200 mg) + placebo (matched for color, taste, calories)
- placebo (matched for color, taste, calories) 1.3 Rationale for conducting the clinical trial There is scientific support for Vaccinium berries to be of benefit to cognitive health. However, this has not be specifically tested in cranberries (Vaccinium macrocarpon). Furthermore, the individual effects of the other ingredients to be tested in this trial have been found to have positive effects on cognitive health but whether there are added effects with cranberry is not known. 2 OBJECTIVES 2.1 Primary objective To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on attention.
2.2 Primary endpoint variable
- Change in Accuracy of Attention composite scores outcomes from Baseline to each treatment phase (V3-8), assessed using the COMPASS cognitive assessment tool.
- Change in Speed of Attention composite scores outcomes from Baseline to each treatment phase (V3-8), assessed using the COMPASS cognitive assessment tool.
2.3 Secondary objectives To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on measures of focus, alertness, and cognition.
To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on mood and stress.
2.4 Secondary endpoint variables
- Focus: Change in Overall % accuracy scores outcomes from Baseline to each treatment phase (V3-8), assessed using the STROOP task in the COMPASS cognitive assessment tool.
- Alertness: Change in Alertness scores outcomes from Baseline to each treatment phase (V3-8), assessed using the self-rated Alertness VAS scale in the COMPASS cognitive assessment tool.
- Cognitive Performance:
- Change in Accuracy of Performance composite scores outcomes from Baseline to each treatment phase (V3-8), assessed using the COMPASS cognitive assessment tool.
- Change in Speed of Performance composite scores outcomes from Baseline to each treatment phase (V3-8), assessed using the COMPASS cognitive assessment tool.
- Mood: Change in Total Mood Disturbance scores from Baseline to each subsequent visit (V3-8), assessed using the Profile of Mood States-Short Questionnaire.
- Stress: Change in salivary cortisol from Baseline to each treatment phase (V3-8).
2.5 Exploratory objectives Dependent upon the outcome of the Primary and Secondary objectives, additional outcomes from the COMPASS cognitive assessment tool may be analyzed further to assess the impact of the investigational product on various domains of cognition.
- Being tested
- Cranberry Juice Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry Juice ProductDietary supplement
Also called Cranberry Juice + Lemon Balm Extract Product, Cranberry Juice + Tart Cherry Juice Product, Cranberry Juice + L-theanine Product, L-theanine + Placebo Product
The cranberry juice product contains 100 % cranberry juice (ingredients: water, cranberry juice concentrate)
The cranberry juice + lemon balm extract product contains 100 % cranberry juice (ingredients: water, cranberry juice concentrate) + lemon balm extract (300 mg, Robertet Groupe)
The cranberry juice + tart cherry juice product contains 100 % cranberry juice (ingredients: water, cranberry juice concentrate) + 3 g tart cherry powder (Cherry PURE)
The cranberry juice + L-theanine product contains 100% cranberry juice (ingredients: water, cranberry juice concentrate) + 200 mg L-theanine (Suntheanine, Taiyo International)
L-theanine + placebo product contains L-theanine (200 mg, Suntheanine, Taiyo International) + placebo (see 5.2.1)
The placebo product contains water, dextrose, citric acid, malic acid, fumaric acid, natural flavor, Red #40, xanthan gum, Blue #1, gum Arabic, Reb M, Steviol glycosides, and ester gum.
| Study group | Role | What they receive |
|---|---|---|
| First Product Order: order not stated to protect study blinding | Experimental | Participants will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for 7 days, followed by a 7 day wash-out period before beginning the next product in the sequence. Receives: Dietary Supplement: Cranberry Juice Product |
| Second Product Order: order not stated to protect study blinding | Experimental | Participants will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for 7 days, followed by a 7 day wash-out period before beginning the next product in the sequence Receives: Dietary Supplement: Cranberry Juice Product |
| Third Product Order: order not stated to protect study blinding | Experimental | Participants will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for 7 days, followed by a 7 day wash-out period before beginning the next product in the sequence Receives: Dietary Supplement: Cranberry Juice Product |
| Fourth Product Order: order not stated to protect study blinding | Experimental | Participants will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for 7 days, followed by a 7 day wash-out period before beginning the next product in the sequence Receives: Dietary Supplement: Cranberry Juice Product |
| Fifth Product Order: order not stated to protect study blinding | Experimental | Participants will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for 7 days, followed by a 7 day wash-out period before beginning the next product in the sequence Receives: Dietary Supplement: Cranberry Juice Product |
| Sixth Product Order: order not stated to protect study blinding | Experimental | Participants will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for 7 days, followed by a 7 day wash-out period before beginning the next product in the sequence Receives: Dietary Supplement: Cranberry Juice Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on attention.
Change in Accuracy of Attention and Change in Speed of Attention composite scores outcomes from Baseline to each treatment phase (V3-8), assessed using the COMPASS cognitive assessment tool.
Measured: 7 days
Secondary outcomes (6)
To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on measures of focus.
Change in Overall % accuracy scores outcomes from Baseline to each treatment phase (V3-8), assessed using the STROOP task in the COMPASS cognitive assessment tool.
Measured: 7 days
To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on measures of alertness.
Change in Alertness scores outcomes from Baseline to each treatment phase (V3-8), assessed using the self-rated Alertness Visual Analogue Scale in the COMPASS cognitive assessment tool.
Measured: 7 days
To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on measures of cognition (accuracy of performance).
Change in Accuracy of Performance composite scores outcomes from Baseline to each treatment phase (V3-8), assessed using the COMPASS cognitive assessment tool.
Measured: 7 days
To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on measures of cognition (speed of performance).
Change in Speed of Performance composite scores outcomes from Baseline to each treatment phase (V3-8), assessed using the COMPASS cognitive assessment tool.
Measured: 7 days
To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on mood.
Change in Total Mood Disturbance scores from Baseline to each subsequent visit (V3-8), assessed using the Profile of Mood States-Short Questionnaire.
Measured: 7 days
To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on stress.
Change in salivary cortisol from Baseline to each treatment phase (V3-8).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start26 Jul 2021
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AttentionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, double-blinded, placebo-controlled, crossover study, to assess the synergistic effects of a cranberry beverage on cognitive function in healthy adults aged 18-45.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocean Spray Cranberries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Alice Eggleston, PA-C, MPH, Principal investigator, Atlantia Clinical Trials Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008549
- Sponsor's protocol ID
- AFCRO-140
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2021
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Travica N, D'Cunha NM, Naumovski N, Kent K, Mellor DD, Firth J, Georgousopoulou EN, Dean OM, Loughman A, Jacka F, Marx W. The effect of blueberry interventions on cognitive performance and mood: A systematic review of randomized controlled trials. Brain Behav Immun. 2020 Mar;85:96-105. doi: 10.1016/j.bbi.2019.04.001. Epub 2019 Apr 15.
PubMed 30999017Lamport DJ, Williams CM. Polyphenols and Cognition In Humans: An Overview of Current Evidence from Recent Systematic Reviews and Meta-Analyses. Brain Plast. 2021 Feb 9;6(2):139-153. doi: 10.3233/BPL-200111.
PubMed 33782647Scholey A, Gibbs A, Neale C, Perry N, Ossoukhova A, Bilog V, Kras M, Scholz C, Sass M, Buchwald-Werner S. Anti-stress effects of lemon balm-containing foods. Nutrients. 2014 Oct 30;6(11):4805-21. doi: 10.3390/nu6114805.
PubMed 25360512Kennedy DO, Scholey AB, Tildesley NT, Perry EK, Wesnes KA. Modulation of mood and cognitive performance following acute administration of Melissa officinalis (lemon balm). Pharmacol Biochem Behav. 2002 Jul;72(4):953-64. doi: 10.1016/s0091-3057(02)00777-3.
PubMed 12062586Kennedy DO, Little W, Scholey AB. Attenuation of laboratory-induced stress in humans after acute administration of Melissa officinalis (Lemon Balm). Psychosom Med. 2004 Jul-Aug;66(4):607-13. doi: 10.1097/01.psy.0000132877.72833.71.
PubMed 15272110Chai SC, Jerusik J, Davis K, Wright RS, Zhang Z. Effect of Montmorency tart cherry juice on cognitive performance in older adults: a randomized controlled trial. Food Funct. 2019 Jul 17;10(7):4423-4431. doi: 10.1039/c9fo00913b.
PubMed 31287117Yokogoshi H, Kobayashi M, Mochizuki M, Terashima T. Effect of theanine, r-glutamylethylamide, on brain monoamines and striatal dopamine release in conscious rats. Neurochem Res. 1998 May;23(5):667-73. doi: 10.1023/a:1022490806093.
PubMed 9566605Williams JL, Everett JM, D'Cunha NM, Sergi D, Georgousopoulou EN, Keegan RJ, McKune AJ, Mellor DD, Anstice N, Naumovski N. The Effects of Green Tea Amino Acid L-Theanine Consumption on the Ability to Manage Stress and Anxiety Levels: a Systematic Review. Plant Foods Hum Nutr. 2020 Mar;75(1):12-23. doi: 10.1007/s11130-019-00771-5.
PubMed 31758301
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled, Crossover Study, to Assess the Synergistic Effects of a Cranberry Beverage on Cognitive Function
- ClinicalTrials.gov ID
- NCT05008549
- Acronym / sponsor ID
- AFCRO-140
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ocean Spray Cranberries, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 17 Aug 2021 (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 study aims to determine the effect short-term dosing (7 days) of a placebo beverage, cranberry juice, cranberry juice + lemon balm extract, cranberry juice + tart cherry powder, or cranberry juice + L-theanine or L-theanine beverage on cognitive function and mood in healthy adults (18-45 years). The study will include measures of attention, alertness, performance, and mood/stress.
Detailed description
1.1 Background information Berries from the Vaccinium genus have been reported to improve some measures of cognitive function in healthy adults. There is evidence that the polyphenols contained in berries and other plant foods may play a role in this regard. Among the plant sources of polyphenols, lemon balm and tart cherry reported to have positive effects on cognitive function in randomized controlled trials (RCTs).
L-theanine is an amino acid present almost exclusively in the tea plant (Camellia sinesis). L-theanine crosses the blood-brain barrier and has been shown to increase serotonin and dopamine production in rats. A recent systematic review of RCTs that evaluated the effect of supplemental L-theanine on stress concluded that L-theanine may assist in the reduction of stress.
Given that plant bioactives may have varying mechanisms to support cognitive health, the aim of this study is as follows:
Aim 1: To determine the effect short-term dosing (7 days) of a placebo beverage, cranberry juice, cranberry juice + lemon balm extract, cranberry juice + tart cherry powder, or cranberry juice + L-theanine or L-theanine beverage on cognitive function and mood in healthy adults (18-45 years). The study will include measures of attention, alertness, performance, and mood/stress.
1.2 Investigational product
Beverage to be tested:
- 100% cranberry juice (8 oz, Ocean Spray)
- 100% cranberry juice (8 oz) + lemon balm extract (300 mg)
- 100% cranberry juice (8 oz) + tart cherry powder (3 g)
- 100% cranberry juice (8 oz) + L-theanine (200 mg)
- L-theanine (200 mg) + placebo (matched for color, taste, calories)
- placebo (matched for color, taste, calories) 1.3 Rationale for conducting the clinical trial There is scientific support for Vaccinium berries to be of benefit to cognitive health. However, this has not be specifically tested in cranberries (Vaccinium macrocarpon). Furthermore, the individual effects of the other ingredients to be tested in this trial have been found to have positive effects on cognitive health but whether there are added effects with cranberry is not known. 2 OBJECTIVES 2.1 Primary objective To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on attention.
2.2 Primary endpoint variable
- Change in Accuracy of Attention composite scores outcomes from Baseline to each treatment phase (V3-8), assessed using the COMPASS cognitive assessment tool.
- Change in Speed of Attention composite scores outcomes from Baseline to each treatment phase (V3-8), assessed using the COMPASS cognitive assessment tool.
2.3 Secondary objectives To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on measures of focus, alertness, and cognition.
To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on mood and stress.
2.4 Secondary endpoint variables
- Focus: Change in Overall % accuracy scores outcomes from Baseline to each treatment phase (V3-8), assessed using the STROOP task in the COMPASS cognitive assessment tool.
- Alertness: Change in Alertness scores outcomes from Baseline to each treatment phase (V3-8), assessed using the self-rated Alertness VAS scale in the COMPASS cognitive assessment tool.
- Cognitive Performance:
- Change in Accuracy of Performance composite scores outcomes from Baseline to each treatment phase (V3-8), assessed using the COMPASS cognitive assessment tool.
- Change in Speed of Performance composite scores outcomes from Baseline to each treatment phase (V3-8), assessed using the COMPASS cognitive assessment tool.
- Mood: Change in Total Mood Disturbance scores from Baseline to each subsequent visit (V3-8), assessed using the Profile of Mood States-Short Questionnaire.
- Stress: Change in salivary cortisol from Baseline to each treatment phase (V3-8).
2.5 Exploratory objectives Dependent upon the outcome of the Primary and Secondary objectives, additional outcomes from the COMPASS cognitive assessment tool may be analyzed further to assess the impact of the investigational product on various domains of cognition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- Model description
- A randomized, double-blinded, placebo-controlled, crossover study, to assess the synergistic effects of a cranberry beverage on cognitive function in healthy adults aged 18-45.
| Arm | Type | Receives |
|---|---|---|
| First Product Order: order not stated to protect study blinding | Experimental | Dietary Supplement: Cranberry Juice ProductParticipants will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for 7 days, followed by a 7 day wash-out period before beginning the next product in the sequence. |
| Second Product Order: order not stated to protect study blinding | Experimental | Dietary Supplement: Cranberry Juice ProductParticipants will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for 7 days, followed by a 7 day wash-out period before beginning the next product in the sequence |
| Third Product Order: order not stated to protect study blinding | Experimental | Dietary Supplement: Cranberry Juice ProductParticipants will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for 7 days, followed by a 7 day wash-out period before beginning the next product in the sequence |
| Fourth Product Order: order not stated to protect study blinding | Experimental | Dietary Supplement: Cranberry Juice ProductParticipants will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for 7 days, followed by a 7 day wash-out period before beginning the next product in the sequence |
| Fifth Product Order: order not stated to protect study blinding | Experimental | Dietary Supplement: Cranberry Juice ProductParticipants will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for 7 days, followed by a 7 day wash-out period before beginning the next product in the sequence |
| Sixth Product Order: order not stated to protect study blinding | Experimental | Dietary Supplement: Cranberry Juice ProductParticipants will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for 7 days, followed by a 7 day wash-out period before beginning the next product in the sequence |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Be able to give written informed consent and willing/able to comply with study procedures.
- Be between 18 and 45 years, inclusive.
- Is in general good health, as determined by the investigator.
- Has a BMI between ≥20 - ≤35 kg/m2.
- Has had a stable body weight (≤5 % change) over the past 3-months.
Key exclusion criteria (15 listed)
- Has a known or suspected allergy to components of the investigational product (e.g., cranberries, tart cherry, lemon balm, L-theanine).
- Uncontrolled blood pressure or untreated hypertension.
- Consumes >2 alcoholic beverages per day or >14 per week.
- Major chronic illness or health condition that might interfere with the study outcomes at the discretion of the study clinician or principal investigator.
- Use of antidepressant, anxiolytic, Central Nervous System stimulant, antipsychotic, antimanic, anti-inflammatory (except for aspirin and non-steroidal anti-inflammatory drugs [NSAIDS]. Multivitamins, vaccines, gender affirming hormones, HIV prevention medications, allergy medications, topical steroids are allowed for inclusion.)
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 ProductAlso: Cranberry Juice + Lemon Balm Extract Product, Cranberry Juice + Tart Cherry Juice Product, Cranberry Juice + L-theanine Product, L-theanine + Placebo ProductThe cranberry juice product contains 100 % cranberry juice (ingredients: water, cranberry juice concentrate) The cranberry juice + lemon balm extract product contains 100 % cranberry juice (ingredients: water, cranberry juice concentrate) + lemon balm extract (300 mg, Robertet Groupe) The cranberry juice + tart cherry juice product contains 100 % cranberry juice (ingredients: water, cranberry juice concentrate) + 3 g tart cherry powder (Cherry PURE) The cranberry juice + L-theanine product contains 100% cranberry juice (ingredients: water, cranberry juice concentrate) + 200 mg L-theanine (Suntheanine, Taiyo International) L-theanine + placebo product contains L-theanine (200 mg, Suntheanine, Taiyo International) + placebo (see 5.2.1) The placebo product contains water, dextrose, citric acid, malic acid, fumaric acid, natural flavor, Red #40, xanthan gum, Blue #1, gum Arabic, Reb M, Steviol glycosides, and ester gum. | Dietary supplement | Fifth Product Order: order not stated to protect study blinding, First Product Order: order not stated to protect study blinding, Fourth Product Order: order not stated to protect study blinding, Second Product Order: order not stated to protect study blinding, Sixth Product Order: order not stated to protect study blinding, Third Product Order: order not stated to protect study blinding |
Primary outcome
To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on attention.
Time frame: 7 days
Change in Accuracy of Attention and Change in Speed of Attention composite scores outcomes from Baseline to each treatment phase (V3-8), assessed using the COMPASS cognitive assessment tool.
6 secondary outcomes
To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on measures of focus.
Time frame: 7 days
To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on measures of alertness.
Time frame: 7 days
To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on measures of cognition (accuracy of performance).
Time frame: 7 days
To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on measures of cognition (speed of performance).
Time frame: 7 days
To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on mood.
Time frame: 7 days
To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on stress.
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Results publication: PubMed 30999017Travica N, D'Cunha NM, Naumovski N, Kent K, Mellor DD, Firth J, Georgousopoulou EN, Dean OM, Loughman A, Jacka F, Marx W. The effect of blueberry interventions on cognitive performance and mood: A systematic review of randomized controlled trials. Brain Behav Immun. 2020 Mar;85:96-105. doi: 10.1016/j.bbi.2019.04.001. Epub 2019 Apr 15.
- Results publication: PubMed 33782647Lamport DJ, Williams CM. Polyphenols and Cognition In Humans: An Overview of Current Evidence from Recent Systematic Reviews and Meta-Analyses. Brain Plast. 2021 Feb 9;6(2):139-153. doi: 10.3233/BPL-200111.
- Results publication: PubMed 25360512Scholey A, Gibbs A, Neale C, Perry N, Ossoukhova A, Bilog V, Kras M, Scholz C, Sass M, Buchwald-Werner S. Anti-stress effects of lemon balm-containing foods. Nutrients. 2014 Oct 30;6(11):4805-21. doi: 10.3390/nu6114805.
- Results publication: PubMed 12062586Kennedy DO, Scholey AB, Tildesley NT, Perry EK, Wesnes KA. Modulation of mood and cognitive performance following acute administration of Melissa officinalis (lemon balm). Pharmacol Biochem Behav. 2002 Jul;72(4):953-64. doi: 10.1016/s0091-3057(02)00777-3.
- Results publication: PubMed 15272110Kennedy DO, Little W, Scholey AB. Attenuation of laboratory-induced stress in humans after acute administration of Melissa officinalis (Lemon Balm). Psychosom Med. 2004 Jul-Aug;66(4):607-13. doi: 10.1097/01.psy.0000132877.72833.71.
- Results publication: PubMed 31287117Chai SC, Jerusik J, Davis K, Wright RS, Zhang Z. Effect of Montmorency tart cherry juice on cognitive performance in older adults: a randomized controlled trial. Food Funct. 2019 Jul 17;10(7):4423-4431. doi: 10.1039/c9fo00913b.
- Results publication: PubMed 9566605Yokogoshi H, Kobayashi M, Mochizuki M, Terashima T. Effect of theanine, r-glutamylethylamide, on brain monoamines and striatal dopamine release in conscious rats. Neurochem Res. 1998 May;23(5):667-73. doi: 10.1023/a:1022490806093.
- Results publication: PubMed 31758301Williams JL, Everett JM, D'Cunha NM, Sergi D, Georgousopoulou EN, Keegan RJ, McKune AJ, Mellor DD, Anstice N, Naumovski N. The Effects of Green Tea Amino Acid L-Theanine Consumption on the Ability to Manage Stress and Anxiety Levels: a Systematic Review. Plant Foods Hum Nutr. 2020 Mar;75(1):12-23. doi: 10.1007/s11130-019-00771-5.
- Individual participant dataSharing planned: No
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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.
Alice Eggleston, PA-C, MPH principal investigator
Atlantia Clinical Trials Ltd.
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 Product in people with Attention and Mood, run by Ocean Spray Cranberries, Inc. 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 11 inclusion and 15 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: finished, as of the sponsor's last update on 7 Jul 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on attention. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05008549, which also lists 8 linked publications.
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 7 Jul 2023.