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Search / Trial NCT05008549

A Study to Assess the Synergistic Effects of a Cranberry Beverage on Cognitive Function

Launched by OCEAN SPRAY CRANBERRIES, INC. · Aug 9, 2021

Trial Information

Current as of July 21, 2025

Completed

Keywords

ClinConnect Summary

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 serotoni...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • To be eligible for inclusion, the participant must fulfil all of the following criteria:
  • 1. Be able to give written informed consent and willing/able to comply with study procedures.
  • 2. Be between 18 and 45 years, inclusive.
  • 3. Is in general good health, as determined by the investigator.
  • 4. Has a BMI between ≥20 - ≤35 kg/m2.
  • 5. Has had a stable body weight (≤5 % change) over the past 3-months.
  • 6. Has a Beck Depression Inventory II score ≤20 at screening.
  • 7. 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.
  • 8. 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.
  • 9. Is willing to provide saliva samples.
  • 10. Maintain current level of physical activity and dietary habits throughout the study.
  • Exclusion Criteria:
  • Participants that meet any of the following criteria will be excluded from the trial:
  • 1. Has a known or suspected allergy to components of the investigational product (e.g., cranberries, tart cherry, lemon balm, L-theanine).
  • 2. Uncontrolled blood pressure or untreated hypertension.
  • 3. Consumes \>2 alcoholic beverages per day or \>14 per week.
  • 4. Major chronic illness or health condition that might interfere with the study outcomes at the discretion of the study clinician or principal investigator.
  • 5. 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.)
  • 6. Individuals who smoke or use nicotine patches or gum or e-cigarettes, or marijuana (within the past 6 months).
  • 7. Individuals who have experienced a stroke or a head injury with concussion, loss of consciousness or seizures.
  • 8. History or clinical manifestation of any significant neurologic disorder in the opinion of the investigator and/or study clinician.
  • 9. 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).
  • 10. 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.
  • 11. Desire and/or plans on changing current diet and/or exercise regime during the participation of this trial.
  • 12. Individuals who are pregnant or lactating.
  • 13. Individuals currently of childbearing potential, but not using an effective method of contraception, as determined by the investigator.
  • 14. 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).

About Ocean Spray Cranberries, Inc.

Ocean Spray Cranberries, Inc. is a renowned agricultural cooperative and leading producer of cranberry-based products, dedicated to promoting health and wellness through innovative research and development. With a commitment to quality and sustainability, the company harnesses the nutritional benefits of cranberries to create a diverse range of functional foods and beverages. Ocean Spray actively engages in clinical trials to explore the health properties of its products, aiming to advance scientific understanding and validate the positive effects of cranberries on human health. Through collaboration with research institutions and healthcare professionals, Ocean Spray strives to contribute valuable insights to the field of nutrition and functional ingredients.

Locations

Chicago, Illinois, United States

Patients applied

0 patients applied

Trial Officials

Alice Eggleston, PA-C, MPH

Principal Investigator

Atlantia Clinical Trials Ltd.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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