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

Completed · Not applicable · Has a placebo group

Conditions studied: Attention, Mood

In brief

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.

Key facts

Study ID

NCT05008549

Run by

Ocean Spray Cranberries, Inc.

People needed

25

Starts

2021-07-26

Expected to finish

2021-11-01

Last updated by the study team

2023-07-07

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.)
• 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).

Where it is running

• Atlantia Clinical Trials Ltd — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.