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

NCT05008549 | Completed

• 1 other identifier: AFCRO-140
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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). The study will include measures of attention, alertness, performance, and mood/stress.

Conditions

Attention; Mood

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  7 days

• To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on measures of alertness.

  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).

  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).

  7 days

• To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on mood.

  7 days

Other Outcomes (6)

• To evaluate in healthy adults the safety and tolerability of 7-day consumption of cranberry beverages compared to placebo (Proportion of Adverse Events).

  7 days

• To evaluate in healthy adults the safety and tolerability of 7-day consumption of cranberry beverages compared to placebo (Incidence of Adverse Events).

  7 days

• To evaluate in healthy adults the safety and tolerability of 7-day consumption of cranberry beverages compared to placebo (Incidence of Serious Adverse Events).

  7 days

Study Arms (6)

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.

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

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

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

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

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

Dietary Supplement: Cranberry Juice Product

Interventions

Cranberry Juice Product DIETARY_SUPPLEMENT

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.

Also known as: Cranberry Juice + Lemon Balm Extract Product, Cranberry Juice + Tart Cherry Juice Product, Cranberry Juice + L-theanine Product, L-theanine + Placebo Product, Placebo Product

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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).

Sponsors & Collaborators

• Ocean Spray Cranberries, Inc.: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Clinical Trials Ltd

Chicago, Illinois, 60611, United States

Location

Related Publications (8)

• 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.

  PMID: 30999017 RESULT

• Lamport 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.

  PMID: 33782647 RESULT

• Scholey 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.

  PMID: 25360512 RESULT

• Kennedy 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.

  PMID: 12062586 RESULT

• Kennedy 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.

  PMID: 15272110 RESULT

• Chai 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.

  PMID: 31287117 RESULT

• Yokogoshi 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.

  PMID: 9566605 RESULT

• Williams 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.

  PMID: 31758301 RESULT

MeSH Terms

Interventions

theanine

Study Officials

• Alice Eggleston, PA-C, MPH

  Atlantia Clinical Trials Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 17, 2021
• Study Start: July 26, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)