A Study to Assess the Synergistic Effects of a Cranberry Beverage on Cognitive Function
Condition: Attention; Mood
Study type: Interventional

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.
    

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.
    

Intervention name(s): Cranberry Juice Product
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Other intervention name(s): Cranberry Juice + Lemon Balm Extract Product; Cranberry Juice + Tart Cherry Juice Product; Cranberry Juice + L-theanine Product; L-theanine + Placebo Product; Placebo Product
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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 (Participant, Care Provider, Investigator)
Primary purpose: Other