A Randomized, Double-blinded, Placebo-controlled, Crossover Study, to Assess the Synergistic Effects of a Cranberry Beverage on Cognitive Function

Ocean Spray Cranberries, Inc.1 个研究点分布在 1 个国家目标入组 25 人开始时间: 2021年7月26日最近更新: 2023年7月7日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Ocean Spray Cranberries, Inc.
入组人数: 25
试验地点: 1
主要终点: To evaluate in healthy adults the effect of 7-day consumption of cranberry beverages compared to placebo on attention.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Other
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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/m
•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.

排除标准

•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).

研究组 & 干预措施

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.