A Double Blind Randomised Clinical Study to Evaluate Attention Improvement in an Adult Population After Cereboost Intake
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Measure of Attention
研究概览
简要总结
The study will assess the immediate, short-term benefits of a single dose of a supplement containing 200mg of Panax quinquefolius (American Ginseng) on cognition (brain function) in healthy young adults.
To understand the effect this product may have, the participants will complete a series of questionnaires and cognitive tests (tests of memory and brain function) at set intervals across a 6-hour period. Blood samples will also be collected to assess the impact of the study product on the participants.
详细描述
Lifestyle strategies such as nutritional interventions have received increased attention as they provide safe and effective solutions to improve cognitive performance. Ginseng, a popular herbal root extract obtained from plants of the Panax family, is widely regarded as a panacea in traditional medicine and has been used for centuries to treat mental and physical ailments and promote longevity. Ginseng contains a number of bioactives including flavonoids and other phenolic compounds, essential oils, and vitamins. However, the main bioactive ingredients in ginseng are purported to be ginsenosides including Rb1, Re, Rd, and F11. Among multiple species of ginseng, American ginseng (Panax quinquefolius) provides a particularly rich source of these ginsenoside when compared to other ginseng varieties, and emerging research suggests that supplementation with Panax quinquefolius may elicit cognitive enhancement effects.
Cereboost TM from Givaudan SA is a standardised extract of American ginseng and has been reported to exert such benefits. For example, following acute supplementation with 100 mg, 200 mg and 400 mg Cereboost TM, improvements on an immediate word recall task, a visuospatial working memory task, a choice reaction time task, a composite working memory factor, and a measure of subjective mood (i.e. calmness) were observed in healthy young adults (aged 18-40 years) during the six hours after consumption. Adding to these findings, a study of middle-aged adults (aged 40-60 years) observed similar acute benefits of 200 mg Cereboost TM on a composite working memory factor after three hours, although no changes in mood were observed in this older age group. More recently, improved working memory and attention during the immediate postprandial period (2-6 hours) in healthy young adults was reported following Cereboost TM 200mg intake.
We are interested in conducting a larger study (n=200) employing standardised methods to investigate the acute benefits of a single dose (200mg) of American ginseng (Cereboost TM) and focusing mainly on the Modified Attention Network Task (MANT) test as the primary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 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 the following criteria:
- •Be able to give written informed consent.
- •Be between 18-40 years, inclusive.
- •Depression Anxiety and Stress Scale scores (DASS-21):
- •Depression ≤9
- •Willing to refrain from alcohol consumption 24-hours prior to assessment visits.
- •Willing to refrain from caffeine consumption (including but not limited to energy drinks, soda, coffee…) on the morning of the assessment visit.
- •Non-smokers and non-vapers
- •Willing to consume the Study Product (SP).
- •Willing to attend the study visit in an overnight fasted state, having followed a low-polyphenol diet for 48 h.
- •Fluent in written and spoken English
排除标准
- •Participants will be excluded from the study if they meet any of the following criteria:
- •Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
- •Has food allergies or other issues with foods that would preclude intake of the Study Products.
- •Not willing to consume gelatine from bovine/porcine source
- •Has a BMI ≤18.5 or ≥30kg/m2
- •Blood pressure >140/90 mmHg
- •Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results.
- •Excluded health conditions include:
- •Cognitive disorders in the past 12 months.
- •Current or past history of a major neuropsychiatric disorder, including: bipolar disorder, schizophrenia and schizotypal personality disorder
- •Current or past history of a major neurological condition.
- •Gastrointestinal disorders (e.g. IBS/IBD)
- •ADHD (attention deficit hyperactivity disorder)
- •Learning disabilities and difficulties
- •Current, uncorrected, vision or hearing impairment
- •Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
- •Anti-psychotics
- •Anti-coagulants (including Warfarin)
- •Anti-platelets (including Aspirin and Clopidogrel)
- •Monoamine Oxidase Inhibitors (MAOIs)
- •Taking any dietary supplements and unwilling to stop for two weeks prior to and for the duration of participation in the study
- •Current or history of drug or alcohol abuse
- •Current or history of: HIV, kidney disease, liver or biliary disorders, cancer, cardiovascular disease, pulmonary disease (chronic respiratory trouble)
- •Planned surgery within 2 weeks of their participation in the study
- •Do not agree to the GP being contacted about participation and screening results
- •Participated in any other cognitive trials within the last month
研究组 & 干预措施
Placebo
A placebo capsule (containing maltodextrin)
干预措施: Placebo product (Dietary Supplement)
Study Product
Study product capsule containing 200mg American Ginseng extract (Cereboost TM)
干预措施: American Ginseng extract (Dietary Supplement)
结局指标
主要结局
Measure of Attention
时间窗: Baseline, 2-hours, 4-hours and 6-hours post intervention
Measured by the Attentional Network Task (ANT), expressed by accuracy score (%correct) at 6 hours post consumption
次要结局
- Measure of Mood State(At the beginning and end of the cognitive task batteries at baseline, and at 2-hours, 4-hours and 6-hours post intervention)
- Measure of Subjective Sleepiness(At the beginning and end of the cognitive task batteries at baseline, and at 2-hours, 4-hours and 6-hours post intervention)
- Measure of Subjective Mental Fatigue(At the beginning and end of the cognitive task batteries at baseline, and at 2-hours, 4-hours and 6-hours post intervention)
- Measure of American Ginseng metabolites(Blood collection at 6-hours post intervention timepoint)
- Measure of Cognition (Executive function)(Baseline, 2-hours, 4-hours and 6-hours post intervention)
- Measure of Cognition (Reaction Time)(Baseline, 2-hours, 4-hours and 6-hours post intervention)