NCT05182450已完成不适用
Acute Effects of Mango Leaf Extract on Cognitive Function in Healthy Adults: A Double-Blind, Placebo-Controlled Crossover Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Accuracy of attention
研究概览
简要总结
The primary aim of this randomised, double-blind, placebo-controlled, cross-over study is to assess the short-term cognitive effects of a single dose (300 mg) of Mango Leaf Extract compared to a placebo on cognitive function, including during cognitively demanding task performance. The trial will utilise the COMPASS cognitive assessment system and cognitive demand battery (CDB), and Profile of Mood States (POMS), visual analogue mood scales (VAMS), and Stress Visual Analogue Scales (S-VAS) with assessments taking place at baseline, 30 minutes, 180 minutes and 300 minutes post treatment, on two separate testing days separated by 7 days (minimum).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Capsules will disguise potential differences in colour/particle size of powders
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
- •Participants aged 18 to 45 years, inclusive
- •Self-reported good health
- •Willingness to abstain from consumption of caffeine within 12 h of testing
- •Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits
- •Willing to refrain from 'over the counter' medications (e.g., pain medication) and stimulant medication for 12 hours, seasonal allergy/hayfever nasal antihistamine medications for 24 hours and oral antihistamines for 48 hours prior to all test visits
- •Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator
排除标准
- •Failure to meet any one of the inclusion criteria
- •Have any pre-existing medical condition/illness which will impact taking part in the study, interact with the active treatments or impede performance
- •Current use of prescription medication (no antibiotics within the last 4 weeks) NOTE: the explicit exceptions to this are contraceptive treatments for female participants, and those taken 'as needed' in the treatment of asthma and hay fever. There may be other instances of medication use which, where no interaction with the active treatments is likely, and which would not be expected to have any impact on brain function, where participants may be able to progress to screening
- •Have sleep disorders or are taking sleep aid medication
- •Major trauma or major surgical event within 6 months of screening
- •Extreme dietary habits, as judged by the Investigator (high fat, very high protein diets, intermittent fasting, etc.)
- •Exposure to mango leaf extract (MLE) within 30 d prior to screening
- •History of cancer in the prior two years, except for non-melanoma skin cancer
- •Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour blindness)
- •Food allergies/intolerances/sensitivities to any ingredients in the study products and study meals (including related foods/beverages/products) and or unwillingness to eat or dislike for the study meals.
- •Self-report excessive leisure time physical activity (> 7 strenuous bouts per week)
- •Have a current or chronic gastrointestinal, sleep, or psychiatric disorders including medically diagnosed anxiety and depression
- •Work night shifts or follow a variable work pattern that results in irregular sleep pattern
- •Are pregnant, trying to get pregnant or lactating
- •Smoke tobacco, vape nicotine or use nicotine replacement products (including occasional social smoking)
- •Illegal/recreational drug use
- •Fail to demonstrate adequate minimal performance on lab, computer-based cognitive tasks
- •Have participated in another clinical trial within past 30 days and/or participation in another PepsiCo trial in the past 6 months
- •Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
- •Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2
- •Have a diagnosed neurological condition, or learning/behavioural or neurodevelopmental differences (e.g. dyslexia, autism, ADHD).
- •Excessive caffeine intake (>500 mg per day)
- •Have taken dietary supplements e.g. Vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4-week supplement washout prior to participating and for the duration of the study on the proviso that the supplements taken are out of choice and not medically prescribed or advised)
- •Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
- •Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
- •Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months
- •Suffers from frequent migraines that require medication (more than or equal to 1 per month)
- •Any known active infections
- •Are non-compliant with regards treatment consumption
- •Does not have a bank account (required for payment)
研究组 & 干预措施
Active capsule
Experimental
Colored capsule containing 300 mg mango leaf extract (Zynamite®) standardized to contain ≥ 60% mangiferin. Supplied by PLT Health Solutions, Inc.
干预措施: Mango leaf extract capsule (Other)
Placebo capsule
Placebo Comparator
Colored capsule, appearance-matched to the active experimental capsule
干预措施: Placebo capsule (Other)
结局指标
主要结局
Accuracy of attention
时间窗: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Average % correct of attention tasks - choice reaction time, digit vigilance and 3 x rapid visual information processing task). Higher accuracy is better.
次要结局
- Cognitive performance: Episodic long term memory(Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo)
- Global cognitive performance measures: Speed(Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo)
- Cognitive performance: Working memory(Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo)
- General mood and psychological state, including depression and anxiety: VAMS(Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo)
- General mood and psychological state, including depression and anxiety: POMS(Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo)
- General mood and psychological state, including depression and anxiety: S-VAS(Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo)
- Cognitive performance: Attention(Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo)
- Cognitive domain factor scores(Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo)
- Global cognitive performance measures: Accuracy(Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo)
- Cognitive performance: Executive function(Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo)
- Cognitive function and mental fatigue during extended performance of cognitively demanding tasks(30, 180 and 300 minutes post-dose compared to placebo)
研究者
研究点 (1)
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