Confirmatory Study on the Acute Effects of Zynamite® S on Cognitive Function and Mood in University Students: a Randomized, Double-blind, Placebo-controlled Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Changes in Trail Making Test (TMT) Score
研究概览
简要总结
The present study sought to confirm the cognitive and mood benefits of a standardized soluble mango leaf extract, named as Zynamite® S. A placebo or a single dose of the botanical extract (100 mg) was administered and its acute effects on mental function and mood were evaluated before product intake, at 30 min, 3 h, and 5 h post-ingestion.
详细描述
The present study is a double-blind, randomized, placebo-controlled crossover clinical trial that aimed to evaluate the effects of a standardized soluble mango leaf extract (Zynamite® S) on cognitive performance and mood. The study included 88 healthy university students aged 18-25 years. Participants received a single 100 mg dose of Zynamite® S or a placebo. Cognitive performance was evaluated by using the Trail Making Test (TMT) to assess executive functions, the Digit Symbol Substitution Test (DSST) for processing speed, and the Stroop Color and Word Test and the Stroop Interference Test to evaluate selective attention and cognitive flexibility. Additionally, mood was assessed using the Spanish short version of the Profile of Mood States (POMS). All the assessments were conducted before product intake, at 30 min, 3 h, and 5 h post-ingestion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being registered as an undergraduate or postgraduate university student
- •Being between 18 and 25 years old
- •Being healthy and free of any relevant medical condition or illness
排除标准
- •Suffering from chronic diseases such as asthma, type 1 diabetes, thyroid diseases (such as hypothyroidism or hyperthyroidism), autoimmune disorders (such as Crohn's disease), and psychiatric conditions such as anxiety disorders, major depression, eating disorders (anorexia, bulimia), attention deficit hyperactivity disorder (ADHD), among others
- •Being pregnant or lactating
- •Having any known intolerance, hypersensitivity, or allergies to any of the ingredients of the investigational products
- •Having intestinal malabsorption problems, as well as learning difficulties, dyslexia, eye problems, or color blindness
- •Intaking of psychoactive substances or medications that could influence the study results, such as consuming >500 mg of caffeine per day (>6 cups of 150 ml filtered coffee) and/or alcohol
- •Having comprehension or communication difficulties that prevent full understanding of the informed consent or effective participation in the study, such as autism spectrum disorders, aphasia, or intellectual disability
研究组 & 干预措施
Placebo
Capsule containing food-grade maltodextrin
干预措施: Placebo (Dietary Supplement)
Zynamite® S 100mg
Capsule containing 100 mg of soluble mango leaf extract (Zynamite® S) standardized to 60% of mangiferin
干预措施: Zynamite® S (Dietary Supplement)
结局指标
主要结局
Changes in Trail Making Test (TMT) Score
时间窗: At baseline (30 minutes before supplement intake), at 30 minutes, 3 hours, and 5 hours after supplement intake.
Changes in the Trail Making Test (TMT) score will be used to evaluate executive functions between placeobo and Zynamite® S groups. This test is divided into two parts wtih 25 items each: Part A (TMT-A), which evaluates psychomotor attention and speed and involves connecting consecutively numbered circles, and Part B (TMT-B), which requires connecting alternating circles of letters and numbers and is used to measure executive function. A longer time taken to complete the test is interpreted as poorer performance.
Changes in Stroop Color and Word & Stroop Interference Score
时间窗: At baseline (30 minutes before supplement intake), at 30 minutes, 3 hours, and 5 hours after supplement intake.
Changes in the Stroop Color and Word Test and Stroop Interefernce Test will be used to assess cognitive functions, such as selective attention and cognitive flexibility between placebo and Zynamite® S groups. The Stroop Color and Word Test consists on three 45-second tasks. First, the participants read color words printed in black ink (the 'P' score). Next, they name the ink color of "XXXX" symbols (the 'C' score). In the final interference stage, the participant must state the ink color of a word that is printed in a conflicting color, such as the word "BLUE" printed in red ink (the 'PC' score). These three scores are then used to calculate a final T score of interference, where a higher score indicates better performance and attention control.
Changes in Digit symbol substitution test (DSST) Score
时间窗: At baseline (30 minutes before supplement intake), at 30 minutes, 3 hours, and 5 hours after supplement intake.
Changes in the Digit symbol substitution test (DSST) will be employed to compare performance on processing speed, attention, and working memory between placebo and Zynamite® S groups. DSST is a paper-and-pencil cognitive test presented on a single sheet of paper, requiring the subject to match symbols with numbers according to a key located at the top of the page. The subject copies the symbol into spaces beneath a row of numbers. The score is based on the number of correct symbols the participant manages to substitute within 90 s.
次要结局
- Changes in Profile of Mood States (POMS) Score(At baseline (30 minutes before supplement intake), at 30 minutes, 3 hours, and 5 hours after supplement intake.)