A Clinical Trial to Assess the Efficacy of a Plant-based Energy Shot on Focus and ADHD-like Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Attention-deficit/hyperactivity disorder (ADHD)-like symptoms. [Time Frame: Baseline to Day 28]
研究概览
简要总结
This is a virtual, single-arm clinical trial that will last 28 days. Participants will drink 1 bottle of Proper Wild energy shot daily and complete questionnaires at baseline, day 1, day 14, and day 28.
Attention deficit hyperactivity disorder (ADHD)-like symptoms, such as concentration, focus, and attention, will be evaluated at baseline and at each check-in. Likert scale responses will be examined from baseline to each check-in. Participant responses on product feedback will be presented as % scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently experiencing symptoms associated with ADHD, including:
- •Impulsiveness. Disorganization and problems prioritizing Poor time management skills Problems focusing on a task Trouble multitasking Excessive activity or restlessness Poor planning
- •Age 18-55
- •Self-reported issues with focus and/or productivity
- •Generally healthy - don't live with any uncontrolled chronic disease
排除标准
- •Currently taking prescription medication for ADHD
- •Currently supplementing with L-Theanine.
- •Known to respond negatively to caffeine (no effect, makes them sleepy or feel unwell)
- •People with a high caffeine tolerance defined as regular consumption of >400mg of caffeine (>4 coffees) per day.
- •Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- •Anyone with known severe allergic reactions.
- •Women who are pregnant, breastfeeding, or attempting to become pregnant
- •Unwilling to follow the study protocol.
结局指标
主要结局
Change in Attention-deficit/hyperactivity disorder (ADHD)-like symptoms. [Time Frame: Baseline to Day 28]
时间窗: 28 days
Survey-based assessment (0-5) scale of changes in symptoms associated with ADHD. Parameters explored include focus \& concentration, productivity, mood, and "brain fog".
次要结局
- Assess the product as a replacement for coffee or caffeinated beverages. [Time Frame: Baseline to Day 28](28 days)