Phospholipids as Nutritional Support for Reduction of Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- General Anxiety Disorder-7 (GAD-7) Questionnaire
研究概览
简要总结
The goal of this clinical trial is to learn about the effects of a milk-based dietary supplement in adults that report regular and frequent episodes of intermittent anxiety. The main question it aims to answer is: Can this extract be used to reduced symptoms of intermittent anxiety?
Participants will consume the milk-based dietary supplement every morning for 4 weeks and each week they will fill out 3 different questionnaires.
详细描述
Clinical study evaluating the effects of a dietary milk-based supplement to help reduce symptoms of anxiety. The milk-based supplement is a fat-rich fraction of whey, rich in phospholipids.
24 subjects who report frequent and regular episodes of intermittent anxiety will participate in a questionnaire based clinical trial, wherein they will be consuming the milk-based dietary supplement each morning for 4 weeks.
Each week subjects will fill out 2 questionnaires evaluating their anxiety and 1 questionnaire evaluating their sleep. Changes in stress will be measured relative to baseline scores, collected during the first week before supplement consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult people of any gender
- •Age 18-75 years (inclusive)
- •BMI between 18.0 and 34.0 (inclusive)
- •Experiencing intermittent episodes of anxiety on a regular basis, leading to either avoiding specific situations, or experiencing stress both in anticipation of, and during such situations.
- •Specific situations that occur regularly that cause anxiety, for example:
- •Performing specific tasks at work or at home
- •Inter-personal conflicts at work or at home
- •Driving or commuting
- •Fearful and worrying about one's own situation (such as paying bills)
- •Worrying about ongoing problems experienced by others
排除标准
- •Cancer during the past 12 months
- •Chemotherapy during the past 12 months
- •Currently taking anxiolytic, hypnotic, or anti-depressant prescription medication
- •Currently taking nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product
- •Food allergies or insensitivity related to lactose or other ingredients in test product
- •People who are pregnant, nursing, or trying to become pregnant
结局指标
主要结局
General Anxiety Disorder-7 (GAD-7) Questionnaire
时间窗: 1 week, 2 weeks, 3 weeks, 4 weeks
Change from baseline in anxiety score using the General Anxiety Disorder 7-item. The General Anxiety Disorder-7 scale evaluates anxiety severity using scores ranging from 0-21, higher scores indicate higher anxiety severity, a worse outcome.
次要结局
- Overall Anxiety Severity and Impairment Scale (OASIS) Questionnaire(1 week, 2 weeks, 3 weeks, 4 weeks)