A Clinical Study on the Effect of DHA & ARA Candy on the Cognitive Improvement in Preschool Children of 2-6 Years Old
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of scale of WISC-IV-Chinese asssessment in 2 weeks
研究概览
简要总结
The goal of this interventional study is to evaluate the effectiveness of DHA (docosahexaenoic acid) & ARA (arachidonic acid) Candy on the cognitive development of preschool children (2-6 years old). The main questions it aims to answer are:
- Does DHA & ARA Candy improve the cognitive ability in terms of Wechsler Intelligence Scale for Children 4th edition-Chinese version (WISC-IV-Chinese)?
Researchers will administer the WISC-IV-Chinese following the guidelines strictly and analyze the score to conclude whether the DHA & ARA is effective to improve the cognitive ability of preschool childchildren.
Participants will eat 1-2 candy (each contains 100mg DHA and 100mg ARA) daily for 4 consecutive weeks and take the WISC-IV-Chinese test for three times according to the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be 2-6 years old
- •Healthy children of normal development, without gender restrictions, with a male to female ratio of more than 40%;
- •During the trial period, participants agree not to take any medications, supplements, or other nutritional products containing DHA and ARA;
- •Parents or legal guardians (at least one party) have signed an informed consent form, voluntarily participating in this study and complying with the study design;
- •Willing to not participate in other interventional nutritional studies during the trial period;
- •Capable of fully understanding the nature, purpose, benefits, and potential risks and side effects of this study.
排除标准
- •Allergic to dairy products;
- •Severely intolerant to milk dairy products;
- •Unable to provide written informed consent;
- •During the screening period, or within the past two weeks, has used antibiotics;
- •Currently taking therapeutic medications;
- •The volunteer has any of the following medical histories or has been nutritionally diagnosed with any of the following diseases: significant gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory, or cardiovascular diseases, which may affect the assessment of the trial's effects;
- •Suffering from any gastrointestinal dysfunction or gastrointestinal disease. For example, but not limited to: Irritable Bowel Syndrome (IBS), enteritis, ulcerative colitis, celiac disease, irritable bowel syndrome;
- •Has a history of hospitalization within the past 3 months;
- •According to the researcher's judgment, currently frequently using medications that may affect gastrointestinal function or the immune system.
结局指标
主要结局
Change of scale of WISC-IV-Chinese asssessment in 2 weeks
时间窗: base day 0, week 2
Change of scale of WISC-IV-Chinese (Wechsler Intelligence Scale for Children 4th edition-Chinese version). The WISC-IV-Chinese is an individually administered and norm-referenced instrument designed to measure intelligence for Chinese children. The WISC-IV contains 10 core subtests and five additional subtests. These are summed into a four-index score and one FSIQ, which ranges from the lowest (40) to the highest (160) points.
Change of scale of WISC-IV-Chinese asssessment in 4 weeks
时间窗: base day 0, week 4
Change of scale of WISC-IV-Chinese (Wechsler Intelligence Scale for Children 4th edition-Chinese version). The WISC-IV-Chinese is an individually administered and norm-referenced instrument designed to measure intelligence for Chinese children. The WISC-IV contains 10 core subtests and five additional subtests. These are summed into a four-index score and one FSIQ, which ranges from the lowest (40) to the highest (160) points.
次要结局
- Number of sick leave days(base day 0, week 2, week 4)
- Change of Conners TRS score(base day 0, week 2, week 4)