Clinical trial NCT06532435: A Clinical Study on the Effect of DHA & ARA Candy on the Cognitive Improvement in Preschool Children
Official title: A Clinical Study on the Effect of DHA & ARA Candy on the Cognitive Improvement in Preschool Children of 2-6 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Keywords: WISC-IV
Cognitive Ability
DHA
ARA
Lead sponsor: Shandong Sibote Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change of scale of WISC-IV-Chinese asssessment in 2 weeks
timeFrame: base day 0, week 2
measure: Change of scale of WISC-IV-Chinese asssessment in 4 weeks
timeFrame: base day 0, week 4
Secondary outcomes:
measure: Change of Conners TRS score
timeFrame: base day 0, week 2, week 4
measure: Number of sick leave days
timeFrame: base day 0, week 2, week 4
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Raison Biotech Group Shanghai Lab
state: Shanghai
Study officials:
affiliation: Raison Biotech Group
name: Charlie Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: