A Clinical Study on the Effect of DHA & ARA Candy on the Cognitive Improvement in Preschool Children

Shandong Sibote Biotechnology Co., Ltd.

Status

Completed

Conditions

Cognitive Change

Treatments

Dietary Supplement: DHA & ARA Candy

Study type

Interventional

Funder types

Industry

Identifiers

NCT06532435

24-RD-06-SBT-001

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

2 to 6 years old

Volunteers

Accepts Healthy Volunteers

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.