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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-25

Study Completion Date

2024-08-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Cognitive Change

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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DHA & ARA Candy

Sibot DHA algal oil ARA gelainzed Candy, each containing DHA 100 mg + ARA 100 mg

Group Type OTHER

DHA & ARA Candy

Intervention Type DIETARY_SUPPLEMENT

Parpicipants need to eat 1-2 candy daily, for 4 consective weeks

Interventions

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DHA & ARA Candy

Parpicipants need to eat 1-2 candy daily, for 4 consective weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes