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

A Clinical Study on the Effect of DHA & ARA Candy on the Cognitive Improvement in Preschool Children of 2-6 Years Old

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Change
• Intervention / Treatment: Dietary supplement: DHA & ARA Candy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Raison Biotech Group Shanghai Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DHA & ARA Candy; Sibot DHA algal oil ARA gelainzed Candy, each containing DHA 100 mg + ARA 100 mg	Dietary supplement: DHA & ARA Candy; Parpicipants need to eat 1-2 candy daily, for 4 consective weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of scale of WISC-IV-Chinese asssessment in 2 weeks	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.	base day 0, week 2
Change of scale of WISC-IV-Chinese asssessment in 4 weeks	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.	base day 0, week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Conners TRS score	Change in TRS (Conners' Teacher Rating Scale, TRS ) score over time during the intervention. The Teacher Rating Scales (TRS) are used to measure adaptive and problem behaviors in the preschool or school setting. Teachers or other qualified observers can complete forms at three age levels-preschool (ages 2 to 5), child (ages 6 to 11), and adolescent (ages 12 to 21). The Conners' Teacher Rating Scale we used is a 28-item instrument used to assess children's behavior, each item has four-choice options: 0 = Not True at All (Never, Seldom), 1 = Just a Little True (Occasionally), 2 = Pretty Much True (Often, Quite a Bit), and 3 = Very Much True (Very Often, Very Frequent). The total score ranges from 0 to 54; the smaller the score, the better the behavior.	base day 0, week 2, week 4
Number of sick leave days	Number of sick leave days of participants during the intervention	base day 0, week 2, week 4

Collaborators and Investigators

• Sponsor: Shandong Sibote Biotechnology Co., Ltd.
• Investigators: Principal Investigator: Charlie Zhang, MD, Raison Biotech Group

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Actual): August 10, 2024
• Study Completion (Actual): August 10, 2024

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 3, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: DHA; Cognitive Ability; ARA; WISC-IV
• Other Study ID Numbers: 24-RD-06-SBT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The abstract of the study result will be shared via a public web link
• IPD Sharing Time Frame: The abstract will be available in early November, 2024, and there is no end date for the sharing unless further notice.
• IPD Sharing Access Criteria: The study result is available to access for the public via the following link http://www.raisonbiotech.com/Data/24-RD-06-SBT-001-Abstract.pdf
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No