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

NCT06532435 | Completed

• 1 other identifier: 24-RD-06-SBT-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change

Keywords

WISC-IV; Cognitive Ability; DHA; ARA

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change of Conners TRS score

  base day 0, week 2, week 4

• Number of sick leave days

  base day 0, week 2, week 4

Study Arms (1)

DHA & ARA Candy

OTHER

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

Dietary Supplement: DHA & ARA Candy

Interventions

DHA & ARA Candy DIETARY_SUPPLEMENT

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

DHA & ARA Candy

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Sibote Biotechnology Co., Ltd.: lead

Study Sites (1)

Raison Biotech Group Shanghai Lab

Shanghai, Shanghai Municipality, China

Location

Study Officials

• Charlie Zhang, MD

  Raison Biotech Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: June 25, 2024
• Primary Completion: August 10, 2024
• Study Completion: August 10, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The abstract will be available in early November, 2024, and there is no end date for the sharing unless further notice.
• 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

Locations

CN (1)