Cognitive ChangeNCT06532435
A Clinical Study on the Effect of DHA & ARA Candy on the Cognitive Improvement in Preschool Children
A study testing DHA & ARA Candy in people with Cognitive Change, run by Shandong Sibote Biotechnology Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- DHA & ARA Candy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2024to 10 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)?
Read more
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
- Being tested
- DHA & ARA Candy
- Keywords
- WISC-IV, Cognitive Ability, DHA, ARA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA & ARA CandyDietary supplement
Parpicipants need to eat 1-2 candy daily, for 4 consective weeks
| Study group | Role | What they receive |
|---|---|---|
| DHA & ARA Candy | Other | Sibot DHA algal oil ARA gelainzed Candy, each containing DHA 100 mg + ARA 100 mg Receives: Dietary Supplement: DHA & ARA Candy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: base day 0, week 4
Secondary outcomes (2)
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.
Measured: base day 0, week 2, week 4
Number of sick leave days
Number of sick leave days of participants during the intervention
Measured: base day 0, week 2, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start25 Jun 2024
- Primary completion10 Aug 2024
- Study completion10 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Sibote Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charlie Zhang, MD, Principal investigator, Raison Biotech Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532435
- Sponsor's protocol ID
- 24-RD-06-SBT-001
- Status last verified
- Nov 2024
- First submitted
- 29 Jul 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The abstract of the study result will be shared via a public web link
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Effect of DHA & ARA Candy on the Cognitive Improvement in Preschool Children of 2-6 Years Old
- ClinicalTrials.gov ID
- NCT06532435
- Acronym / sponsor ID
- 24-RD-06-SBT-001
- Conditions
- Cognitive Change
- Keywords
- WISC-IV, Cognitive Ability, DHA, ARA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shandong Sibote Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DHA & ARA Candy | Other | Dietary Supplement: DHA & ARA CandySibot DHA algal oil ARA gelainzed Candy, each containing DHA 100 mg + ARA 100 mg |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHA & ARA CandyParpicipants need to eat 1-2 candy daily, for 4 consective weeks | Dietary supplement | DHA & ARA Candy |
Primary outcome
Change of scale of WISC-IV-Chinese asssessment in 2 weeks
Time frame: base day 0, week 2
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.
Change of scale of WISC-IV-Chinese asssessment in 4 weeks
Time frame: base day 0, week 4
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.
2 secondary outcomes
Change of Conners TRS score
Time frame: base day 0, week 2, week 4
Number of sick leave days
Time frame: base day 0, week 2, week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: Yes. The abstract of the study result will be shared via a public web link
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlie Zhang, MD principal investigator
Raison Biotech Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHA & ARA Candy in people with Cognitive Change, run by Shandong Sibote Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of scale of WISC-IV-Chinese asssessment in 2 weeks (time frame: base day 0, week 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.