Status:
COMPLETED
A Clinical Study on the Effect of DHA & ARA Candy on the Cognitive Improvement in Preschool Children
Lead Sponsor:
Shandong Sibote Biotechnology Co., Ltd.
Conditions:
Cognitive Change
Eligibility:
All Genders
2-6 years
Phase:
NA
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)....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06532435
Start Date
June 25 2024
End Date
August 10 2024
Last Update
November 5 2024
Active Locations (1)
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1
Raison Biotech Group Shanghai Lab
Shanghai, Shanghai Municipality, China