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A 8 week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of OFE on Memory Improvement of Adolescent

A 8 week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of OFE on Memory Improvement of Adolescent

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008170
Enrollment
56
Registered
2023-02-10
Start date
2021-06-05
Completion date
Unknown
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Take 3 tablets of test food (1,920 mg/day as extract from Opuntia ficus-indica) or placebo(850mg/capsule) once a day with water.

Sponsors

Konkuk University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Teenagers over 12 years of age and under 18 years of age 2) A person who can read and read the Korean language 3) A person who agrees to participate in this human body application test before the human body application test begins and prepares a written consent form.

Exclusion criteria

Exclusion criteria: 1) Person who scored 30 points as a result of MoCA-K in Visit 1 2) Persons diagnosed with intellectual disability or ADHD 3) A person diagnosed with a psychiatric disease that may affect cognitive function; 4) A person who has taken neuropsychiatric medication within 4 weeks based on visit 1 5) A person who has taken medication or health functional food related to memory improvement within 4 weeks based on visit 1. 6) Patients with uncontrolled hypertension (systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, measured after 10 minutes of rest for those subject to human application tests) 7) Patients with uncontrolled diabetes (above 180 mg/dL of fasting blood sugar) 8) an uncontrolled thyroid patient 9) Those with a creatine level of at least twice the normal upper limit of the implementing institution. 10) Those whose AST (GOT) or ALT (GPT) is at least three times the normal upper limit of the agency. 11) A person who has participated in another interventional clinical trial (including the human body application test) within 3 months of visit 1 or plans to participate in another interventional clinical trial (including the human body application test) after the start of this human body application test 12) A person who is sensitive to or allergic to food ingredients for human application tests 13) A person who the tester deems inappropriate for this human body application test

Design outcomes

Primary

MeasureTime frame
MQ score, immediate recovery index, delayed recovery index, qualitative score of Rey-Kim memory test

Secondary

MeasureTime frame
MoCA-K Total Score;Digit Span Test

Countries

Korea, Republic of

Contacts

Public ContactSeung-ho YOO

Konkuk University Medical Center

shryu.md@gmail.com+82-2-2030-7567

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026