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Clinical trial to compare the cognitive function improvement effect of mature silkworm pills and nutritional beverage intake group and placebo pill and placebo beverage intake group in mild cognitive impairment

A 12-week randomized and blinded clinical trial to compare the cognitive function improvement effect of mature silkworm pills and nutritional beverage intake groups and placebo pills and placebo beverage intake groups in mild cognitive impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007304
Enrollment
106
Registered
2022-05-18
Start date
2022-05-27
Completion date
Unknown
Last updated
2025-05-07

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 : The test group consumes mature silkworm pills and a nutritional drink, and the control group consumes a placebo pill and a placebo drink. The control nutritional drink (150kcal/20

Sponsors

Ajou University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with mild cognitive impairment who are 50 years of age or older as of the date of consent(For women who have lost fertility due to menopause or surgery, etc., those who have passed 2 years or more) 2. No significant impairment of daily life: K-IADL less than 0.4 3. It must not be dementia in the judgment of the clinician. 4. Can read and write letters. 5. Subject gave written consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. If there is a mental illness such as major depression 2. Dementia 3. Other degenerative brain diseases such as Parkinson's disease 4. Malignant tumors within 5 years that have not been cured 5. Revascularization or stenting within 1 year 6. Severe or unstable symptomatic cardiovascular disease 7. Patients with other medical conditions that may interfere with completion of clinical trials if there is evidence of other severe or unstable physical disease 8. Severe visual impairment, severe hearing impairment, or communication impairment to the extent that interventions and effectiveness evaluations cannot be performed. 9. The illiterate 10. When it is judged that it is difficult for the researcher to cooperate fully in the research 11. If there is difficulty in safely participating in the research in the judgment of the researcher 12. Participating in other drug research or interventional research 13. If you are taking two or more prescription medications for cognitive decline 14. If more than 3 months have not elapsed since starting a new prescription for cognitive decline or adjusting the dose 15. Those who have a clear history of allergy to certain foods or drugs or who have been diagnosed 16. If you are taking other dietary supplements, if more than 3 months have not elapsed since starting or adjusting the dose

Design outcomes

Primary

MeasureTime frame
K-RBANS change amount

Secondary

MeasureTime frame
Changes in K-MMSE, CDR, K-IADL, nutrient intake, blood markers(neurofilament light chain, amyloid ß, total tau, phosphorylated-tau), retention rate, intake compliance

Countries

Korea, Republic of

Contacts

Public ContactKyunghwa Sun

Ajou University Hospital

nabear1001@naver.com+82-31-219-5658

Outcome results

None listed

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