A Clinical Study to Evaluate the Efficacy and Safety of 2’-FL on Improvement of Cognitive including Memory Function.

A 12 Week, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of 2’-FL on Improvement of Cognitive including Memory Function.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010703

Enrollment

100

Registered

2025-07-02

Start date

2024-01-04

Completion date

Unknown

Last updated

2025-07-21

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 : Intervention group: Take one sachet (3.5 g) daily before meals with water for 12 weeks Control group (placebo): Take one sachet daily in the same manner

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adults aged 50 to 80 years at screening 2) memory score between -2.0 SD and -1.0 SD 3) Depression Scale score = 8 4) Able to read and understand Korean 5) Voluntarily agreed to participate after informed consent and willingness to comply with study requirements

Exclusion criteria

Exclusion criteria: 1) Participation in another clinical trial within the past 2 months 2) Diagnosed neurocognitive disorders accompanied by severe mental illness and cognitive decline 3) History of head trauma with loss of consciousness, brain diseases, cardiovascular events, or dizziness within the last 6 months 4) Use of cognition-affecting health supplements or medications 5) Excessive alcohol use 6) Excessive smoking 7) Known allergy or hypersensitivity to any component of the study product 8) Clinically significant medical conditions (liver, kidney, cardiovascular, respiratory, endocrine, CNS, hematologic disorders) or active cancer 9) Pregnant, breastfeeding, or unwilling to use effective contraception 10) Screening lab abnormalities: AST/ALT >2x upper limit of normal, eGFR <60 mL/min/1.73m² 11) Uncontrolled hypertension 12) Any other reason deemed inappropriate by the principal investigator

Design outcomes

Primary

Measure	Time frame
Change in total score on the Alzheimer's Disease Assessment Scale–Cognitive Subscale(ADAS-Cog) ;Change in Digit Span Test score	—

Secondary

Measure	Time frame
Change in Alzheimer's Disease Assessment Scale–Cognitive Subscale(ADAS-Cog) memory score;Change in serum inflammatory cytokines ;Change in amyloid-ß levels	—

Countries

Korea, Republic of

Contacts

Public ContactJongcheon Joo

Wonkwang University Oriental Medical Hospital, Jeonju

jcjoo2000@hanmail.net+82-63-270-1188

Outcome results