돼지 뇌 효소 가수분해물 경구 복용이 정상 인지기능 중장년 성인의 기억력 개선에 미치는 영향: 무작위 배정, 이중 맹검, 위약 대조 인체적용시험 = Effects of Oral Intake of Porcine Brain Enzyme Hydrolysate on Memory in Cognitively Healthy Middle-aged and Older Adults: A Randomized, Double-blind, Placebo-controlled Human Trial

다국어 초록 (Multilingual Abstract)

Background
Age-related memory decline and mild cognitive impairment are common concerns among middle-aged and older adults. While pharmacological treatments for cognitive decline have limitations, bioactive compounds such as porcine brain enzyme hydrolysate (PBEH), derived from pig brain tissue, may offer a safer alternative. We aimed to evaluate the efficacy and safety of PBEH supplementation for improving memory in cognitively healthy adults.
Methods
A 24-week, randomized, double-blind, placebo-controlled trial was conducted at Daejeon University Cheonan Korean Medicine Hospital. A total of 100 participants aged 45–70 years were randomized to receive either 250mg of PBEH or a placebo daily. The primary outcome was the change in the global memory score on the Korean version of the Memory Assessment Scale. Secondary outcomes included subdomains of memory, serum biomarkers, and safety assessments.
Results
At 24 weeks, the PBEH group demonstrated a significant improvement in the global memory score compared to the placebo group, with a between-group difference of p = 0.023. Secondary outcomes exhibited significant improvements in short-term and visual memory in the PBEH group. Additionally, β-amyloid protein levels decreased in the PBEH group (p < 0.001), suggesting a potential neuroprotective effect. PBEH was well tolerated, with no serious adverse events.
Conclusion
This study provides evidence that 24 weeks of oral PBEH supplementation significantly improves memory function in middle-aged and older adults. PBEH may offer a promising, safe, and effective intervention to maintain cognitive health in aging populations, with potential neuroprotective effects. Further research is needed to explore long-term benefits and underlying mechanisms.

목차 (Table of Contents)

• 목 차 ⅰ
• 표 목 차 ⅲ
• 그림 목차 ⅳ
• Ⅰ. 서 론 5
• Ⅱ. 연구 방법 7
• 1. 임상 연구의 목적 및 설계 7
• 1) 임상 연구의 목적 7
• 2) 임상 연구의 설계 8
• 2. 임상 연구 대상자 9
• 1) 연구 대상자 9
• 2) 선정기준 10
• 3) 제외기준 10
• 4) 대상자 수 산정 12
• 3. 임상 연구 방법 13
• 1) 무작위 배정 13
• 2) 연구 진행 일정 14
• 3) 중재 17
• 4) 시험 중지 및 탈락기준 18
• 4. 유효성 평가 19
• 1) 1차 유효성 평가 변수 19
• 2) 2차 유효성 평가 변수 19
• 5. 안전성 및 이상반응 평가 20
• 6. 통계 분석 21
• Ⅲ. 연구 결과 22
• 1. 대상자 모집 22
• 2. 인구학적 정보 및 기저 특성 24
• 3. 중재 27
• 4. 유효성 평가 28
• 1) 1차 유효성 평가변수 분석 28
• 2) 2차 유효성 평가변수 분석 29
• 5. 안전성 평가 37
• Ⅳ. 고 찰 41
• Ⅴ. 결 론 45
• 참 고 문 헌 46
• 영 문 초 록 51