The Improving Effects of Fish Oil Supplementation Combined With Pine Bark Extract on Cognition in Aged-related Cognitive Decline
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Mini-Mental State Examination (MMSE)
研究概览
简要总结
The purpose of this study is to evaluate the improving effects of ω-3 fatty acid from fish oil combined with polyphenolic extract from pine bark (PE) on cognitive functions and biological parameters in healthy people aged 55 to 75.
详细描述
Sixty participants who meet the inclusion criteria will be randomly divided into two groups. Participants in FO group will be provided one capsule of fish oil (350mg EPA + 250mg DHA) per day for 6 months. Moreover, participants in FOPE group will be provided one capsule of fish oil (350mg EPA + 250mg DHA) combined with PE (100mg Oligopin) per day for 6 months. A cognitive function evaluation, blood biological analysis and antioxidative status will be carried out at the baseline, 3 th month and the end of the supplementation period. On the other hand, blood fatty acid composition will be measured at the baseline and the end of the supplementation period. All participants will come to laboratory and receive the supplements every month. At the same time, they will accept the measurement of body weight and blood pressure, also be interviewed with 24 hours dietary recall questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •I. 55~75 years old
- •II. No severe diseases, such as hyperlipidemia, diabetes, heart diseases, cancer etc.
- •III. Mini-mental state examination (MMSE) score is more than 26
- •IV. Clinical dementia rating scale (CDRS) score is less than 0.5
排除标准
- •liver disease, kidney disease, hypertension, hyperlipidemia, anemia, cancer
结局指标
主要结局
Mini-Mental State Examination (MMSE)
时间窗: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
The most commonly used cognitive function assessment tool in clinical.
Clinical Dementia Rating Scale (CDRS)
时间窗: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
CDR is a rating scale for staging patients diagnosed with dementia. no dementia (CDR = 0), questionable dementia (CDR = 0.5), MCI (CDR = 1), moderate cognitive impairment (CDR = 2), and severe cognitive impairment (CDR = 3)
Cognitive Ability Screening Instrument (CASI)
时间窗: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
CASI is a cognitive test screening for dementia. For monitoring the disease progression and providing profiles of cognitive impairment by examining abilities on attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, list-generating fluency and abstraction.
次要结局
- Antioxidative status-SOD(Change from Baseline and the 12th and 24th week, the experiment will least for 6 months)
- Kidney function -BUN(Change from Baseline and the 12th and 24th week, the experiment will least for 6 months)
- Liver function -ALT(Change from Baseline and the 12th and 24th week, the experiment will least for 6 months)
- An outcome related with hematology- platelet(Change from Baseline and the 12th and 24th week, the experiment will least for 6 months)
- Antioxidative status-Oxidized LDL(Change from Baseline and the 12th and 24th week, the experiment will least for 6 months)
- Kidney function -Creatine(Change from Baseline and the 12th and 24th week, the experiment will least for 6 months)
- Nutritional status(Change from Baseline and the 12th and 24th week, the experiment will least for 6 months)
- Lipid composition on red blood cell membrane(Change from Baseline and the 12th and 24th week, the experiment will least for 6 months)
- Kidney function -uric acid(Change from Baseline and the 12th and 24th week, the experiment will least for 6 months)
- Lipid profile(Change from Baseline and the 12th and 24th week, the experiment will least for 6 months)
- Antioxidative status -TBARS(Change from Baseline at the 12th and 24th week)
- Liver function -AST(Change from Baseline and the 12th and 24th week, the experiment will least for 6 months)
- An outcome related with hematology- white blood cell related measurements(Change from Baseline and the 12th and 24th week, the experiment will least for 6 months)
- An outcome related with hematology- red blood cell related measurements(Change from Baseline and the 12th and 24th week, the experiment will least for 6 months)
- Antioxidative status -GSH/GSSG(Change from Baseline and the 12th and 24th week, the experiment will least for 6 months)