Improving Effects of Fish Oil Combined With Pine Bark Extract on Cognitive Decline
- Conditions
- Mild Cognitive Impairment
- Interventions
- Dietary Supplement: FOPE (fish oil + pine extract)Other: FO (fish oil +placebo)
- Registration Number
- NCT05573269
- Lead Sponsor
- Taipei Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- liver disease, kidney disease, hypertension, hyperlipidemia, anemia, cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FOPE group FOPE (fish oil + pine extract) Dietary supplement, Polyphenolic extract from pine bark (Oligopin® 100mg) and fish oil capsule contained EPA 350mg + DHA 250mg. This group will receive a nutritional supplement for a period of 6 months. The participants will have a capsule of polyphenolic extract and a capsule of fish oil a day. FO group FO (fish oil +placebo) This group will have placebo capsule and fish oil capsule. Placebo capsule contained maltodextrin and magnesium stearate, while fish oil contained EPA 350mg + DHA 250mg. The participants will receive the supplements for a period of 6 months and have a capsule of placebo and a capsule of fish oil a day.
- Primary Outcome Measures
Name Time Method Mini-Mental State Examination (MMSE) 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) 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) 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.
- Secondary Outcome Measures
Name Time Method Antioxidative status-SOD Change from Baseline and the 12th and 24th week, the experiment will least for 6 months Superoxide dismutase
Kidney function -BUN Change from Baseline and the 12th and 24th week, the experiment will least for 6 months Serum BUN is in milligram per deciliter
Liver function -ALT Change from Baseline and the 12th and 24th week, the experiment will least for 6 months Serum ALT is in units per liter.
An outcome related with hematology- platelet Change from Baseline and the 12th and 24th week, the experiment will least for 6 months Platelet in 1000/uL
Antioxidative status-Oxidized LDL Change from Baseline and the 12th and 24th week, the experiment will least for 6 months Oxidized LDL
Kidney function -Creatine Change from Baseline and the 12th and 24th week, the experiment will least for 6 months Serum creatine is in milligram per deciliter
Nutritional status Change from Baseline and the 12th and 24th week, the experiment will least for 6 months Serum albumin is in gram per deciliter
Lipid composition on red blood cell membrane Change from Baseline and the 12th and 24th week, the experiment will least for 6 months Lipid composition on the cell membrane of red blood cell. It will be analyzed by GC/MS system and based on the protocol of Wang et al. The composition of C16:0, C18:0, C18:1, C18:2, C18:3, C20:4, C20:5, C22:5, C22:6, saturated fatty acids, polyunsaturated fatty acids, monounsaturated fatty acids, total n-3 fatty acids, total n-6 fatty acids and the ratio of n-3 and n-6 will be measured.
C16:0, C18:0, C18:1, C18:2, C18:3, C20:4, C20:5, C22:5, C22:6, saturated fatty acids, polyunsaturated fatty acids, monounsaturated fatty acids, total n-3 fatty acids, total n-6 fatty acids are in percentage.Kidney function -uric acid Change from Baseline and the 12th and 24th week, the experiment will least for 6 months Serum uric acid is in milligram per deciliter
Lipid profile Change from Baseline and the 12th and 24th week, the experiment will least for 6 months Serum HDL-Cho, LDL-Cho, triglyceride and total cholesterol are in milligram per deciliter
Antioxidative status -TBARS Change from Baseline at the 12th and 24th week Thiobarbituric acid-reactive substance
Liver function -AST Change from Baseline and the 12th and 24th week, the experiment will least for 6 months Serum AST is in units per liter.
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 Serum WBC in 1000/uL; neutrophils, lymphocytes, monocytes, eosinophils and basophils are in percentage.
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 RBC in 1000000/uL
Antioxidative status -GSH/GSSG Change from Baseline and the 12th and 24th week, the experiment will least for 6 months glutathione/oxidized glutathione ratio
Trial Locations
- Locations (2)
Taipei Medical University - Shuang Ho Hospital
🇨🇳New Taipei City, Taiwan
Taiwan Adventist Hospital
🇨🇳Taipei, Taiwan