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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
During the experiment period the participants will receive a capsule of pine bark extract (Oligopin® 100mg) and a capsule of fish oil (EPA 350mg + DHA 250mg) a day. Blood collecting (biomedical parameters and antioxidative status) and cognitive function evaluation will be examined at the 0, 12, 24th week. Body composition, 24-hour dietary recall and blood pressure measurement will be measured at 0, 4, 8, 12, 16, 20, 24th week.
During the experiment period the participants will receive a capsule of placebo (maltodextrin + magnesium stearate) and a capsule of fish oil (EPA 350mg + DHA 250mg) a day. Blood collecting (biomedical parameters and antioxidative status) and cognitive function evaluation will be examined at the 0, 12, 24th week. Body composition, 24-hour dietary recall and blood pressure measurement will be measured at 0, 4, 8, 12, 16, 20, 24th week.
Taipei Medical University - Shuang Ho Hospital
New Taipei City, Taiwan
RECRUITINGTaiwan Adventist Hospital
Taipei, Taiwan
RECRUITINGMini-Mental State Examination (MMSE)
The most commonly used cognitive function assessment tool in clinical.
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Clinical Dementia Rating Scale (CDRS)
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)
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Cognitive Ability Screening Instrument (CASI)
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.
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Liver function -AST
Serum AST is in units per liter.
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Liver function -ALT
Serum ALT is in units per liter.
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Kidney function -BUN
Serum BUN is in milligram per deciliter
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
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Kidney function -Creatine
Serum creatine is in milligram per deciliter
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Kidney function -uric acid
Serum uric acid is in milligram per deciliter
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Lipid profile
Serum HDL-Cho, LDL-Cho, triglyceride and total cholesterol are in milligram per deciliter
Time frame: 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
Serum WBC in 1000/uL; neutrophils, lymphocytes, monocytes, eosinophils and basophils are in percentage.
Time frame: 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
RBC in 1000000/uL
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
An outcome related with hematology- platelet
Platelet in 1000/uL
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Nutritional status
Serum albumin is in gram per deciliter
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Antioxidative status -TBARS
Thiobarbituric acid-reactive substance
Time frame: Change from Baseline at the 12th and 24th week
Antioxidative status -GSH/GSSG
glutathione/oxidized glutathione ratio
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Antioxidative status-Oxidized LDL
Oxidized LDL
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Antioxidative status-SOD
Superoxide dismutase
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Lipid composition on red blood cell membrane
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.
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months