Improving Effects of Fish Oil Combined With Pine Bark Extract on Cognitive Decline

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Improving Effects of Fish Oil Supplementation Combined With Pine Bark Extract on Cognition in Aged-related Cognitive Decline

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Dietary Supplement: FOPE (fish oil + pine extract)
* Other: FO (fish oil +placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: liver disease, kidney disease, hypertension, hyperlipidemia, anemia, cancer

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOPE group<br>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. | Dietary Supplement: FOPE (fish oil + pine extract)<br>* 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.<br>|
| Active Comparator: FO group<br>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. | Other: FO (fish oil +placebo)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Mental State Examination (MMSE) | The most commonly used cognitive function assessment tool in clinical. | 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) | 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. | Change from Baseline and the 12th and 24th week, the experiment will least for 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver function -AST | Serum AST is in units per liter. | 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. | 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 | Change from Baseline and the 12th and 24th week, the experiment will least for 6 months | 
| Kidney function -Creatine | Serum creatine is in milligram per deciliter | 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 | 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 | 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. | 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 | 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 | 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 | Change from Baseline and the 12th and 24th week, the experiment will least for 6 months | 
| Antioxidative status -TBARS | Thiobarbituric acid-reactive substance | Change from Baseline at the 12th and 24th week | 
| Antioxidative status -GSH/GSSG | glutathione/oxidized glutathione ratio | Change from Baseline and the 12th and 24th week, the experiment will least for 6 months | 
| Antioxidative status-Oxidized LDL | Oxidized LDL | Change from Baseline and the 12th and 24th week, the experiment will least for 6 months | 
| Antioxidative status-SOD | Superoxide dismutase | 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. | Change from Baseline and the 12th and 24th week, the experiment will least for 6 months |