Clinical trial NCT05573269: Improving Effects of Fish Oil Combined With Pine Bark Extract on Cognitive Decline
Official title: The Improving Effects of Fish Oil Supplementation Combined With Pine Bark Extract on Cognition in Aged-related Cognitive Decline
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
measure: Clinical Dementia Rating Scale (CDRS)
timeFrame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
measure: Cognitive Ability Screening Instrument (CASI)
timeFrame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Secondary outcomes:
measure: Liver function -AST
timeFrame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
measure: Liver function -ALT
timeFrame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
measure: Kidney function -BUN
timeFrame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
measure: Kidney function -Creatine
timeFrame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
measure: Kidney function -uric acid
timeFrame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
measure: Lipid profile
timeFrame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
measure: An outcome related with hematology- white blood cell related measurements
timeFrame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
measure: An outcome related with hematology- red blood cell related measurements
timeFrame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
measure: An outcome related with hematology- platelet
timeFrame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
measure: Nutritional status
timeFrame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
measure: Antioxidative status -TBARS
timeFrame: Change from Baseline at the 12th and 24th week
measure: Antioxidative status -GSH/GSSG
timeFrame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
measure: Antioxidative status-Oxidized LDL
timeFrame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
measure: Antioxidative status-SOD
timeFrame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
measure: Lipid composition on red blood cell membrane
timeFrame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital
city: Taipei
country: Taiwan
facility: Taiwan Adventist Hospital
Study officials:
References: