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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05573269
• Other study ID #: N202012034
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: July 2023

Study information

• Verified date: May 2022
• Source: Taipei Medical University
• Contact: Suh-Ching Yang
• Phone: +886-2-2736-1661
• Email: sokei[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Dietary Supplement:
• FOPE (fish oil + pine extract)
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.

Other:
• FO (fish oil +placebo)
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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University - Shuang Ho Hospital	New Taipei City
Taiwan	Taiwan Adventist Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Antioxidative status -TBARS	Thiobarbituric acid-reactive substance	Change from Baseline at the 12th and 24th week
Secondary	Antioxidative status -GSH/GSSG	glutathione/oxidized glutathione ratio	Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Secondary	Antioxidative status-Oxidized LDL	Oxidized LDL	Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Secondary	Antioxidative status-SOD	Superoxide dismutase	Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Secondary	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