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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Dietary supplement: FOPE (fish oil + pine extract); Other: FO (fish oil +placebo)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suh-Ching Yang; Phone Number: 6553 +886-2-2736-1661; Email: sokei@tmu.edu.tw

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 23561
    • Recruiting
    • Taipei Medical University - Shuang Ho Hospital
    • Contact: I-Cheng Lin; Phone Number: 79212 886-2-22490088; Email: 12023@s.tmu.edu.tw
  • Taipei, Taiwan, 10556
    • Recruiting
    • Taiwan Adventist Hospital
    • Contact: Alex Hsu; Phone Number: 2692 886-2-27718151; Email: alexhsu588@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FOPE group; 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); 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.
Active Comparator: FO group; 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); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: September 25, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: N202012034

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No