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

Primary Purpose

Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
FOPE (fish oil + pine extract)
FO (fish oil +placebo)
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taipei Medical University - Shuang Ho HospitalRecruiting
  • Taiwan Adventist HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FOPE group

FO group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mini-Mental State Examination (MMSE)
The most commonly used cognitive function assessment tool in clinical.
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)
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.

Secondary Outcome Measures

Liver function -AST
Serum AST is in units per liter.
Liver function -ALT
Serum ALT is in units per liter.
Kidney function -BUN
Serum BUN is in milligram per deciliter
Kidney function -Creatine
Serum creatine is in milligram per deciliter
Kidney function -uric acid
Serum uric acid is in milligram per deciliter
Lipid profile
Serum HDL-Cho, LDL-Cho, triglyceride and total cholesterol are in milligram per deciliter
An outcome related with hematology- white blood cell related measurements
Serum WBC in 1000/uL; neutrophils, lymphocytes, monocytes, eosinophils and basophils are in percentage.
An outcome related with hematology- red blood cell related measurements
RBC in 1000000/uL
An outcome related with hematology- platelet
Platelet in 1000/uL
Nutritional status
Serum albumin is in gram per deciliter
Antioxidative status -TBARS
Thiobarbituric acid-reactive substance
Antioxidative status -GSH/GSSG
glutathione/oxidized glutathione ratio
Antioxidative status-Oxidized LDL
Oxidized LDL
Antioxidative status-SOD
Superoxide dismutase
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.

Full Information

First Posted
September 25, 2022
Last Updated
October 7, 2022
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05573269
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FOPE group
Arm Type
Experimental
Arm Description
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.
Arm Title
FO group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
FOPE (fish oil + pine extract)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
FO (fish oil +placebo)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mini-Mental State Examination (MMSE)
Description
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
Title
Clinical Dementia Rating Scale (CDRS)
Description
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
Title
Cognitive Ability Screening Instrument (CASI)
Description
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
Secondary Outcome Measure Information:
Title
Liver function -AST
Description
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
Title
Liver function -ALT
Description
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
Title
Kidney function -BUN
Description
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
Title
Kidney function -Creatine
Description
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
Title
Kidney function -uric acid
Description
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
Title
Lipid profile
Description
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
Title
An outcome related with hematology- white blood cell related measurements
Description
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
Title
An outcome related with hematology- red blood cell related measurements
Description
RBC in 1000000/uL
Time Frame
Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Title
An outcome related with hematology- platelet
Description
Platelet in 1000/uL
Time Frame
Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Title
Nutritional status
Description
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
Title
Antioxidative status -TBARS
Description
Thiobarbituric acid-reactive substance
Time Frame
Change from Baseline at the 12th and 24th week
Title
Antioxidative status -GSH/GSSG
Description
glutathione/oxidized glutathione ratio
Time Frame
Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Title
Antioxidative status-Oxidized LDL
Description
Oxidized LDL
Time Frame
Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Title
Antioxidative status-SOD
Description
Superoxide dismutase
Time Frame
Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Title
Lipid composition on red blood cell membrane
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suh-Ching Yang
Phone
+886-2-2736-1661
Ext
6553
Email
sokei@tmu.edu.tw
Facility Information:
Facility Name
Taipei Medical University - Shuang Ho Hospital
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I-Cheng Lin
Phone
886-2-22490088
Ext
79212
Email
12023@s.tmu.edu.tw
Facility Name
Taiwan Adventist Hospital
City
Taipei
ZIP/Postal Code
10556
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Hsu
Phone
886-2-27718151
Ext
2692
Email
alexhsu588@yahoo.com.tw

12. IPD Sharing Statement

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

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