Mild Cognitive ImpairmentNCT05573269
Improving Effects of Fish Oil Combined With Pine Bark Extract on Cognitive Decline
A study testing FOPE (fish oil + pine extract) in people with Mild Cognitive Impairment, run by Taipei Medical University at 2 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- FOPE (fish oil + pine extract)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- 11 Nov 2021to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- liver disease, kidney disease, hypertension, hyperlipidemia, anemia, cancer
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Taipei Medical University - Shuang Ho Hospital
New Taipei City, 23561
I-Cheng Lin, 886-2-22490088 ext. 79212, 12023@s.tmu.edu.tw
- Recruiting
Taiwan Adventist Hospital
Taipei, 10556
Alex Hsu, 886-2-27718151 ext. 2692, alexhsu588@yahoo.com.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- FOPE (fish oil + pine extract), FO (fish oil +placebo)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOPE (fish oil + pine extract)Dietary supplement
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.
FO (fish oil +placebo)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| FOPE group | Experimental | 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. Receives: Dietary Supplement: FOPE (fish oil + pine extract) |
| FO group | Active comparator | 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. Receives: Other: FO (fish oil +placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination (MMSE)
The most commonly used cognitive function assessment tool in clinical.
Measured: 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)
Measured: 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.
Measured: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Secondary outcomes (15)
Liver function -AST
Serum AST is in units per liter.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Antioxidative status -TBARS
Thiobarbituric acid-reactive substance
Measured: Change from Baseline at the 12th and 24th week
Antioxidative status -GSH/GSSG
glutathione/oxidized glutathione ratio
Measured: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Antioxidative status-Oxidized LDL
Oxidized LDL
Measured: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Antioxidative status-SOD
Superoxide dismutase
Measured: 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.
Measured: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start11 Nov 2021
- Primary completionJun 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573269
- Sponsor's protocol ID
- N202012034
- Status last verified
- May 2022
- First submitted
- 25 Sep 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improving Effects of Fish Oil Supplementation Combined With Pine Bark Extract on Cognition in Aged-related Cognitive Decline
- ClinicalTrials.gov ID
- NCT05573269
- Acronym / sponsor ID
- N202012034
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOPE group | Experimental | Dietary Supplement: FOPE (fish oil + pine extract)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. |
| FO group | Active comparator | Other: FO (fish oil +placebo)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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- liver disease, kidney disease, hypertension, hyperlipidemia, anemia, cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | FOPE group |
| 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. | Other | FO group |
Primary outcome
Mini-Mental State Examination (MMSE)
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
The most commonly used cognitive function assessment tool in clinical.
Clinical Dementia Rating Scale (CDRS)
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
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)
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
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.
15 secondary outcomes
Liver function -AST
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Liver function -ALT
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Kidney function -BUN
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Kidney function -Creatine
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Kidney function -uric acid
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Lipid profile
Time frame: 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
Time frame: 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
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
An outcome related with hematology- platelet
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Nutritional status
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Antioxidative status -TBARS
Time frame: Change from Baseline at the 12th and 24th week
Antioxidative status -GSH/GSSG
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Antioxidative status-Oxidized LDL
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Antioxidative status-SOD
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Lipid composition on red blood cell membrane
Time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOPE (fish oil + pine extract) in people with Mild Cognitive Impairment, run by Taipei Medical University at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suh-Ching Yang (+886-2-2736-1661 ext. 6553, sokei@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (MMSE) (time frame: Change from Baseline and the 12th and 24th week, the experiment will least for 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.