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

NCT05573269 | Unknown

• 1 other identifier: N202012034
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (15)

• Liver function -AST

  Change from Baseline and the 12th and 24th week, the experiment will least for 6 months

• Liver function -ALT

  Change from Baseline and the 12th and 24th week, the experiment will least for 6 months

• Kidney function -BUN

  Change from Baseline and the 12th and 24th week, the experiment will least for 6 months

• Kidney function -Creatine

  Change from Baseline and the 12th and 24th week, the experiment will least for 6 months

• Kidney function -uric acid

  Change from Baseline and the 12th and 24th week, the experiment will least for 6 months

Study Arms (2)

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.

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.

Other: FO (fish oil +placebo)

Interventions

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.

FOPE group

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.

FO group

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• liver disease, kidney disease, hypertension, hyperlipidemia, anemia, cancer

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (2)

Taipei Medical University - Shuang Ho Hospital

New Taipei City, 23561, Taiwan

RECRUITING

Taiwan Adventist Hospital

Taipei, 10556, Taiwan

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Fish Oils; pycnogenols

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oils; Lipids

Central Study Contacts

Suh-Ching Yang

CONTACT

+886-2-2736-1661; sokei@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: October 10, 2022
• Study Start: November 11, 2021
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: October 10, 2022

Record last verified: 2022-05

Locations

TW (2)