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

Taipei Medical University

Status: Unknown

Conditions: Mild Cognitive Impairment

Treatments: Dietary Supplement: FOPE (fish oil + pine extract); Other: FO (fish oil +placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT05573269

N202012034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

FOPE group

Experimental group

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.

Treatment:

Dietary Supplement: FOPE (fish oil + pine extract)

FO group

Active Comparator group

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.

Treatment:

Other: FO (fish oil +placebo)