Effect of Krill Oil on Cognitive Function in Adults

NCT04347421 | Completed

• 1 other identifier: 02-2020-006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Krill oil on cognitive function in adults with subjective memory impairment for 12 weeks.

Conditions

Subjective Memory Impairment

Outcome Measures

Primary Outcomes (1)

• Mini-Mental State Examination total score

  Change in Mini-Mental State Examination total score during 3 months

  Change from Baseline Mini-Mental State Examination total score at 3 months

Secondary Outcomes (3)

• Korean instrumental activity of daily living total score

  Change in Korean instrumental activity of daily living total score during 3 months

• Computerized NeuroCognitive Function test total score

  Change in Computerized NeuroCognitive Function test total score during 3 months

• brain derived neurotrophic factor

  Change in brain derived neurotrophic factor level during 3 months

Study Arms (2)

Krill oil group

EXPERIMENTAL

This group takes Krill oil for 12 weeks

Dietary Supplement: Krill oil group

Placebo group

PLACEBO COMPARATOR

This group takes Placebo for 12 weeks

Dietary Supplement: Placebo group

Interventions

Krill oil group DIETARY_SUPPLEMENT

This group takes 500 mg/day Krill oil for 12 weeks.

Krill oil group

Placebo group DIETARY_SUPPLEMENT

This group takes 500 mg/day Placebo for 12 weeks.

Placebo group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Global Deterioration Scale (GDS) 2 or 3

You may not qualify if:

• Abnormal liver or renal function (i.e., serum aminotransferase activity \> 3 times of upper limit of reference range and serum creatinine concentrations \> 1.2 mg/dL)
• Diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dL)
• History of viral hepatitis or cancer
• Uncontrolled hypertension
• History of serious cardiac disease such as angina or myocardial infarction
• History of gastrectomy
• History of medication for psychiatric disease
• Administration of oriental medicine including herbs within the past 4 weeks

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

Location

Study Officials

• Sang Yeoup Lee, MD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 15, 2020
• Study Start: April 10, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 31, 2021
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)