Effect of Krill Oil on Cognitive Function in Adults

Subjective Memory Impairment Clinical Trial

Official title:

Effect of Krill Oil on Cognitive Function in Adults With Subjective Memory Impairment: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347421
• Other study ID #: 02-2020-006
• Status: Completed
• Phase: N/A
• Start date: April 10, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Previous animal studies have indicated that Krill oil may have the ability to improve cognitive function. Therefore, 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; the safety of the compound are also evaluate. The Investigators examine chemical and metabolic parameters, and cognitive function at baseline, as well as after 6 and 12 weeks of intervention. One hundred adults were administered either 500 mg of Krill oil or a placebo each day for 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• Global Deterioration Scale (GDS) 2 or 3

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Memory Disorders
• Subjective Memory Impairment

Intervention

Dietary Supplement:
• Krill oil group
This group takes 500 mg/day Krill oil for 12 weeks.
• Placebo group
This group takes 500 mg/day Placebo for 12 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeungsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Korean instrumental activity of daily living total score	Change in Korean instrumental activity of daily living total score during 3 months	Change in Korean instrumental activity of daily living total score during 3 months
Secondary	Computerized NeuroCognitive Function test total score	Change in Computerized NeuroCognitive Function test total score during 3 months	Change in Computerized NeuroCognitive Function test total score during 3 months
Secondary	brain derived neurotrophic factor	Change in brain derived neurotrophic factor level during 3 months	Change in brain derived neurotrophic factor level during 3 months