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Effect of Krill Oil on Cognitive Function in Adults

Primary Purpose

Subjective Memory Impairment

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Krill oil group
Placebo group
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subjective Memory Impairment

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Krill oil group

Placebo group

Arm Description

This group takes Krill oil for 12 weeks

This group takes Placebo for 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 12, 2020
Last Updated
April 23, 2022
Sponsor
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04347421
Brief Title
Effect of Krill Oil on Cognitive Function in Adults
Official Title
Effect of Krill Oil on Cognitive Function in Adults With Subjective Memory Impairment: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Memory Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Krill oil group
Arm Type
Experimental
Arm Description
This group takes Krill oil for 12 weeks
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This group takes Placebo for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Krill oil group
Intervention Description
This group takes 500 mg/day Krill oil for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo group
Intervention Description
This group takes 500 mg/day Placebo for 12 weeks.
Primary Outcome Measure Information:
Title
Mini-Mental State Examination total score
Description
Change in Mini-Mental State Examination total score during 3 months
Time Frame
Change from Baseline Mini-Mental State Examination total score at 3 months
Secondary Outcome Measure Information:
Title
Korean instrumental activity of daily living total score
Description
Change in Korean instrumental activity of daily living total score during 3 months
Time Frame
Change in Korean instrumental activity of daily living total score during 3 months
Title
Computerized NeuroCognitive Function test total score
Description
Change in Computerized NeuroCognitive Function test total score during 3 months
Time Frame
Change in Computerized NeuroCognitive Function test total score during 3 months
Title
brain derived neurotrophic factor
Description
Change in brain derived neurotrophic factor level during 3 months
Time Frame
Change in brain derived neurotrophic factor level during 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeungsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Krill Oil on Cognitive Function in Adults

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