- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04347421
Effect of Krill Oil on Cognitive Function in Adults
April 23, 2022 updated by: Sang Yeoup Lee, Pusan National University Yangsan Hospital
Effect of Krill Oil on Cognitive Function in Adults With Subjective Memory Impairment: a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeungsangnam-do
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Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
- Pusan National University Yangsan Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo group
This group takes Placebo for 12 weeks
|
This group takes 500 mg/day Placebo for 12 weeks.
|
Experimental: Krill oil group
This group takes Krill oil for 12 weeks
|
This group takes 500 mg/day Krill oil for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mini-Mental State Examination total score
Time Frame: Change from Baseline Mini-Mental State Examination total score at 3 months
|
Change in Mini-Mental State Examination total score during 3 months
|
Change from Baseline Mini-Mental State Examination total score at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Korean instrumental activity of daily living total score
Time Frame: 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
|
Change in Korean instrumental activity of daily living total score during 3 months
|
Computerized NeuroCognitive Function test total score
Time Frame: Change in Computerized NeuroCognitive Function test total score during 3 months
|
Change in Computerized NeuroCognitive Function test total score during 3 months
|
Change in Computerized NeuroCognitive Function test total score during 3 months
|
brain derived neurotrophic factor
Time Frame: Change in brain derived neurotrophic factor level during 3 months
|
Change in brain derived neurotrophic factor level during 3 months
|
Change in brain derived neurotrophic factor level during 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2020
Primary Completion (Actual)
December 30, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
April 12, 2020
First Submitted That Met QC Criteria
April 12, 2020
First Posted (Actual)
April 15, 2020
Study Record Updates
Last Update Posted (Actual)
April 26, 2022
Last Update Submitted That Met QC Criteria
April 23, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-2020-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Subjective Memory Impairment
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Pusan National University Yangsan HospitalCompletedSubjective Memory ImpairmentKorea, Republic of
-
Ewha Womans UniversityCompletedSubjective Memory ComplaintsKorea, Republic of
-
Hongli ChenNot yet recruitingSubjective Memory Complaint
-
Meir Medical CenterUnknown
-
University of East AngliaUniversity of Illinois at Chicago; Swinburne University of TechnologyUnknownMild Cognitive Impairment | Subjective Memory ImpairmentUnited Kingdom, United States, Australia
-
University of California, San FranciscoUniversity of California, Los Angeles; United States Department of Defense; San...Active, not recruitingMild Cognitive Impairment | Subjective Memory DeclineUnited States
-
Merz Pharmaceuticals GmbHCompletedMemory Disorder | Subjective Cognitive Impairment | Retention Disorder, Cognitive | Memory, Concentration or Attention ProblemsUnited Kingdom, Germany
-
Ewha Womans UniversityCompletedHealthy Adults With Subjective Memory ComplaintsKorea, Republic of
-
Ewha Womans UniversityCompletedHealthy Adults With Subjective Memory ComplaintsKorea, Republic of
-
University of California, San FranciscoFederal University of Minas GeraisCompleted
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