Effect of Krill Oil on Cognitive Function in Adults

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Subjective Memory Impairment

Intervention / Treatment
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* Dietary Supplement: Krill oil group
* Dietary Supplement: Placebo group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Krill oil group<br>This group takes Krill oil for 12 weeks | Dietary Supplement: Krill oil group<br>* This group takes 500 mg/day Krill oil for 12 weeks.<br>|
| Placebo Comparator: Placebo group<br>This group takes Placebo for 12 weeks | Dietary Supplement: Placebo group<br>* This group takes 500 mg/day Placebo for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| brain derived neurotrophic factor | Change in brain derived neurotrophic factor level during 3 months | Change in brain derived neurotrophic factor level during 3 months |