Krill Oil and Resistance Exercise in Older Adults (KOREA)

March 25, 2025 updated by: Stuart Gray, University of Glasgow

The Effects of Krill Oil Supplementation on Adaptations in Muscle Strength, Function, Mass and Neuromuscular Function to a Pragmatic Home-based Resistance Exercise Intervention in Sedentary Older Adults: a Randomised Controlled Trial

The aim of this study is to determine whether krill oil supplementation enhances effects of a pragmatic resistance exercise programme on adaptations in muscle strength, mass, function and neuromuscular function in sedentary older adults. Hypothesis - krill oil supplementation will enhance the beneficial effects of resistance exercise on muscle strength, function, mass and neuromuscular function in sedentary older adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Over the age of 60 years
  • scoring a low level of physical activity based on international physical activity questionnaire (not meeting the recommend physical activity which is at least 600 MET-min per week).

Exclusion Criteria:

  • Diabetes
  • severe cardiovascular disease
  • seizure disorders
  • uncontrolled hypertension (>150/90mmHg at baseline measurement)
  • cancer or cancer that has been in remission <5 years
  • ambulatory impairments which would limit ability to perform assessments of muscle function
  • dementia
  • taking medication known to affect muscle (e.g. steroids)
  • have an implanted electronic device (e.g. pacemaker/defibrillator/insulin pump)
  • on anticoagulant therapy
  • allergies to seafood
  • regular consumption of more than 1 portion of oily fish per week
  • already taking fish or krill oil or other n3 PUFA supplements
  • femoral neck fracture or other severe of hip or knee operations
  • stroke
  • Parkinson's disease
  • COPD
  • kidney disease
  • hyperlipidaemia
  • obesity
  • osteoporosis.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Vegetable oil + Resistance exercise
4g/day vegetable oil and home based resistance exercise for 16 weeks
Dietary supplement: Vegetable oil
Mixed vegetable oil
Other: Home-based resistance exercise
Home based resistance band and body weight exercise
Active Comparator: Krill oil + Resistance exercise
4g/day krill oil and home based resistance exercise for 16 weeks
Other: Home-based resistance exercise
Home based resistance band and body weight exercise
Dietary supplement: Krill oil
Superba Krill Oil

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Nueromuscular Junction (NMJ) transmission instability
Time Frame: Change from baseline to 16 weeks
NMJ transmission instability will be measured by iEMG
Change from baseline to 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knee extensor maximal torque
Time Frame: Change from baseline to 8 16 weeks
Knee extensor maximal torque will be measured by a load cell
Change from baseline to 8 16 weeks
30s chair stand test
Time Frame: Change from baseline to 16 weeks
measuring the functional abilities
Change from baseline to 16 weeks
Gait speed
Time Frame: Change from baseline to 16 weeks
measuring the functional abilities
Change from baseline to 16 weeks
Force steadiness during submaximal isometric knee extensor contractions
Time Frame: Change from baseline to 16 weeks
Steadiness of force whilst contracting
Change from baseline to 16 weeks
Red Blood Cell Omega-3 levels
Time Frame: Change from baseline to 16 weeks
Change from baseline to 16 weeks
Grip strength
Time Frame: Change from baseline to 16 weeks
Grip strength will be measured by handgrip dynamometer
Change from baseline to 16 weeks
Muscle thickness
Time Frame: Change from baseline to 16 weeks
Vastus Lateralis muscle thickness will be measured by ultrasound
Change from baseline to 16 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Single Support (%GC)
Time Frame: Change from baseline to 16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to 16 weeks
Double Support (%GC)
Time Frame: Change from baseline to 16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to 16 weeks
Swing (%GC)
Time Frame: Change from baseline to 16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to 16 weeks
Stance (%GC)
Time Frame: Change from baseline to 16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to 16 weeks
Step/ Extremity Ratio
Time Frame: Change from baseline to 16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to 16 weeks
Number of Steps
Time Frame: Change from baseline to 16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to 16 weeks
Cadence (Steps/Min)
Time Frame: Change from baseline to 16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to 16 weeks
Step Time (sec)
Time Frame: Change from baseline to 16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to 16 weeks
Cycle Time (sec)
Time Frame: Change from baseline to 16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to 16 weeks
Step Length (cm)
Time Frame: Change from baseline to16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to16 weeks
Stride Length (cm)
Time Frame: Change from baseline to16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to16 weeks
H-H Base Support (cm)
Time Frame: Change from baseline to 16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to 16 weeks
Toe In / Out (deg)
Time Frame: Change from baseline to 16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to 16 weeks
Distance (cm)
Time Frame: Change from baseline to 16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to 16 weeks
Ambulation Time (sec)
Time Frame: Change from baseline to 16 weeks
Change from baseline to 16 weeks
Velocity (cm/sec)
Time Frame: Change from baseline to 16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to 16 weeks
Mean Normalized Velocity
Time Frame: Change from baseline to16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to16 weeks
Step Time Differential (sec)
Time Frame: Change from baseline to 16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to 16 weeks
Step Length Differential (cm)
Time Frame: Change from baseline to 16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to 16 weeks
Cycle Time Differential (sec)
Time Frame: Change from baseline to 16 weeks
Measured during a 4m walk using a gaitrite mat
Change from baseline to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Glasgow

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KOREA

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

product manufactured in and exported from the U.S.

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.

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