- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04048096
Krill Oil and Muscle in Older Adults
November 2, 2020 updated by: Stuart Gray, University of Glasgow
Effects of Krill Oil Supplementation on Muscle Function in Older Adults
The aim of this study is to determine the effects of krill oil supplementation on muscle mass in function in older adults.
Half of the participants will receive krill oil supplements and the other half a placebo.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
102
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
-
-
-
Glasgow, United Kingdom
- Stuart Robert Gray
-
-
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
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI less than 35kg/m2
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 2 portions of oily fish per week.
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
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
4g/day of mixed vegetable oil supplements
|
Mixed vegetable oil
|
EXPERIMENTAL: Krill
4g/day krill oil
|
Aker Biomarine Superba Krill Oil
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Muscle strength
Time Frame: Change from baseline to 6 months
|
knee extensor muscle strength
|
Change from baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Grip strength
Time Frame: Change from baseline to 6 months
|
Grip strength
|
Change from baseline to 6 months
|
Change in Muscle thickness
Time Frame: Change from baseline to 6 months
|
Vastus lateralis muscle thickness
|
Change from baseline to 6 months
|
Change in Short performance physical battery test
Time Frame: Change from baseline to 6 months
|
SPPB
|
Change from baseline to 6 months
|
Change in Body Fat
Time Frame: Change from baseline to 6 months
|
Measured by BIA
|
Change from baseline to 6 months
|
Change in Lean Mass
Time Frame: Change from baseline to 6 months
|
Measured by BIA
|
Change from baseline to 6 months
|
Change in Fasting glucose
Time Frame: Change from baseline to 6 months
|
Fasting glucose
|
Change from baseline to 6 months
|
Change in Blood lipids
Time Frame: Change from baseline to 6 months
|
Blood lipids
|
Change from baseline to 6 months
|
Change in CRP
Time Frame: Change from baseline to 6 months
|
CRP
|
Change from baseline to 6 months
|
Change in Erythrocyte fatty acid profile
Time Frame: Change from baseline to 6 months
|
Erythrocyte fatty acid profile
|
Change from baseline to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stuart Gray, PhD, University of Glasgow
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)
March 7, 2018
Primary Completion (ACTUAL)
March 10, 2020
Study Completion (ACTUAL)
March 10, 2020
Study Registration Dates
First Submitted
July 26, 2019
First Submitted That Met QC Criteria
August 5, 2019
First Posted (ACTUAL)
August 7, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 3, 2020
Last Update Submitted That Met QC Criteria
November 2, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200170067
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.
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