Back to resultsKrill Oil and Muscle in Older Adults
Primary Purpose
Aging, Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Krill Oil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Aging
Eligibility Criteria
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.
Sites / Locations
- Stuart Robert Gray
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Krill
Arm Description
4g/day of mixed vegetable oil supplements
4g/day krill oil
Outcomes
Primary Outcome Measures
Change in Muscle strength
knee extensor muscle strength
Secondary Outcome Measures
Change in Grip strength
Grip strength
Change in Muscle thickness
Vastus lateralis muscle thickness
Change in Short performance physical battery test
SPPB
Change in Body Fat
Measured by BIA
Change in Lean Mass
Measured by BIA
Change in Fasting glucose
Fasting glucose
Change in Blood lipids
Blood lipids
Change in CRP
CRP
Change in Erythrocyte fatty acid profile
Erythrocyte fatty acid profile
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04048096
Brief Title
Krill Oil and Muscle in Older Adults
Official Title
Effects of Krill Oil Supplementation on Muscle Function in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Sarcopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
4g/day of mixed vegetable oil supplements
Arm Title
Krill
Arm Type
Experimental
Arm Description
4g/day krill oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Krill Oil
Intervention Description
Aker Biomarine Superba Krill Oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Mixed vegetable oil
Primary Outcome Measure Information:
Title
Change in Muscle strength
Description
knee extensor muscle strength
Time Frame
Change from baseline to 6 months
Secondary Outcome Measure Information:
Title
Change in Grip strength
Description
Grip strength
Time Frame
Change from baseline to 6 months
Title
Change in Muscle thickness
Description
Vastus lateralis muscle thickness
Time Frame
Change from baseline to 6 months
Title
Change in Short performance physical battery test
Description
SPPB
Time Frame
Change from baseline to 6 months
Title
Change in Body Fat
Description
Measured by BIA
Time Frame
Change from baseline to 6 months
Title
Change in Lean Mass
Description
Measured by BIA
Time Frame
Change from baseline to 6 months
Title
Change in Fasting glucose
Description
Fasting glucose
Time Frame
Change from baseline to 6 months
Title
Change in Blood lipids
Description
Blood lipids
Time Frame
Change from baseline to 6 months
Title
Change in CRP
Description
CRP
Time Frame
Change from baseline to 6 months
Title
Change in Erythrocyte fatty acid profile
Description
Erythrocyte fatty acid profile
Time Frame
Change from baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Gray, PhD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stuart Robert Gray
City
Glasgow
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35504165
Citation
Alkhedhairi SA, Aba Alkhayl FF, Ismail AD, Rozendaal A, German M, MacLean B, Johnston L, Miller AA, Hunter AM, Macgregor LJ, Combet E, Quinn TJ, Gray SR. The effect of krill oil supplementation on skeletal muscle function and size in older adults: A randomised controlled trial. Clin Nutr. 2022 Jun;41(6):1228-1235. doi: 10.1016/j.clnu.2022.04.007. Epub 2022 Apr 20.
Results Reference
derived
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Krill Oil and Muscle in Older Adults
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