NCT04048096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

July 26, 2019

Last Update Submit

November 2, 2020

Conditions

AgingSarcopenia

Outcome Measures

Primary Outcomes (1)

  • Change in Muscle strength

    knee extensor muscle strength

    Change from baseline to 6 months

Secondary Outcomes (9)

  • Change in Grip strength

    Change from baseline to 6 months

  • Change in Muscle thickness

    Change from baseline to 6 months

  • Change in Short performance physical battery test

    Change from baseline to 6 months

  • Change in Body Fat

    Change from baseline to 6 months

  • Change in Lean Mass

    Change from baseline to 6 months

  • +4 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

4g/day of mixed vegetable oil supplements

Dietary Supplement: Placebo

Krill

EXPERIMENTAL

4g/day krill oil

Dietary Supplement: Krill Oil

Interventions

Krill OilDIETARY_SUPPLEMENT

Aker Biomarine Superba Krill Oil

Krill
PlaceboDIETARY_SUPPLEMENT

Mixed vegetable oil

Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • BMI less than 35kg/m2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stuart Robert Gray

Glasgow, United Kingdom

Location

Related Publications (2)

  • Hayman O, Alkhedhairi SA, Combet E, Quinn TJ, Hunter AM, Goodall S, Gray SR. Do the effects of krill oil supplementation on skeletal muscle function and size in older adults differ by sex, age or BMI: A secondary analysis of a randomised controlled trial. J Nutr Health Aging. 2026 Jan;30(1):100747. doi: 10.1016/j.jnha.2025.100747. Epub 2025 Dec 3.

    PMID: 41344001DERIVED

  • 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.

    PMID: 35504165DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Stuart Gray, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Exercise and Metabolic Health

Study Record Dates

First Submitted

July 26, 2019

First Posted

August 7, 2019

Study Start

March 7, 2018

Primary Completion

March 10, 2020

Study Completion

March 10, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)