NCT05869513

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 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

May 5, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

May 11, 2023

Last Update Submit

March 25, 2025

Conditions

Keywords

Home exerciseResistance exerciseExerciseKrill oilMuscle strengthNeuromuscular functionPhysical function

Outcome Measures

Primary Outcomes (1)

  • Nueromuscular Junction (NMJ) transmission instability

    NMJ transmission instability will be measured by iEMG

    Change from baseline to 16 weeks

Secondary Outcomes (7)

  • Knee extensor maximal torque

    Change from baseline to 8 16 weeks

  • 30s chair stand test

    Change from baseline to 16 weeks

  • Gait speed

    Change from baseline to 16 weeks

  • Force steadiness during submaximal isometric knee extensor contractions

    Change from baseline to 16 weeks

  • Red Blood Cell Omega-3 levels

    Change from baseline to 16 weeks

  • +2 more secondary outcomes

Other Outcomes (20)

  • Step Time (sec)

    Change from baseline to 16 weeks

  • Cycle Time (sec)

    Change from baseline to 16 weeks

  • Step Length (cm)

    Change from baseline to16 weeks

  • +17 more other outcomes

Study Arms (2)

Vegetable oil + Resistance exercise

PLACEBO COMPARATOR

4g/day vegetable oil and home based resistance exercise for 16 weeks

Dietary Supplement: Vegetable oilOther: Home-based resistance exercise

Krill oil + Resistance exercise

ACTIVE COMPARATOR

4g/day krill oil and home based resistance exercise for 16 weeks

Dietary Supplement: Krill oilOther: Home-based resistance exercise

Interventions

Vegetable oilDIETARY_SUPPLEMENT

Mixed vegetable oil

Vegetable oil + Resistance exercise
Krill oilDIETARY_SUPPLEMENT

Superba Krill Oil

Krill oil + Resistance exercise

Home based resistance band and body weight exercise

Krill oil + Resistance exerciseVegetable oil + Resistance exercise

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

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 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Glasgow

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

SarcopeniaMotor Activity

Interventions

Plant Oils

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

OilsLipidsPlant PreparationsBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All supplements will be matched for taste and look
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 1:1 parallel group design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 11, 2023

First Posted

May 22, 2023

Study Start

May 5, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations