NCT06005064

Brief Summary

This study will determine the effect of 6 months of supplementation with krill oil on muscle strength and mass in middle-aged adults. The study hypothesis is that krill oil supplementation will increase muscle strength and mass in middle-aged adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

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

First Submitted

Initial submission to the registry

August 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

August 16, 2023

Last Update Submit

April 27, 2026

Conditions

Keywords

Krill oilMuscle strengthMuscle massMiddle-aged

Outcome Measures

Primary Outcomes (1)

  • Change in knee extensor maximal isometric torque ( MVC)

    Knee extensor maximal isometric torque measured during a maximal voluntary contraction

    Change from baseline to 24 weeks

Secondary Outcomes (5)

  • Change in fat mass

    Change from baseline to 24 weeks

  • Change in lean mass

    Change from baseline to 24 weeks

  • Change in omega-3 levels

    Change from baseline to 24 weeks

  • Change in Grip strength

    Change from baseline to 24 weeks

  • Change in Muscle thickness

    Change from baseline to 24 weeks

Other Outcomes (3)

  • Change in systemic inflammation

    Change from baseline to 24 weeks

  • Change in muscle inflammation

    Change from baseline to 24 weeks

  • Change in muscle anabolic signalling

    Change from baseline to 24 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Krill oil 4g/day for 24 weeks

Dietary Supplement: Krill oil

Placebo

PLACEBO COMPARATOR

Vegetable oil 4g/day for 24 weeks

Dietary Supplement: Vegetable oil

Interventions

Krill oilDIETARY_SUPPLEMENT

Superba krill oil

Intervention
Vegetable oilDIETARY_SUPPLEMENT

Mixed vegetable oil

Placebo

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be 35-60 years old
  • Have a BMI of less than 35kg/m2

You may not qualify if:

  • People with 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 the ability to perform assessments of muscle function, dementia, on anticoagulant therapy, and/or taking medication known to affect muscle (e.g., steroids).
  • People who have allergies to seafood, and/or regular consumption of more than 1 portion of oily fish per week.
  • People who perform regular (\>1 day/week) resistance exercise training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Glasgow

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Plant Oils

Condition Hierarchy (Ancestors)

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

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
Supplements will be identical in look and taste
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 1:1 basis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 22, 2023

Study Start

November 1, 2023

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations