NCT04943523

Brief Summary

The age-related loss of muscle mass and function, sarcopenia, has several deleterious effects, such as a reduction in the quality of life and an increase in the incidence of falls, often leading to hospitalisation. The prevalence of sarcopenia is unclear but is estimated to be between 4.6 and 7.9% and the loss of skeletal muscle mass and function is accelerated in people with type 2 diabetes. With the percentage of older people and the percentage of people with type 2 diabetes predicted to rise in coming years it is crucial to develop therapies to increase muscle mass and function. Alterations in nutrition have also been suggested to be of therapeutic use in sarcopenia. Epidemiological data showed that the consumption of fatty fish is positively associated with muscle function in older population, indicating a potential role for long-chain n-3 polyunsaturated fatty acids (LCn-3 PUFA) in increasing muscle mass and function in older people. The aim of the current study, therefore, is to determine the effects of krill oil supplementation on muscle size and function in adults with muscle weakness and type 2 diabetes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started May 2022

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

September 13, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

June 22, 2021

Last Update Submit

September 10, 2023

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Grip strength

    Change in Grip strength

    Change from baseline to one year

Secondary Outcomes (9)

  • SPPB

    Change from baseline to one year

  • HbA1c

    Change from baseline to one year

  • Blood pressure

    Change from baseline to one year

  • body mass

    Change from baseline to one year

  • Lean mass

    Change from baseline to one year

  • +4 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

vegetable oil 4g/day

Dietary Supplement: Vegetable Oil

Krill Oil

ACTIVE COMPARATOR

Krill Oil 4g/day

Dietary Supplement: Krill Oil

Interventions

Krill OilDIETARY_SUPPLEMENT

Krill oil supplements 4g/day

Krill Oil
Vegetable OilDIETARY_SUPPLEMENT

vegetable oil supplements 4g/day

Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physician confirmed type 2 diabetes.
  • Age \>/= 40 years
  • No changes in anti-diabetic medication in the last 3 months.
  • Muscle weakness (grip strength \<27kg and females \<16kg)

You may not qualify if:

  • BMI of 45 or higher
  • BP of 160/100mmHg or higher
  • Cancer or cancer that has been in remission \<5 years
  • Any medical condition that prevents participants from exercising safely
  • On anticoagulant therapy
  • Allergies to seafood
  • Regular consumption of more than 2 portions of oily fish per week
  • Currently consuming omega-3 supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dasman Diabetes Institute

Kuwait City, 15462, Kuwait

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Plant Oils

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

OilsLipidsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Ebaa AlOzairi

    Dasman Diabetes Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stuart R Gray

CONTACT

01413302569stuart.gray@glasgow.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Group Randomised Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2021

First Posted

June 29, 2021

Study Start

May 1, 2022

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

September 13, 2023

Record last verified: 2023-07

Locations

KU(1)