ClinicalTrials.gg
RecruitingNCT04943523KRIMDUpdated Sep 13, 2023

Krill Oil and Muscle Weakness in Type 2 Diabetes

An interventional study of Krill Oil and Vegetable Oil in Diabetes Mellitus, Type 2, sponsored by Dasman Diabetes Institute. Recruiting at 1 site in Kuwait. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Dasman Diabetes Institute · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started May 2022; still recruiting 4 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 150 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Dasman Diabetes Institute is the lead sponsor of 31 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    vegetable oil 4g/day

    Dietary Supplement: Vegetable Oil

  • Active comparator
    Krill Oil

    Krill Oil 4g/day

    Dietary Supplement: Krill Oil

Interventions

  • Dietary supplementKrill Oil

    Krill oil supplements 4g/day

  • Dietary supplementVegetable Oil

    vegetable oil supplements 4g/day

06

What researchers measure

Primary outcomes

  1. Grip strength

    Change in Grip strength

    Time frame: Change from baseline to one year

Secondary outcomes

  1. SPPB

    Change in Short performance physical battery test

    Time frame: Change from baseline to one year

  2. HbA1c

    Change in glycated haemoglobin

    Time frame: Change from baseline to one year

  3. Blood pressure

    Change in blood pressure

    Time frame: Change from baseline to one year

  4. body mass

    Change in body mass

    Time frame: Change from baseline to one year

  5. Lean mass

    Change in lean mass

    Time frame: Change from baseline to one year

  6. Body fat

    Change in body fat

    Time frame: Change from baseline to one year

  7. BMC

    Change in bone mineral content

    Time frame: Change from baseline to one year

  8. BMD

    Change in bone mineral density

    Time frame: Change from baseline to one year

  9. Erythrocyte fatty acid profile

    Change in Erythrocyte fatty acid profile

    Time frame: Change from baseline to one year

07

Study locations

1 of 1 sites recruiting
  • Dasman Diabetes Institute
    Kuwait City, 15462, Kuwait
    Recruiting
    • Ebaa AlOZairi · Contact
    • Ebaa AlOzairi · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2022 (actual). Primary completion is estimated for Aug 2024, 27 months after the start.

Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 27 months is above that.

Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2021
First posted
Jun 29, 2021
StartActual
May 1, 2022
Primary completionEst.
Aug 2024
CompletionEst.
Aug 2024
Last update
Sep 13, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04943523
Lead sponsor
Dasman Diabetes Institute
Responsible party
Sponsor
First posted
Jun 29, 2021
Start date
May 1, 2022
Primary completion
Aug 2024 (estimated)
Completion
Aug 2024 (estimated)
Last update
Sep 13, 2023

Study contacts

Stuart R Gray
Contact
stuart.gray@glasgow.ac.uk
01413302569
Ebaa AlOzairi
principal investigator · Dasman Diabetes Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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