Clinical trial NCT04943523: Krill Oil and Muscle Weakness in Type 2 Diabetes
Official title: Effects of Krill Oil Supplementation on Muscle Mass and Function in People With Muscle Weakness and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Dasman Diabetes Institute
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Group Randomised Controlled Trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Grip strength
timeFrame: Change from baseline to one year
Secondary outcomes:
measure: SPPB
timeFrame: Change from baseline to one year
measure: HbA1c
timeFrame: Change from baseline to one year
measure: Blood pressure
timeFrame: Change from baseline to one year
measure: body mass
timeFrame: Change from baseline to one year
measure: Lean mass
timeFrame: Change from baseline to one year
measure: Body fat
timeFrame: Change from baseline to one year
measure: BMC
timeFrame: Change from baseline to one year
measure: BMD
timeFrame: Change from baseline to one year
measure: Erythrocyte fatty acid profile
timeFrame: Change from baseline to one year
Other outcomes:
Locations:
city: Kuwait City
country: Kuwait
facility: Dasman Diabetes Institute
Study officials:
affiliation: Dasman Diabetes Institute
name: Ebaa AlOzairi
role: PRINCIPAL_INVESTIGATOR
References: