Krill Oil and Muscle Weakness in Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Krill Oil Supplementation on Muscle Mass and Function in People With Muscle Weakness and Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: Krill Oil
* Dietary Supplement: Vegetable Oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Group Randomised Controlled Trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>vegetable oil 4g/day | Dietary Supplement: Vegetable Oil<br>* vegetable oil supplements 4g/day<br>|
| Active Comparator: Krill Oil<br>Krill Oil 4g/day | Dietary Supplement: Krill Oil<br>* Krill oil supplements 4g/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip strength | Change in Grip strength | Change from baseline to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPPB | Change in Short performance physical battery test | Change from baseline to one year | 
| HbA1c | Change in glycated haemoglobin | Change from baseline to one year | 
| Blood pressure | Change in blood pressure | Change from baseline to one year | 
| body mass | Change in body mass | Change from baseline to one year | 
| Lean mass | Change in lean mass | Change from baseline to one year | 
| Body fat | Change in body fat | Change from baseline to one year | 
| BMC | Change in bone mineral content | Change from baseline to one year | 
| BMD | Change in bone mineral density | Change from baseline to one year | 
| Erythrocyte fatty acid profile | Change in Erythrocyte fatty acid profile | Change from baseline to one year |