Krill Oil and Muscle Weakness in Type 2 Diabetes

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Vegetable Oil; Dietary Supplement: Krill Oil

• Registration Number: NCT04943523
• Lead Sponsor: Dasman Diabetes Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-29
• Study Start: 2022-05-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-09-10
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Vegetable Oil	vegetable oil 4g/day
Krill Oil	Krill Oil	Krill Oil 4g/day

Primary Outcome Measures

Name	Time	Method
Grip strength	Change from baseline to one year	Change in Grip strength

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dasman Diabetes Institute; 🇰🇼 Kuwait City, Kuwait