Krill Oil and Muscle Weakness in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— KRIMD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04943523
• Other study ID #: RA HM-2021-010
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Dasman Diabetes Institute
• Contact: Stuart R Gray
• Phone: 01413302569
• Email: stuart.gray[@]glasgow.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Muscle Weakness
• Paresis

Intervention

Dietary Supplement:
• Krill Oil
Krill oil supplements 4g/day
• Vegetable Oil
vegetable oil supplements 4g/day

Locations

Country	Name	City	State
Kuwait	Dasman Diabetes Institute	Kuwait City

Sponsors (1)

Lead Sponsor	Collaborator
Dasman Diabetes Institute

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grip strength	Change in Grip strength	Change from baseline to one year
Secondary	SPPB	Change in Short performance physical battery test	Change from baseline to one year
Secondary	HbA1c	Change in glycated haemoglobin	Change from baseline to one year
Secondary	Blood pressure	Change in blood pressure	Change from baseline to one year
Secondary	body mass	Change in body mass	Change from baseline to one year
Secondary	Lean mass	Change in lean mass	Change from baseline to one year
Secondary	Body fat	Change in body fat	Change from baseline to one year
Secondary	BMC	Change in bone mineral content	Change from baseline to one year
Secondary	BMD	Change in bone mineral density	Change from baseline to one year
Secondary	Erythrocyte fatty acid profile	Change in Erythrocyte fatty acid profile	Change from baseline to one year