Krill Oil and Muscle Weakness in Type 2 Diabetes (KRIMD)

Dasman Diabetes Institute

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: Vegetable Oil; Dietary Supplement: Krill Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT04943523

RA HM-2021-010

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

vegetable oil 4g/day

Treatment:

Dietary Supplement: Vegetable Oil

Krill Oil

Active Comparator group

Description:

Krill Oil 4g/day

Treatment:

Dietary Supplement: Krill Oil