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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: Vegetable Oil; Dietary supplement: Krill Oil

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stuart R Gray; Phone Number: 01413302569; Email: stuart.gray@glasgow.ac.uk

Study Locations

• Kuwait
  • Kuwait City, Kuwait, 15462
    • Recruiting
    • Dasman Diabetes Institute
    • Contact: Ebaa AlOZairi
    • Principal Investigator: Ebaa AlOzairi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; vegetable oil 4g/day	Dietary supplement: Vegetable Oil; vegetable oil supplements 4g/day
Active Comparator: Krill Oil; Krill Oil 4g/day	Dietary supplement: Krill Oil; Krill oil supplements 4g/day

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dasman Diabetes Institute
• Investigators: Principal Investigator: Ebaa AlOzairi, Dasman Diabetes Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Diabetes Mellitus; Diabetes Mellitus, Type 2; Muscle Weakness; Paresis
• Other Study ID Numbers: RA HM-2021-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No