KRIMD: Krill Oil and Muscle Weakness in Type 2 Diabetes

• Sponsor: Dasman Diabetes Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04943523
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 10

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Dietary Supplement: Krill Oil; Dietary Supplement: Vegetable Oil	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel Group Randomised Controlled TrialParallel Group Randomised Controlled Trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double Blind
• Primary Purpose: Treatment
• Official Title: Effects of Krill Oil Supplementation on Muscle Mass and Function in People With Muscle Weakness and Type 2 Diabetes
• Anticipated Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Grip strength [Change from baseline to one year]

   Change in Grip strength

Secondary Outcome Measures

1. SPPB [Change from baseline to one year]

   Change in Short performance physical battery test

2. HbA1c [Change from baseline to one year]

   Change in glycated haemoglobin

3. Blood pressure [Change from baseline to one year]

   Change in blood pressure

4. body mass [Change from baseline to one year]

   Change in body mass

5. Lean mass [Change from baseline to one year]

   Change in lean mass

6. Body fat [Change from baseline to one year]

   Change in body fat

7. BMC [Change from baseline to one year]

   Change in bone mineral content

8. BMD [Change from baseline to one year]

   Change in bone mineral density

9. Erythrocyte fatty acid profile [Change from baseline to one year]

   Change in Erythrocyte fatty acid profile

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dasman Diabetes Institute	Kuwait City		Kuwait	15462

Sponsors and Collaborators

• Dasman Diabetes Institute

Investigators

• Principal Investigator: Ebaa AlOzairi, Dasman Diabetes Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dasman Diabetes Institute
• ClinicalTrials.gov Identifier: NCT04943523
• Other Study ID Numbers: RA HM-2021-010
• First Posted: Jun 29, 2021
• Last Update Posted: Mar 11, 2022
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Muscle Weakness; Paresis; Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 11, 2022