Krill Oil and Muscle Weakness in Type 2 Diabetes (KRIMD)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Recruiting
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
Krill Oil
Vegetable Oil
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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
Sites / Locations
- Dasman Diabetes InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Krill Oil
Arm Description
vegetable oil 4g/day
Krill Oil 4g/day
Outcomes
Primary Outcome Measures
Grip strength
Change in Grip strength
Secondary Outcome Measures
SPPB
Change in Short performance physical battery test
HbA1c
Change in glycated haemoglobin
Blood pressure
Change in blood pressure
body mass
Change in body mass
Lean mass
Change in lean mass
Body fat
Change in body fat
BMC
Change in bone mineral content
BMD
Change in bone mineral density
Erythrocyte fatty acid profile
Change in Erythrocyte fatty acid profile
Full Information
NCT ID
NCT04943523
First Posted
June 22, 2021
Last Updated
September 10, 2023
Sponsor
Dasman Diabetes Institute
1. Study Identification
Unique Protocol Identification Number
NCT04943523
Brief Title
Krill Oil and Muscle Weakness in Type 2 Diabetes
Acronym
KRIMD
Official Title
Effects of Krill Oil Supplementation on Muscle Mass and Function in People With Muscle Weakness and Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dasman Diabetes Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Group Randomised Controlled Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blind
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
vegetable oil 4g/day
Arm Title
Krill Oil
Arm Type
Active Comparator
Arm Description
Krill Oil 4g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Krill Oil
Intervention Description
Krill oil supplements 4g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Vegetable Oil
Intervention Description
vegetable oil supplements 4g/day
Primary Outcome Measure Information:
Title
Grip strength
Description
Change in Grip strength
Time Frame
Change from baseline to one year
Secondary Outcome Measure Information:
Title
SPPB
Description
Change in Short performance physical battery test
Time Frame
Change from baseline to one year
Title
HbA1c
Description
Change in glycated haemoglobin
Time Frame
Change from baseline to one year
Title
Blood pressure
Description
Change in blood pressure
Time Frame
Change from baseline to one year
Title
body mass
Description
Change in body mass
Time Frame
Change from baseline to one year
Title
Lean mass
Description
Change in lean mass
Time Frame
Change from baseline to one year
Title
Body fat
Description
Change in body fat
Time Frame
Change from baseline to one year
Title
BMC
Description
Change in bone mineral content
Time Frame
Change from baseline to one year
Title
BMD
Description
Change in bone mineral density
Time Frame
Change from baseline to one year
Title
Erythrocyte fatty acid profile
Description
Change in Erythrocyte fatty acid profile
Time Frame
Change from baseline to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stuart R Gray
Phone
01413302569
Email
stuart.gray@glasgow.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebaa AlOzairi
Organizational Affiliation
Dasman Diabetes Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dasman Diabetes Institute
City
Kuwait City
ZIP/Postal Code
15462
Country
Kuwait
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebaa AlOZairi
First Name & Middle Initial & Last Name & Degree
Ebaa AlOzairi
12. IPD Sharing Statement
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Krill Oil and Muscle Weakness in Type 2 Diabetes
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