Krill Oil and Muscle Weakness in Type 2 Diabetes

NCT ID: NCT04943523

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Group Randomised Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double Blind

Study Groups

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Placebo

vegetable oil 4g/day

Group Type PLACEBO_COMPARATOR

Vegetable Oil

Intervention Type DIETARY_SUPPLEMENT

vegetable oil supplements 4g/day

Krill Oil

Krill Oil 4g/day

Group Type ACTIVE_COMPARATOR

Krill Oil

Intervention Type DIETARY_SUPPLEMENT

Krill oil supplements 4g/day

Interventions

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Krill Oil

Krill oil supplements 4g/day

Intervention Type DIETARY_SUPPLEMENT

Vegetable Oil

vegetable oil supplements 4g/day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dasman Diabetes Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ebaa AlOzairi

Role: PRINCIPAL_INVESTIGATOR

Dasman Diabetes Institute

Locations

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Dasman Diabetes Institute

Kuwait City, , Kuwait

Site Status RECRUITING

Countries

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Kuwait

Central Contacts

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Stuart R Gray

Role: CONTACT

01413302569

Facility Contacts

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Ebaa AlOZairi

Role: primary

Other Identifiers

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RA HM-2021-010

Identifier Type: -

Identifier Source: org_study_id

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