Clinical trial NCT03986307: The Effect of Omega-3 Supplementation on Muscle Functioning, Inflammation and Muscle Signaling
Official title: The Effect of Omega-3 Supplementation on Muscle Functioning, Inflammation and Muscle Signaling in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: muscle metabolism
inflammation
muscle molecular signaling
muscle functioning
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 23
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Elderly humans (\>65y) are randomized to a placebo or omega-3 group (interventions, tests, analyses etc. are executed in parallel).
Primary purpose: BASIC_SCIENCE

Brief summary: Elderly are supplemented with either Omega-3 (3 x 1.1g per day) or placebo (corn oil) during 14 weeks. The last 12 weeks, supplementation is combined with resistance exercise training (3x per week) focusing on upper leg strength. In the present project, the investigators study whether differences in muscle strength and/or muscle mass between conditions can be explained by omega-3-induced effects on systemic or muscle inflammatory signaling, or differences in muscle molecular signaling.

Detailed description: Elderly are supplemented with either Omega-3 (3 x 1.1g per day) or placebo (corn oil) during 14 weeks. The last 12 weeks, supplementation is combined with resistance exercise training (3x per week) focusing on upper leg strength. In the present project, the investigators study whether differences in muscle strength and/or muscle mass between conditions can be explained by omega-3-induced effects on systemic or muscle inflammatory signaling, or differences in muscle molecular signaling.

Eligibility criteria: Inclusion Criteria:

* aged \>= 65 years

Exclusion Criteria:

* BMI \< 20; BMI \> 35
* regular NSAID intake in the last 3 months
* omega-3 supplementation in the last year
* regular resistance exercise in the last year
* cancer, liver and renal disease, unstable cardiovascular disease, musculoskeletal disease
* cognitive limitations that might interfere with the (adherence to) the intervention or with the testing of outcome parameters
* unstable body weight
* smoking

Primary outcomes:
measure: Isometric muscle strength
timeFrame: Change in muscle strength between prior to and following the study intervention of 14 weeks (Jan - May 2019)
measure: Systemic inflammatory signaling
timeFrame: Change in inflammatory signaling between prior to and following the study intervention of 14 weeks (Jan - May 2019)
measure: Muscle strength
timeFrame: Change in muscle strength between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Secondary outcomes:
measure: Muscle quality
timeFrame: Change in muscle quality between prior to and following the study intervention of 14 weeks (Jan - May 2019)
measure: Muscle molecular signaling (Protein levels of anabolic/catabolic signaling and skeletal muscle stress)
timeFrame: Change in muscle molecular signaling between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Other outcomes:
measure: Handgrip strength
timeFrame: Change in handgrip strength between prior to and following the study intervention of 14 weeks (Jan - May 2019)
measure: Timed up-and-go test
timeFrame: Change in timed up-and-go test performance between prior to and following the study intervention of 14 weeks (Jan - May 2019)
measure: Sit-to-stand test
timeFrame: Change in sit-to-stand test performance between prior to and following the study intervention of 14 weeks (Jan - May 2019)
measure: Fat%
timeFrame: Change in fat% between prior to and following the study intervention of 14 weeks (Jan - May 2019)
measure: Lean mass%
timeFrame: Change in lean mass% between prior to and following the study intervention of 14 weeks (Jan - May 2019)
measure: Basal metabolic rate
timeFrame: Change in basal metabolic rate between prior to and following the study intervention of 14 weeks (Jan - May 2019)
measure: Muscle Volume Left
timeFrame: Change in muscle volume between prior to and following the study intervention of 14 weeks (Jan - May 2019)
measure: Mean Muscle Hounsfield Unit
timeFrame: Change in Mean Muscle Hounsfield Unit between prior to and following the study intervention of 14 weeks (Jan - May 2019)
measure: Sleep
timeFrame: Change in sleep quality between prior to and following the study intervention of 14 weeks (Jan - May 2019)
measure: Stress
timeFrame: Change inperceived stress between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
References: