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The Effect of Omega-3 Supplementation on Muscle Functioning, Inflammation and Muscle Signaling

The Effect of Omega-3 Supplementation on Muscle Functioning, Inflammation and Muscle Signaling in Elderly

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03986307
Enrollment
23
Registered
2019-06-14
Start date
2019-01-01
Completion date
2019-05-25
Last updated
2019-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

muscle metabolism, inflammation, muscle molecular signaling, muscle functioning

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.

Interventions

DIETARY_SUPPLEMENTOmega-3 polyunsaturated fatty acid supplementation

Daily supplementation with omega-3 capsules (daily for 14 weeks). Each day: 3 capsules of 1.1g

OTHERResistance exercise

Resistance exercise training in both supplementation conditions (3 times per week for 12 weeks).

DIETARY_SUPPLEMENTPlacebo - appearance-matched oil supplementation

Daily supplementation with placebo capsules (daily for 14 weeks). Each day: 3 capsules of 1.1g

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Masking description

Subjects are a priori randomized to one of both conditions. Both groups undergo an identical intervention, but receive different supplements (although appearance-matched). The investigators do not know in which condition the subjects are randomized. One researcher, who is not involved in the intervention/data collection/data analyses, holds the code.

Intervention model description

Elderly humans (\>65y) are randomized to a placebo or omega-3 group (interventions, tests, analyses etc. are executed in parallel).

Eligibility

Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Isometric muscle strengthChange in muscle strength between prior to and following the study intervention of 14 weeks (Jan - May 2019)Isometric muscle strength as assessed with Biodex Device in Nm
Systemic inflammatory signalingChange in inflammatory signaling between prior to and following the study intervention of 14 weeks (Jan - May 2019)Systemic (blood) markers of inflammation: hs-CRP (mg/L), IL-6 (pg/mL), TNFa (pg/mL)
Muscle strengthChange in muscle strength between prior to and following the study intervention of 14 weeks (Jan - May 2019)One Repetition Maximum on the leg press fitness device in kg

Secondary

MeasureTime frameDescription
Muscle qualityChange in muscle quality between prior to and following the study intervention of 14 weeks (Jan - May 2019)muscle strength (Torque) per muscle volume
Muscle molecular signaling (Protein levels of anabolic/catabolic signaling and skeletal muscle stress)Change in muscle molecular signaling between prior to and following the study intervention of 14 weeks (Jan - May 2019)Biochemical analyses of muscle biopsies obtained pre-post intervention in both conditions. This involves parameters of muscle anabolism, catabolism, stress, structure, integrity, quality etc.: mTORC1 pathway, FoXO, MAPK (western blotting technique, values expressed as arbitrary units)

Other

MeasureTime frameDescription
Basal metabolic rateChange in basal metabolic rate between prior to and following the study intervention of 14 weeks (Jan - May 2019)Bioelectrical impedance analysis-basal metabolic rate (kcal)
Muscle Volume LeftChange in muscle volume between prior to and following the study intervention of 14 weeks (Jan - May 2019)Muscle Volume in a 2-cm CT-scan slice (4 slices of 5mm)
Handgrip strengthChange in handgrip strength between prior to and following the study intervention of 14 weeks (Jan - May 2019)Handgrip strength measured by a dynamometer (results in kg)
SleepChange in sleep quality between prior to and following the study intervention of 14 weeks (Jan - May 2019)Questionnaire (Pittsburgh Sleep Quality Index)
StressChange inperceived stress between prior to and following the study intervention of 14 weeks (Jan - May 2019)Questionnaire (Perceived Stress Scale)
Mean Muscle Hounsfield UnitChange in Mean Muscle Hounsfield Unit between prior to and following the study intervention of 14 weeks (Jan - May 2019)Muscle Hounsfield Unit serves as a marker of muscle quality
Timed up-and-go testChange in timed up-and-go test performance between prior to and following the study intervention of 14 weeks (Jan - May 2019)Timed-up-and-go: time needed to stand up from a chair, walk 3m, turn, walk back and sit down.
Sit-to-stand testChange in sit-to-stand test performance between prior to and following the study intervention of 14 weeks (Jan - May 2019)Sit-to-stand: the amount of repetitions that one can complete during 30 sec and the time needed to complete 5 sit-to-stands.
Fat%Change in fat% between prior to and following the study intervention of 14 weeks (Jan - May 2019)Bioelectrical impedance analysis-derived fat %
Lean mass%Change in lean mass% between prior to and following the study intervention of 14 weeks (Jan - May 2019)Bioelectrical impedance analysis-derived lean mass %

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026