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Completed

NCT Number: NCT03986307

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

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.

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Key information

Conditions

Aging Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven

Leuven, 3001, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 polyunsaturated fatty acid supplementation

Dietary Supplement

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

Resistance Exercise

Other

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

Placebo - appearance-matched oil supplementation

Dietary Supplement

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

Primary outcomes

  1. Isometric muscle strength

    Time frame: Change 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

  2. Systemic inflammatory signaling

    Time frame: Change 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)

  3. Muscle strength

    Time frame: Change 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 outcomes

  1. Muscle quality

    Time frame: Change in muscle quality between prior to and following the study intervention of 14 weeks (Jan - May 2019)

    muscle strength (Torque) per muscle volume

  2. Muscle molecular signaling (Protein levels of anabolic/catabolic signaling and skeletal muscle stress)

    Time frame: 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 outcomes

  1. Handgrip strength

    Time frame: Change 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)

  2. Timed up-and-go test

    Time frame: Change 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.

  3. Sit-to-stand test

    Time frame: Change 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.

  4. Fat%

    Time frame: Change in fat% between prior to and following the study intervention of 14 weeks (Jan - May 2019)

    Bioelectrical impedance analysis-derived fat %

  5. Lean mass%

    Time frame: Change in lean mass% between prior to and following the study intervention of 14 weeks (Jan - May 2019)

    Bioelectrical impedance analysis-derived lean mass %

  6. Basal metabolic rate

    Time frame: Change 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)

  7. Muscle Volume Left

    Time frame: Change 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)

  8. Mean Muscle Hounsfield Unit

    Time frame: Change 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

  9. Sleep

    Time frame: Change in sleep quality between prior to and following the study intervention of 14 weeks (Jan - May 2019)

    Questionnaire (Pittsburgh Sleep Quality Index)

  10. Stress

    Time frame: Change inperceived stress between prior to and following the study intervention of 14 weeks (Jan - May 2019)

    Questionnaire (Perceived Stress Scale)

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2019
Registry last updated
Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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