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

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ClinicalTrials.gov Identifier: NCT03986307
Recruitment Status : Completed
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
sebastiaan dalle, KU Leuven

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.

Condition or disease Intervention/treatment Phase
Aging Dietary Supplement: Omega-3 polyunsaturated fatty acid supplementation Other: Resistance exercise Dietary Supplement: Placebo - appearance-matched oil supplementation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Elderly humans (>65y) are randomized to a placebo or omega-3 group (interventions, tests, analyses etc. are executed in parallel).
Masking: Double (Participant, 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.
Primary Purpose: Basic Science
Official Title: The Effect of Omega-3 Supplementation on Muscle Functioning, Inflammation and Muscle Signaling in Elderly
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : May 25, 2019
Actual Study Completion Date : May 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Omega-3
Elderly supplemented with omega-3.
Dietary Supplement: Omega-3 polyunsaturated fatty acid supplementation
Daily supplementation with omega-3 capsules (daily for 14 weeks). Each day: 3 capsules of 1.1g

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

Placebo Comparator: Placebo
Elderly supplemented with corn oil.
Other: Resistance exercise
Resistance exercise training in both supplementation conditions (3 times per week for 12 weeks).

Dietary Supplement: Placebo - appearance-matched oil supplementation
Daily supplementation with placebo capsules (daily for 14 weeks). Each day: 3 capsules of 1.1g




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986307


Locations
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Belgium
KU Leuven
Leuven, Belgium, 3001
Sponsors and Collaborators
KU Leuven

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Responsible Party: sebastiaan dalle, Doctoral researcher, KU Leuven
ClinicalTrials.gov Identifier: NCT03986307     History of Changes
Other Study ID Numbers: S61809
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by sebastiaan dalle, KU Leuven:
muscle metabolism
inflammation
muscle molecular signaling
muscle functioning

Additional relevant MeSH terms:
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Inflammation
Pathologic Processes