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

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Dietary supplement: Omega-3 polyunsaturated fatty acid supplementation; Other: Resistance exercise; Dietary supplement: Placebo - appearance-matched oil supplementation

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3001
    • KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle quality	muscle strength (Torque) per muscle volume	Change in muscle quality between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Muscle molecular signaling (Protein levels of anabolic/catabolic signaling and skeletal muscle stress)	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)	Change in muscle molecular signaling between prior to and following the study intervention of 14 weeks (Jan - May 2019)

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): May 25, 2019
• Study Completion (ACTUAL): May 25, 2019

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (ACTUAL): June 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: inflammation; muscle metabolism; muscle molecular signaling; muscle functioning
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: S61809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No