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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986307
• Other study ID #: S61809
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: May 25, 2019

Study information

• Verified date: June 2019
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 25, 2019
• Est. primary completion date: May 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Inflammation

Intervention

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).

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

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	Fat%	Bioelectrical impedance analysis-derived fat %	Change in fat% between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Other	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)
Other	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)
Other	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)
Other	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)
Other	Sleep	Questionnaire (Pittsburgh Sleep Quality Index)	Change in sleep quality between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Other	Stress	Questionnaire (Perceived Stress Scale)	Change inperceived stress between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)