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

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Спонсори

KU Leuven

КЛИНИЧНО ИЗСЛЕДВАНЕ: NCT03986307

BioSeek: NCT03986307

Ключови думи

Резюме

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.

Описание

Дати

Последна проверка:	05/31/2019
Първо изпратено:	06/03/2019
Очаквано записване подадено:	06/11/2019
Първо публикувано:	06/13/2019
Изпратена последна актуализация:	06/11/2019
Последна актуализация публикувана:	06/13/2019
Действителна начална дата на проучването:	12/31/2018
Приблизителна дата на първично завършване:	05/24/2019
Очаквана дата на завършване на проучването:	05/24/2019

Състояние или заболяване

Aging

Интервенция / лечение

Dietary Supplement: Omega-3

Other: Resistance exercise

Dietary Supplement: Placebo

Фаза

Групи за ръце

Arm	Интервенция / лечение
Experimental: Omega-3 Elderly supplemented with omega-3.	Dietary Supplement: Omega-3 Daily supplementation with omega-3 capsules (daily for 14 weeks). Each day: 3 capsules of 1.1g
Placebo Comparator: Placebo Elderly supplemented with corn oil.	Dietary Supplement: Placebo Daily supplementation with placebo capsules (daily for 14 weeks). Each day: 3 capsules of 1.1g

Критерии за допустимост

Възрасти, отговарящи на условията за проучване	65 Years Да се 65 Years
Полове, допустими за проучване	All
Приема здрави доброволци	Да
Критерии	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

Резултат

Първични изходни мерки

1. Isometric muscle strength [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 [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 [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

Вторични изходни мерки

1. Muscle quality [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) [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)

Други изходни мерки

1. Handgrip strength [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 [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 [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% [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% [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 [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 [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 [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 [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 [Change inperceived stress between prior to and following the study intervention of 14 weeks (Jan - May 2019)]

Questionnaire (Perceived Stress Scale)