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

NCT03986307 | Completed

• 1 other identifier: S61809
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

muscle metabolism; inflammation; muscle molecular signaling; muscle functioning

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Muscle quality

  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)

  Change in muscle molecular signaling between prior to and following the study intervention of 14 weeks (Jan - May 2019)

Other Outcomes (10)

• Handgrip strength

  Change in handgrip strength between prior to and following the study intervention of 14 weeks (Jan - May 2019)

• 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)

• 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)

Study Arms (2)

Omega-3

EXPERIMENTAL

Elderly supplemented with omega-3.

Dietary Supplement: Omega-3 polyunsaturated fatty acid supplementation; Other: Resistance exercise

Placebo

PLACEBO COMPARATOR

Elderly supplemented with corn oil.

Other: Resistance exercise; Dietary Supplement: Placebo - appearance-matched oil supplementation

Interventions

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

Omega-3

Resistance exercise OTHER

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

Omega-3; Placebo

Placebo - appearance-matched oil supplementation DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• aged \>= 65 years

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, 3001, Belgium

Location

MeSH Terms

Conditions

Inflammation

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral researcher

Model Details: Elderly humans (\>65y) are randomized to a placebo or omega-3 group (interventions, tests, analyses etc. are executed in parallel).

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 14, 2019
• Study Start: January 1, 2019
• Primary Completion: May 25, 2019
• Study Completion: May 25, 2019
• Last Updated: June 14, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)