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

NCT ID: NCT03986307

Last Updated: 2019-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-05-25

Brief Summary

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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.

Detailed Description

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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

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Omega-3

Elderly supplemented with omega-3.

Group Type EXPERIMENTAL

Omega-3 polyunsaturated fatty acid supplementation

Intervention Type DIETARY_SUPPLEMENT

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

Resistance exercise

Intervention Type OTHER

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

Placebo

Elderly supplemented with corn oil.

Group Type PLACEBO_COMPARATOR

Resistance exercise

Intervention Type OTHER

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

Placebo - appearance-matched oil supplementation

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Omega-3 polyunsaturated fatty acid supplementation

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

Intervention Type DIETARY_SUPPLEMENT

Resistance exercise

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

Intervention Type OTHER

Placebo - appearance-matched oil supplementation

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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sebastiaan dalle

Doctoral researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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KU Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S61809

Identifier Type: -

Identifier Source: org_study_id

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