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

Primary Purpose

Aging

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Omega-3 polyunsaturated fatty acid supplementation
Resistance exercise
Placebo - appearance-matched oil supplementation
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Aging focused on measuring muscle metabolism, inflammation, muscle molecular signaling, muscle functioning

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • KU Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Omega-3

Placebo

Arm Description

Elderly supplemented with omega-3.

Elderly supplemented with corn oil.

Outcomes

Primary Outcome Measures

Isometric muscle strength
Isometric muscle strength as assessed with Biodex Device in Nm
Systemic inflammatory signaling
Systemic (blood) markers of inflammation: hs-CRP (mg/L), IL-6 (pg/mL), TNFa (pg/mL)
Muscle strength
One Repetition Maximum on the leg press fitness device in kg

Secondary Outcome Measures

Muscle quality
muscle strength (Torque) per muscle volume
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)

Full Information

First Posted
June 4, 2019
Last Updated
June 12, 2019
Sponsor
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT03986307
Brief Title
The Effect of Omega-3 Supplementation on Muscle Functioning, Inflammation and Muscle Signaling
Official Title
The Effect of Omega-3 Supplementation on Muscle Functioning, Inflammation and Muscle Signaling in Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
May 25, 2019 (Actual)
Study Completion Date
May 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging
Keywords
muscle metabolism, inflammation, muscle molecular signaling, muscle functioning

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Elderly humans (>65y) are randomized to a placebo or omega-3 group (interventions, tests, analyses etc. are executed in parallel).
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3
Arm Type
Experimental
Arm Description
Elderly supplemented with omega-3.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Elderly supplemented with corn oil.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 polyunsaturated fatty acid supplementation
Intervention Description
Daily supplementation with omega-3 capsules (daily for 14 weeks). Each day: 3 capsules of 1.1g
Intervention Type
Other
Intervention Name(s)
Resistance exercise
Intervention Description
Resistance exercise training in both supplementation conditions (3 times per week for 12 weeks).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo - appearance-matched oil supplementation
Intervention Description
Daily supplementation with placebo capsules (daily for 14 weeks). Each day: 3 capsules of 1.1g
Primary Outcome Measure Information:
Title
Isometric muscle strength
Description
Isometric muscle strength as assessed with Biodex Device in Nm
Time Frame
Change in muscle strength between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Title
Systemic inflammatory signaling
Description
Systemic (blood) markers of inflammation: hs-CRP (mg/L), IL-6 (pg/mL), TNFa (pg/mL)
Time Frame
Change in inflammatory signaling between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Title
Muscle strength
Description
One Repetition Maximum on the leg press fitness device in kg
Time Frame
Change in muscle strength between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Secondary Outcome Measure Information:
Title
Muscle quality
Description
muscle strength (Torque) per muscle volume
Time Frame
Change in muscle quality between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Title
Muscle molecular signaling (Protein levels of anabolic/catabolic signaling and skeletal muscle stress)
Description
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)
Time Frame
Change in muscle molecular signaling between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Other Pre-specified Outcome Measures:
Title
Handgrip strength
Description
Handgrip strength measured by a dynamometer (results in kg)
Time Frame
Change in handgrip strength between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Title
Timed up-and-go test
Description
Timed-up-and-go: time needed to stand up from a chair, walk 3m, turn, walk back and sit down.
Time Frame
Change in timed up-and-go test performance between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Title
Sit-to-stand test
Description
Sit-to-stand: the amount of repetitions that one can complete during 30 sec and the time needed to complete 5 sit-to-stands.
Time Frame
Change in sit-to-stand test performance between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Title
Fat%
Description
Bioelectrical impedance analysis-derived fat %
Time Frame
Change in fat% between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Title
Lean mass%
Description
Bioelectrical impedance analysis-derived lean mass %
Time Frame
Change in lean mass% between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Title
Basal metabolic rate
Description
Bioelectrical impedance analysis-basal metabolic rate (kcal)
Time Frame
Change in basal metabolic rate between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Title
Muscle Volume Left
Description
Muscle Volume in a 2-cm CT-scan slice (4 slices of 5mm)
Time Frame
Change in muscle volume between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Title
Mean Muscle Hounsfield Unit
Description
Muscle Hounsfield Unit serves as a marker of muscle quality
Time Frame
Change in Mean Muscle Hounsfield Unit between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Title
Sleep
Description
Questionnaire (Pittsburgh Sleep Quality Index)
Time Frame
Change in sleep quality between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Title
Stress
Description
Questionnaire (Perceived Stress Scale)
Time Frame
Change inperceived stress between prior to and following the study intervention of 14 weeks (Jan - May 2019)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
KU Leuven
City
Leuven
ZIP/Postal Code
3001
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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

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