AgingNCT03986307
The Effect of Omega-3 Supplementation on Muscle Functioning, Inflammation and Muscle Signaling
A study testing Omega-3 polyunsaturated fatty acid supplementation and Resistance exercise in people with Aging, run by KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Omega-3 polyunsaturated fatty acid supplementation and Resistance exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2019to 25 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- aged >= 65 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Omega-3 Supplementation on Muscle Functioning, Inflammation and Muscle Signaling in Elderly
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Omega-3 polyunsaturated fatty acid supplementation, Resistance exercise, Placebo - appearance-matched oil supplementation
- Keywords
- muscle metabolism, inflammation, muscle molecular signaling, muscle functioning
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 polyunsaturated fatty acid supplementationDietary supplement
Daily supplementation with omega-3 capsules (daily for 14 weeks). Each day: 3 capsules of 1.1g
Resistance exerciseOther
Resistance exercise training in both supplementation conditions (3 times per week for 12 weeks).
Placebo - appearance-matched oil supplementationDietary supplement
Daily supplementation with placebo capsules (daily for 14 weeks). Each day: 3 capsules of 1.1g
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Experimental | Elderly supplemented with omega-3. Receives: Dietary Supplement: Omega-3 polyunsaturated fatty acid supplementation; Other: Resistance exercise |
| Placebo | Placebo comparator | Elderly supplemented with corn oil. Receives: Other: Resistance exercise; Dietary Supplement: Placebo - appearance-matched oil supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric muscle strength
Isometric muscle strength as assessed with Biodex Device in Nm
Measured: 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)
Measured: 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
Measured: Change in muscle strength between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Secondary outcomes (2)
Muscle quality
muscle strength (Torque) per muscle volume
Measured: 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)
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)
Measured: Change in muscle molecular signaling between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Jan 2019
- Primary completion25 May 2019
- Study completion25 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Elderly humans (\>65y) are randomized to a placebo or omega-3 group (interventions, tests, analyses etc. are executed in parallel).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sebastiaan dalle, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986307
- Sponsor's protocol ID
- S61809
- Status last verified
- Jun 2019
- First submitted
- 4 Jun 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Omega-3 Supplementation on Muscle Functioning, Inflammation and Muscle Signaling in Elderly
- ClinicalTrials.gov ID
- NCT03986307
- Acronym / sponsor ID
- S61809
- Conditions
- Aging
- Keywords
- muscle metabolism, inflammation, muscle molecular signaling, muscle functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 25 May 2019 (actual)
- Study completion
- 25 May 2019 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Elderly humans (>65y) are randomized to a placebo or omega-3 group (interventions, tests, analyses etc. are executed in parallel).
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Experimental | Dietary Supplement: Omega-3 polyunsaturated fatty acid supplementation, Other: Resistance exerciseElderly supplemented with omega-3. |
| Placebo | Placebo comparator | Other: Resistance exercise, Dietary Supplement: Placebo - appearance-matched oil supplementationElderly supplemented with corn oil. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- aged >= 65 years
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 polyunsaturated fatty acid supplementationDaily supplementation with omega-3 capsules (daily for 14 weeks). Each day: 3 capsules of 1.1g | Dietary supplement | Omega-3 |
| Resistance exerciseResistance exercise training in both supplementation conditions (3 times per week for 12 weeks). | Other | Omega-3, Placebo |
| Placebo - appearance-matched oil supplementationDaily supplementation with placebo capsules (daily for 14 weeks). Each day: 3 capsules of 1.1g | Dietary supplement | Placebo |
Primary outcome
Isometric muscle strength
Time frame: 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
Systemic inflammatory signaling
Time frame: 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)
Muscle strength
Time frame: 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
2 secondary outcomes
Muscle quality
Time frame: 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)
Time frame: Change in muscle molecular signaling between prior to and following the study intervention of 14 weeks (Jan - May 2019)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 polyunsaturated fatty acid supplementation and Resistance exercise in people with Aging, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric muscle strength (time frame: Change in muscle strength between prior to and following the study intervention of 14 weeks (Jan - May 2019)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.