SarcopeniaPhase 1NCT02103842
Omega-3 Fatty Acids to Combat Sarcopenia
A Phase 1 study testing Omega-3 fatty acids in people with Sarcopenia, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine how omega-3 fatty acids influence muscle protein metabolism and mitochondrial physiology in the context of human aging. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Omega-3 fatty acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jul 2015
- Phase
- Phase 1
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-35 or 65-85 years
Who cannot join
- Current use of omega-3 nutritional supplements
- Fasting plasma glucose ≥126 mg/dL
- Active coronary artery disease
- Participation in structured exercise (>3 times per week for 30 minutes or longer)
- Smoking
- Medications known to affect muscle metabolism (e.g., beta blockers, corticosteroids, tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, anticoagulants)
Show all 16Show fewer
- Renal failure (serum creatinine > 1.5mg/dl)
- Chronic active liver disease (Bilirubin > 17mmol/L, AST>144IU/L, or ALT>165IU/L)
- Anti-coagulant therapy (warfarin/heparin)
- INR >3
- Use of systemic glucocorticoids
- Chronic use of NSAIDS or aspirin
- Pregnancy or breastfeeding
- Alcohol consumption greater than 2 glasses/day
- Hypothyroidism
- Fish or shellfish allergy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine how omega-3 fatty acids influence muscle protein metabolism and mitochondrial physiology in the context of human aging.
- Conditions
- Sarcopenia
- Being tested
- Omega-3 fatty acids
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidsDrug
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 fatty acids | Experimental | Participants will take 3.9g/day of Eicosapentaenoic acid and docosahexaenoic acid for 4 months Receives: Drug: Omega-3 fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle protein synthesis
Skeletal muscle protein synthesis will be measured from the rate of incorporation of infused amino acids measured by mass spectrometry.
Measured: Baseline and following 4 months intervention
Change in Muscle mitochondrial function
Mitochondrial function will be measured in isolated mitochondria by high-resolution respirometry.
Measured: Baseline and following 4 months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian R. Lanza, Mayo Clinic
- Investigators
- Ian R Lanza, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103842
- Sponsor's protocol ID
- 14-000639
- Status last verified
- Dec 2015
- First submitted
- 18 Mar 2014
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids to Combat Sarcopenia
- ClinicalTrials.gov ID
- NCT02103842
- Acronym / sponsor ID
- 14-000639
- Conditions
- Sarcopenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Apr 2014 (estimated)
- 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.
The purpose of this study is to determine how omega-3 fatty acids influence muscle protein metabolism and mitochondrial physiology in the context of human aging.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omega-3 fatty acids | Experimental | Drug: Omega-3 fatty acidsParticipants will take 3.9g/day of Eicosapentaenoic acid and docosahexaenoic acid for 4 months |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-35 or 65-85 years
Key exclusion criteria (16 listed)
- Current use of omega-3 nutritional supplements
- Fasting plasma glucose ≥126 mg/dL
- Active coronary artery disease
- Participation in structured exercise (>3 times per week for 30 minutes or longer)
- Smoking
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 fatty acids | Drug | Omega-3 fatty acids |
Primary outcome
Change in Muscle protein synthesis
Time frame: Baseline and following 4 months intervention
Skeletal muscle protein synthesis will be measured from the rate of incorporation of infused amino acids measured by mass spectrometry.
Change in Muscle mitochondrial function
Time frame: Baseline and following 4 months intervention
Mitochondrial function will be measured in isolated mitochondria by high-resolution respirometry.
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 24 Dec 2015.
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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.
Ian R Lanza, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omega-3 fatty acids in people with Sarcopenia, run by Mayo Clinic at 1 site in United States.
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 16 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 24 Dec 2015. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Muscle protein synthesis (time frame: Baseline and following 4 months intervention). The study lists 2 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 24 Dec 2015.