- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02103842
Omega-3 Fatty Acids to Combat Sarcopenia
December 22, 2015 updated by: Ian R. Lanza, Mayo Clinic
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 Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18-35 or 65-85 years
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Omega-3 fatty acids
Participants will take 3.9g/day of Eicosapentaenoic acid and docosahexaenoic acid for 4 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Muscle protein synthesis
Time Frame: Baseline and following 4 months intervention
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Skeletal muscle protein synthesis will be measured from the rate of incorporation of infused amino acids measured by mass spectrometry.
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Baseline and following 4 months intervention
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Change in Muscle mitochondrial function
Time Frame: Baseline and following 4 months intervention
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Mitochondrial function will be measured in isolated mitochondria by high-resolution respirometry.
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Baseline and following 4 months intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ian R Lanza, PhD, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
March 18, 2014
First Submitted That Met QC Criteria
April 1, 2014
First Posted (Estimate)
April 4, 2014
Study Record Updates
Last Update Posted (Estimate)
December 24, 2015
Last Update Submitted That Met QC Criteria
December 22, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-000639
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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