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

Status

Completed

Conditions

Intervention / Treatment

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

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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:

  1. Current use of omega-3 nutritional supplements
  2. Fasting plasma glucose ≥126 mg/dL
  3. Active coronary artery disease
  4. Participation in structured exercise (>3 times per week for 30 minutes or longer)
  5. Smoking
  6. Medications known to affect muscle metabolism (e.g., beta blockers, corticosteroids, tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, anticoagulants)
  7. Renal failure (serum creatinine > 1.5mg/dl)
  8. Chronic active liver disease (Bilirubin > 17mmol/L, AST>144IU/L, or ALT>165IU/L)
  9. Anti-coagulant therapy (warfarin/heparin)
  10. INR >3
  11. Use of systemic glucocorticoids
  12. Chronic use of NSAIDS or aspirin
  13. Pregnancy or breastfeeding
  14. Alcohol consumption greater than 2 glasses/day
  15. Hypothyroidism
  16. 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

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
Skeletal muscle protein synthesis will be measured from the rate of incorporation of infused amino acids measured by mass spectrometry.
Baseline and following 4 months intervention
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.
Baseline and following 4 months intervention

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

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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