Omega-3 Fatty Acids to Combat Sarcopenia

Sarcopenia Clinical Trial

Official title:

Omega-3 Fatty Acids to Combat Sarcopenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103842
• Other study ID #: 14-000639
• Status: Completed
• Phase: Phase 1
• First received: March 18, 2014
• Last updated: December 22, 2015
• Start date: March 2014
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Drug:
• Omega-3 fatty acids

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and following 4 months intervention	No
Primary	Change in Muscle mitochondrial function	Mitochondrial function will be measured in isolated mitochondria by high-resolution respirometry.	Baseline and following 4 months intervention	No