Omega-3 Fatty Acids to Combat Sarcopenia

NCT02103842 | Completed Phase 1 DMC

• 1 other identifier: 14-000639
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (2)

• 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

• Change in Muscle mitochondrial function

  Mitochondrial function will be measured in isolated mitochondria by high-resolution respirometry.

  Baseline and following 4 months intervention

Study Arms (1)

Omega-3 fatty acids

EXPERIMENTAL

Participants will take 3.9g/day of Eicosapentaenoic acid and docosahexaenoic acid for 4 months

Drug: Omega-3 fatty acids

Interventions

Omega-3 fatty acids DRUG

Omega-3 fatty acids

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-35 or 65-85 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Ian R Lanza, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: April 4, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

US (1)