Back to results

Omega-3 Fatty Acids to Combat Sarcopenia

Primary Purpose

Sarcopenia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Omega-3 fatty acids

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omega-3 fatty acids

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Change in Muscle mitochondrial function

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02103842

First Posted

March 18, 2014

Last Updated

December 22, 2015

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT02103842

Brief Title

Omega-3 Fatty Acids to Combat Sarcopenia

Official Title

Omega-3 Fatty Acids to Combat Sarcopenia

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcopenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Omega-3 fatty acids

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Omega-3 fatty acids

Primary Outcome Measure Information:

Title

Change in Muscle protein synthesis

Description

Skeletal muscle protein synthesis will be measured from the rate of incorporation of infused amino acids measured by mass spectrometry.

Time Frame

Baseline and following 4 months intervention

Title

Change in Muscle mitochondrial function

Description

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

Time Frame

Baseline and following 4 months intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ian R Lanza, PhD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Omega-3 Fatty Acids to Combat Sarcopenia

We'll reach out to this number within 24 hrs