NCT00794079

Brief Summary

The purpose of this study is to determine whether omega-3 fatty acid supplementation influences muscle protein synthesis rates in young and older adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 3, 2011

Status Verified

August 1, 2011

Enrollment Period

3.5 years

First QC Date

November 18, 2008

Last Update Submit

August 2, 2011

Conditions

Healthy

Keywords

Healthy volunteersyoung adultsAged

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effect of omega-3 fatty acid supplementation on skeletal muscle protein synthesis rates both in the basal, postabsorptive state and in response to infusion of insulin and amino acids in young and older adults

    Measurements taken prior to and following 8 weeks of supplementation

Secondary Outcomes (3)

  • Evaluate the effect of omega-3 fatty acid supplementation on anabolic signaling pathways in skeletal muscle

    Measurements taken prior to and following 8 weeks of supplementation

  • Evaluate the effect of omega-3 fatty acid supplementation on inflammatory cytokines in the systemic circulation and inflammatory signaling pathways in skeletal muscle

    Measurements taken prior to and following 8 weeks of supplementation

  • Compare muscle protein synthesis rates between men and women in the basal, postabsorptive state and in response to insulin and amino acid infusion

    prior to supplementation only

Study Arms (2)

A

EXPERIMENTAL

omega-3 fatty acids

Dietary Supplement: omega-3 fatty acids

B

PLACEBO COMPARATOR

corn oil

Dietary Supplement: corn oil

Interventions

omega-3 fatty acidsDIETARY_SUPPLEMENT

4 grams per day for 8 weeks

Also known as: Lovaza
A
corn oilDIETARY_SUPPLEMENT

4 grams per day for 8 weeks

B

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) \< 30 kg/m2;
  • Age 18-45 yr; or
  • Age 65-85 yr

You may not qualify if:

  • Those taking medications known to affect substrate metabolism or medications that may confound the findings from our study (synthetic steroids, glucocorticoids etc.);
  • Those with evidence of significant organ system dysfunction (e.g. diabetes mellitis, cirrhosis, hypo- or hyperthyroidism; hypertension);
  • Body mass index \> 30 kg/m2
  • Age \<18 yr, 45-65 yr or \> 85 yr
  • Those performing \>1.5h of exercise/wk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in Saint Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

  • Smith GI, Atherton P, Reeds DN, Mohammed BS, Rankin D, Rennie MJ, Mittendorfer B. Dietary omega-3 fatty acid supplementation increases the rate of muscle protein synthesis in older adults: a randomized controlled trial. Am J Clin Nutr. 2011 Feb;93(2):402-12. doi: 10.3945/ajcn.110.005611. Epub 2010 Dec 15.

    PMID: 21159787RESULT

  • Smith GI, Atherton P, Reeds DN, Mohammed BS, Rankin D, Rennie MJ, Mittendorfer B. Omega-3 polyunsaturated fatty acids augment the muscle protein anabolic response to hyperinsulinaemia-hyperaminoacidaemia in healthy young and middle-aged men and women. Clin Sci (Lond). 2011 Sep;121(6):267-78. doi: 10.1042/CS20100597.

    PMID: 21501117RESULT

  • Smith GI, Atherton P, Reeds DN, Mohammed BS, Jaffery H, Rankin D, Rennie MJ, Mittendorfer B. No major sex differences in muscle protein synthesis rates in the postabsorptive state and during hyperinsulinemia-hyperaminoacidemia in middle-aged adults. J Appl Physiol (1985). 2009 Oct;107(4):1308-15. doi: 10.1152/japplphysiol.00348.2009. Epub 2009 Jul 30.

    PMID: 19644030RESULT

MeSH Terms

Interventions

Fatty Acids, Omega-3OmacorCorn Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsFats, UnsaturatedPlant OilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Bettina Mittendorfer, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2008

First Posted

November 19, 2008

Study Start

June 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 3, 2011

Record last verified: 2011-08

Locations

US(1)