NCT01666392

Brief Summary

The purpose of this study to determine whether Fish oil (Omega-3 Fatty Acid) supplementation has an impact on inflammation and lean body mass in older adults. The investigators expect that Fish oil supplementation will reduce inflammation and prevent the loss of lean mass compared to placebo.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

October 10, 2012

Status Verified

August 1, 2012

Enrollment Period

8 months

First QC Date

August 10, 2012

Last Update Submit

October 8, 2012

Conditions

Inflammation

Keywords

Omega-3 fatty acidFish oilMuscle massMuscle strengthOlder adultsCirculating inflammatory cytokinesSkeletal muscle massUpper body strengthLower body strength

Outcome Measures

Primary Outcomes (3)

  • C-Reactive protein

    Inflammatory marker

    At baseline testing and at 3 month endpoint

  • IL6

    Inflammatory cytokine

    At baseline and at 3 month endpoint

  • TNFα

    Inflammatory cytokine

    At baseline and at 3 month endpoint

Secondary Outcomes (3)

  • Skeletal muscle mass/body composition

    At baseline testing and at 3 month endpoint

  • Lower body muscular strength

    At baseline and at 3 month endpoint

  • Upper body muscular strength

    At baseline and at 3 month endpoint

Other Outcomes (1)

  • EPA and DHA

    At baseline and at 3 month endpoint

Study Arms (2)

Fish oil (Omega-3 fatty acid)

EXPERIMENTAL

2 capsules/day of ProOmega providing 650mg EPA and 450mg DHA

Dietary Supplement: Omega-3 fatty acid

Soybean oil

PLACEBO COMPARATOR

2 capsules/day

Dietary Supplement: Placebo

Interventions

Omega-3 fatty acidDIETARY_SUPPLEMENT

Omega-3 fatty acid, Eicosapentaenoic acid+docosahexaenoic acid in capsule form

Also known as: ProOmega (Nordic Naturals)
Fish oil (Omega-3 fatty acid)
PlaceboDIETARY_SUPPLEMENT

Placebo

Soybean oil

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or over

You may not qualify if:

  • Fish, seafood allergies, nut allergies, soy allergies
  • Habitual (\>1/week) fish or seafood consumption
  • Current Omega-3 supplement use
  • Gastrointestinal problems
  • Current anti-inflammatory medication use
  • Current anticoagulant medication use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Health and Sport Sciences, The University of Memphis

Memphis, Tennessee, 38152, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Zsolt Murlasits, Ph.D.

    The University of Memphis

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 10, 2012

First Posted

August 16, 2012

Study Start

August 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

October 10, 2012

Record last verified: 2012-08

Locations

US(1)