Omega-3 Fatty Acid Supplementation in Older Adults

Inflammation Clinical Trial

Official title:

The Impact of Omega-3 Fatty Acid Supplementation on Markers of Inflammation and Lean Body Mass in Older Adults

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01666392
• Other study ID #: #2232
• Secondary ID: #2232
• Status: Withdrawn
• Phase: N/A
• First received: August 10, 2012
• Last updated: October 8, 2012
• Start date: August 2012
• Est. completion date: April 2013

Study information

• Verified date: August 2012
• Source: University of Memphis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 60 years of age or over

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammation

Intervention

Dietary Supplement:
• Omega-3 fatty acid
Omega-3 fatty acid, Eicosapentaenoic acid+docosahexaenoic acid in capsule form
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Department of Health and Sport Sciences, The University of Memphis	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Memphis	Nordic Naturals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EPA and DHA	To determine the effectiveness of fish oil supplementation, we measure EPA and DHA Omega-3 fatty acid levels	At baseline and at 3 month endpoint	No
Primary	C-Reactive protein	Inflammatory marker	At baseline testing and at 3 month endpoint	No
Primary	IL6	Inflammatory cytokine	At baseline and at 3 month endpoint	No
Primary	TNFa	Inflammatory cytokine	At baseline and at 3 month endpoint	No
Secondary	Skeletal muscle mass/body composition	The amount of skeletal muscle mass and fat mass and their ration will be determined.	At baseline testing and at 3 month endpoint	No
Secondary	Lower body muscular strength	Measurement of maximum strength in the leg press exercise	At baseline and at 3 month endpoint	No
Secondary	Upper body muscular strength	Measurement of maximum strength in the chest press exercise	At baseline and at 3 month endpoint	No