Dietary Supplementation With Omega-3 Fatty Acid in Muscle Response

May 3, 2018 updated by: Eduardo Ferriolli

Effect of Dietary Supplementation With Omega-3 Fatty Acid on the Adaptive Muscular Response to Resistance Training in Sarcopenic Elderly Women

Both aging and other factors associated with it may contribute to the development of sarcopenia, such as lack of physical activity, inadequate food intake, hormonal changes and age-related increases in cytokine levels. What is a growing number of elderly people in Brazil and the world, it is extremely important to conduct research in order to know the mechanisms of action of new strategies to combat sarcopenia. Supplementation with omega-3 fatty acids is a promising intervention in sarcopenic rest. However, there is a practice of studies confirming the effects of omega-3 fatty acid supplementation on neuromuscular function in the elderly.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to investigate the effect of omega 3 polyunsaturated fatty acid supplementation on the muscular adaptive response in sarcopenic elderly women submitted to resistance training. A total of 30 sarcopenic elderly women, aged 65 years or older, were divided into two groups of 15 volunteers: (1) Exercise group and placebo (GEP) and (2) Exercise group and fish oil (GEOP). The two groups underwent a resisted exercise program over 12 weeks in three weekly sessions supervised by physicists and physicists at the School of Physical Education and Sports of Ribeirão Preto (EEFERP). All volunteers (both groups) are also instructed to ingest two food supplement capsules at each main meal, and the GEP group will use capsules composed of sunflower oil as a placebo. The GEOP is directed to take two capsules of fish oil at each main meal, totaling 4 capsules per day, that is, four grams of fish oil. To check the quadriceps muscle volume before and after an intervention, as volunteers from both groups are submitted to MRI. An extension power and isokinetic force of extension of the lower limb at a knee and hip extension and are measured by dynamometry (Biodex 4 Pro, Biodex, USA) and a functional solution evaluated by the application of the 6-minute walk test. In addition, will be described the biochemicals for the quantification of the following cytokines: IL1, IL6, IL8, IL10 and TNF-α, such as to allow selection of the presence of inflammation.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • SP
      • Ribeirão Preto, SP, Brazil, 14048-900
        • Recruiting
        • Clinics Hospital of the Ribeirao Preto Medical School Ribeirão Preto
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Being sedentary (moderate to vigorous physical activity for at least 3 months)
  • BMI <30.00 kg / m2;

Exclusion Criteria:

  • Any type of absolute and / or relative contraindication to moderate or intense physical activity.
  • Any physical limitation that makes it impossible to practice physical activities and / or that impairs the performance of the tests.
  • Also not included are those volunteers who do not go through pre-Physical Activity evaluation. (Par Q Questionnaire)
  • miss more than 3 workouts consecutive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group exercise fish oil
Using the Randomizer Research program, 15 elderly women will participate in a resistance exercise protocol and receive omega-3 fatty acid supplements to be ingested 2g in the main meals, totaling 4g daily.
Drug: Fish oil
4g of fish oil daily for 14 weeks
Other Names:
  • Omega 3
Placebo Comparator: Group exercise placebo
Using the Randomizer Research program, 15 elderly women will participate in a resistance exercise protocol and receive sunflower oil to be ingested 2g in the main meals, totaling 4g daily.
Drug: sunflower oil
4g of sunflower oil daily for 14 weeks
Other Names:
  • Omega 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline muscle volume after 14 weeks
Time Frame: before and after 14 weeks
Calculated by Nuclear Magnetic Resonance
before and after 14 weeks
Change from Baseline muscle strength of knee extensors after 14 weeks
Time Frame: before and after 14 weeks
Measure of muscle strength of the lower limbs (knee extension) with a isokinetic dynamometer (Biodex 4 Pro)
before and after 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of serum levels of inflammatory cytokines
Time Frame: before and after 14 weeks
Evaluated by blood samples
before and after 14 weeks
Assessment of physical performance
Time Frame: before and after 14 weeks
The physical performance will be evaluated by the Short Physical Performance Battery test.
before and after 14 weeks
Assessment of handgrip strength
Time Frame: before and after 14 weeks
Measure of handgrip strength with a manual dynamometer (Saehan)
before and after 14 weeks
Physical Activity behaviour
Time Frame: before and after 14 weeks
use of a tri-axial accelerometer to measure profile of spontaneous physical activity
before and after 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eduardo Ferriolli

Investigators

  • Principal Investigator: Eduardo Ferriolli, PhD, University of Sao Paulo
  • Study Chair: Carolyn Greig, University of Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 21, 2018

Primary Completion (Anticipated)

July 30, 2018

Study Completion (Anticipated)

November 30, 2018

Study Registration Dates

First Submitted

February 26, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5607/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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