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Dietary Supplementation With Omega-3 Fatty Acid in Muscle Response

Primary Purpose

Elderly Women, Sarcopenia

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Fish oil
sunflower oil
Sponsored by
Eduardo Ferriolli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Elderly Women focused on measuring elderly, sarcopenia, dietary supplementation, omega-3 fatty acid

Eligibility Criteria

65 Years - 85 Years (Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Clinics Hospital of the Ribeirao Preto Medical School Ribeirão PretoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group exercise fish oil

Group exercise placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 26, 2018
Last Updated
May 3, 2018
Sponsor
Eduardo Ferriolli
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1. Study Identification

Unique Protocol Identification Number
NCT03462771
Brief Title
Dietary Supplementation With Omega-3 Fatty Acid in Muscle Response
Official Title
Effect of Dietary Supplementation With Omega-3 Fatty Acid on the Adaptive Muscular Response to Resistance Training in Sarcopenic Elderly Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 21, 2018 (Anticipated)
Primary Completion Date
July 30, 2018 (Anticipated)
Study Completion Date
November 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eduardo Ferriolli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly Women, Sarcopenia
Keywords
elderly, sarcopenia, dietary supplementation, omega-3 fatty acid

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group exercise fish oil
Arm Type
Experimental
Arm Description
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.
Arm Title
Group exercise placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fish oil
Other Intervention Name(s)
Omega 3
Intervention Description
4g of fish oil daily for 14 weeks
Intervention Type
Drug
Intervention Name(s)
sunflower oil
Other Intervention Name(s)
Omega 6
Intervention Description
4g of sunflower oil daily for 14 weeks
Primary Outcome Measure Information:
Title
Change from Baseline muscle volume after 14 weeks
Description
Calculated by Nuclear Magnetic Resonance
Time Frame
before and after 14 weeks
Title
Change from Baseline muscle strength of knee extensors after 14 weeks
Description
Measure of muscle strength of the lower limbs (knee extension) with a isokinetic dynamometer (Biodex 4 Pro)
Time Frame
before and after 14 weeks
Secondary Outcome Measure Information:
Title
Assessment of serum levels of inflammatory cytokines
Description
Evaluated by blood samples
Time Frame
before and after 14 weeks
Title
Assessment of physical performance
Description
The physical performance will be evaluated by the Short Physical Performance Battery test.
Time Frame
before and after 14 weeks
Title
Assessment of handgrip strength
Description
Measure of handgrip strength with a manual dynamometer (Saehan)
Time Frame
before and after 14 weeks
Title
Physical Activity behaviour
Description
use of a tri-axial accelerometer to measure profile of spontaneous physical activity
Time Frame
before and after 14 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natália Maira da C Alves, Master
Phone
+5516991993493
Email
nat_aux2006@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Karina Pfrimer, PhD
Phone
+551633153370
Email
kpfrimer@fmrp.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Ferriolli, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carolyn Greig
Organizational Affiliation
University of Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
Clinics Hospital of the Ribeirao Preto Medical School Ribeirão Preto
City
Ribeirão Preto
State/Province
SP
ZIP/Postal Code
14048-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natália Maira da C Alves, Master
Phone
16991993493
Email
nat_aux2006@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20392703
Citation
Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
Results Reference
background
PubMed Identifier
27852617
Citation
Da Boit M, Sibson R, Sivasubramaniam S, Meakin JR, Greig CA, Aspden RM, Thies F, Jeromson S, Hamilton DL, Speakman JR, Hambly C, Mangoni AA, Preston T, Gray SR. Sex differences in the effect of fish-oil supplementation on the adaptive response to resistance exercise training in older people: a randomized controlled trial. Am J Clin Nutr. 2017 Jan;105(1):151-158. doi: 10.3945/ajcn.116.140780. Epub 2016 Nov 16.
Results Reference
background

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Dietary Supplementation With Omega-3 Fatty Acid in Muscle Response

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