Dietary Supplementation With Omega-3 Fatty Acid in Muscle Response

NCT ID: NCT03462771

Last Updated: 2018-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-21

Study Completion Date

2018-11-30

Brief Summary

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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

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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.

Conditions

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Elderly Women Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Fish oil

Intervention Type DRUG

4g of fish oil daily for 14 weeks

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.

Group Type PLACEBO_COMPARATOR

sunflower oil

Intervention Type DRUG

4g of sunflower oil daily for 14 weeks

Interventions

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Fish oil

4g of fish oil daily for 14 weeks

Intervention Type DRUG

sunflower oil

4g of sunflower oil daily for 14 weeks

Intervention Type DRUG

Other Intervention Names

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Omega 3 Omega 6

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eduardo Ferriolli

OTHER

Sponsor Role lead

Responsible Party

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Eduardo Ferriolli

Assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Eduardo Ferriolli, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Carolyn Greig

Role: STUDY_CHAIR

University of Birmingham

Locations

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Clinics Hospital of the Ribeirao Preto Medical School Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Natália Maira da C Alves, Master

Role: CONTACT

+5516991993493

Karina Pfrimer, PhD

Role: CONTACT

+551633153370

Facility Contacts

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Natália Maira da C Alves, Master

Role: primary

16991993493

References

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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.

Reference Type BACKGROUND
PMID: 20392703 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27852617 (View on PubMed)

Other Identifiers

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5607/2016

Identifier Type: -

Identifier Source: org_study_id

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