Dietary Supplementation With Omega-3 Fatty Acid in Muscle Response

NCT03462771 | Unknown DMC

• 1 other identifier: 5607/2016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly Women; Sarcopenia

Keywords

elderly; sarcopenia; dietary supplementation; omega-3 fatty acid

Outcome Measures

Primary Outcomes (2)

• Change from Baseline muscle volume after 14 weeks

  Calculated by Nuclear Magnetic Resonance

  before and after 14 weeks

• 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)

  before and after 14 weeks

Secondary Outcomes (4)

• Assessment of serum levels of inflammatory cytokines

  before and after 14 weeks

• Assessment of physical performance

  before and after 14 weeks

• Assessment of handgrip strength

  before and after 14 weeks

• Physical Activity behaviour

  before and after 14 weeks

Study Arms (2)

Group exercise fish oil

EXPERIMENTAL

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

Group exercise placebo

PLACEBO COMPARATOR

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

Interventions

Fish oil DRUG

4g of fish oil daily for 14 weeks

Also known as: Omega 3

Group exercise fish oil

sunflower oil DRUG

4g of sunflower oil daily for 14 weeks

Also known as: Omega 6

Group exercise placebo

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eduardo Ferriolli: lead

Study Sites (1)

Clinics Hospital of the Ribeirao Preto Medical School Ribeirão Preto

Ribeirão Preto, São Paulo, 14048-900, Brazil

RECRUITING

Related Publications (2)

• 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.

  PMID: 20392703 BACKGROUND

• 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.

  PMID: 27852617 BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Interventions

Fish Oils; Docosahexaenoic Acids; Sunflower Oil

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Eduardo Ferriolli, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Carolyn Greig

  University of Birmingham

  STUDY CHAIR

Central Study Contacts

Natália Maira da C Alves, Master

CONTACT

+5516991993493; nat_aux2006@hotmail.com

Karina Pfrimer, PhD

CONTACT

+551633153370; kpfrimer@fmrp.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 13, 2018
• Study Start: May 21, 2018
• Primary Completion: July 30, 2018
• Study Completion: November 30, 2018
• Last Updated: May 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)