Dietary Supplementation With Omega-3 Fatty Acid in Muscle Response

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03462771
• Other study ID #: 5607/2016
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: May 2018
• Source: University of Sao Paulo
• Contact: Natália Maira da C Alves, Master
• Phone: +5516991993493
• Email: nat_aux2006[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Elderly Women
• Sarcopenia

Intervention

Drug:
• Fish oil
4g of fish oil daily for 14 weeks
• sunflower oil
4g of sunflower oil daily for 14 weeks

Locations

Country	Name	City	State
Brazil	Clinics Hospital of the Ribeirao Preto Medical School Ribeirão Preto	Ribeirão Preto	SP

Sponsors (1)

Lead Sponsor	Collaborator
Eduardo Ferriolli

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinková 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline muscle volume after 14 weeks	Calculated by Nuclear Magnetic Resonance	before and after 14 weeks
Primary	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	Assessment of serum levels of inflammatory cytokines	Evaluated by blood samples	before and after 14 weeks
Secondary	Assessment of physical performance	The physical performance will be evaluated by the Short Physical Performance Battery test.	before and after 14 weeks
Secondary	Assessment of handgrip strength	Measure of handgrip strength with a manual dynamometer (Saehan)	before and after 14 weeks
Secondary	Physical Activity behaviour	use of a tri-axial accelerometer to measure profile of spontaneous physical activity	before and after 14 weeks