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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03462771
Other study ID # 5607/2016
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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