Elderly WomenNCT03462771
Dietary Supplementation With Omega-3 Fatty Acid in Muscle Response
A study testing Fish oil and sunflower oil in people with Elderly Women and Sarcopenia, run by Eduardo Ferriolli at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Elderly Women, Sarcopenia
- What is being tested?
- Fish oil and sunflower oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 21 May 2018to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Being sedentary (moderate to vigorous physical activity for at least 3 months)
- BMI <30.00 kg / m2;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Clinics Hospital of the Ribeirao Preto Medical School Ribeirão Preto
Ribeirão Preto, São Paulo, 14048-900
Natália Maira da C Alves, Master, 16991993493, nat_aux2006@hotmail.com
About this study
Official title: Effect of Dietary Supplementation With Omega-3 Fatty Acid on the Adaptive Muscular Response to Resistance Training in Sarcopenic Elderly Women
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.
Read the 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.
- Conditions
- Elderly Women, Sarcopenia
- Being tested
- Fish oil, sunflower oil
- Keywords
- elderly, sarcopenia, dietary supplementation, omega-3 fatty acid
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oilDrug
Also called Omega 3
4g of fish oil daily for 14 weeks
sunflower oilDrug
Also called Omega 6
4g of sunflower oil daily for 14 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: sunflower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline muscle volume after 14 weeks
Calculated by Nuclear Magnetic Resonance
Measured: 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)
Measured: before and after 14 weeks
Secondary outcomes (4)
Assessment of serum levels of inflammatory cytokines
Evaluated by blood samples
Measured: before and after 14 weeks
Assessment of physical performance
The physical performance will be evaluated by the Short Physical Performance Battery test.
Measured: before and after 14 weeks
Assessment of handgrip strength
Measure of handgrip strength with a manual dynamometer (Saehan)
Measured: before and after 14 weeks
Physical Activity behaviour
use of a tri-axial accelerometer to measure profile of spontaneous physical activity
Measured: before and after 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start21 May 2018 (estimated)
- Primary completion30 Jul 2018 (estimated)
- Study completion30 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Elderly WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eduardo Ferriolli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eduardo Ferriolli, University of Sao Paulo
- Investigators
- Eduardo Ferriolli, PhD, Principal investigator, University of Sao PauloCarolyn Greig, Study chair, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462771
- Sponsor's protocol ID
- 5607/2016
- Status last verified
- May 2018
- First submitted
- 26 Feb 2018
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20392703Da 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.
PubMed 27852617
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Supplementation With Omega-3 Fatty Acid on the Adaptive Muscular Response to Resistance Training in Sarcopenic Elderly Women
- ClinicalTrials.gov ID
- NCT03462771
- Acronym / sponsor ID
- 5607/2016
- Conditions
- Elderly Women, Sarcopenia
- Keywords
- elderly, sarcopenia, dietary supplementation, omega-3 fatty acid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Eduardo FerriolliUniversity, hospital or other
- Study start
- 21 May 2018 (estimated)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group exercise fish oil | Experimental | Drug: Fish oilUsing 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 exercise placebo | Placebo comparator | Drug: sunflower oilUsing 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Being sedentary (moderate to vigorous physical activity for at least 3 months)
- BMI <30.00 kg / m2;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oilAlso: Omega 34g of fish oil daily for 14 weeks | Drug | Group exercise fish oil |
| sunflower oilAlso: Omega 64g of sunflower oil daily for 14 weeks | Drug | Group exercise placebo |
Primary outcome
Change from Baseline muscle volume after 14 weeks
Time frame: before and after 14 weeks
Calculated by Nuclear Magnetic Resonance
Change from Baseline muscle strength of knee extensors after 14 weeks
Time frame: before and after 14 weeks
Measure of muscle strength of the lower limbs (knee extension) with a isokinetic dynamometer (Biodex 4 Pro)
4 secondary outcomes
Assessment of serum levels of inflammatory cytokines
Time frame: before and after 14 weeks
Assessment of physical performance
Time frame: before and after 14 weeks
Assessment of handgrip strength
Time frame: before and after 14 weeks
Physical Activity behaviour
Time frame: before and after 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Background: PubMed 20392703Cruz-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.
- Background: PubMed 27852617Da 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Ferriolli, PhD principal investigator
University of Sao Paulo
Carolyn Greig study chair
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil and sunflower oil in people with Elderly Women and Sarcopenia, run by Eduardo Ferriolli at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natália Maira da C Alves, Master (+5516991993493, nat_aux2006@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline muscle volume after 14 weeks (time frame: before and after 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03462771, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.