AgeingNCT02843009
Fish Oil and Adaptations to Resistance Exercise in Older People
A study testing Resistance Exercise Training and Supplementation in people with Ageing, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
Skeletal muscle is the largest organ in the human body and has many important roles in determining our physical abilities and overall wellbeing. One major function of skeletal muscle is to carry out many daily tasks, such as rising from a chair or getting on a bus, tasks often referred to as functional abilities. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ageing
- What is being tested?
- Resistance Exercise Training and Supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Sep 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Over 65 years of age
- Not consuming oily fish regularly
- Not consuming nutritional supplements
- Not participating in resistance exercise training
Who cannot join
- History of myocardial infarction within previous 2 years
- Cardiac illness: moderate/ severe aortic stenosis, acute pericarditis, acute myocarditis, aneurysm, severe angina, clinically significant valvular disease, uncontrolled dysrhythmia, claudication within the previous 10 years
- Thrombophlebitis or pulmonary embolus within the previous 2 years
- History of cerebrovascular disease (CVA or TIA) within the previous 2 years
- Acute febrile illness within the previous 3 months
- Severe airflow obstruction
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- Uncontrolled metabolic disease (e.g., thyroid disease or cancer)
- Significant emotional distress, psychotic illness or depression within the previous 2 years
- Lower limb fracture sustained within the previous 2 years; upper limb fracture within the previous 6 months; non arthroscopic lower limb joint surgery within the previous 2 years
- Any reason for loss of mobility for greater than 1 week in the previous 2 months or greater than 2 weeks in the previous 6 months
- Poorly controlled atrial fibrillation
- Poor (chronic) pain control
- Resting systolic pressure >200 mmHg or resting diastolic pressure >100 mmHg
- Moderate/ severe cognitive impairment (MMSE <23)
- Impaired tissue viability (defined by a Waterlow risk assessment score >15).
- Based on Greig C.A. et al. Age Ageing 1994, 23: 185-9
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Overcoming the Blunted Response to Resistance Exercise With Fish Oil to Maximise Musculoskeletal Properties and Functional Abilities in Older People
Skeletal muscle is the largest organ in the human body and has many important roles in determining our physical abilities and overall wellbeing. One major function of skeletal muscle is to carry out many daily tasks, such as rising from a chair or getting on a bus, tasks often referred to as functional abilities. During healthy ageing muscle size is reduced by approximately 0.5-2% a year (known as sarcopenia), with concurrent reductions in functional abilities. This can result in a reduction in quality of life and loss of independence, both of which are clearly not desirable. The incidence of sarcopenia is around 20% between 50-70 years and around 50% in those over 80 years, with the absolute numbers and the average age of the population rising. One method through which muscle function can be enhanced and retard the progression of sarcopenia, across all age groups, is through exercise. The effectiveness of exercise will depend on a number of genetic and environmental factors, with nutritional intake being one of the most important and easily altered. Recent research has suggested that altering the type of fatty acids consumed may have a positive effect on muscle function. Little research is yet to be carried out in elderly humans. This is important as that findings from animal models are not definitively transferrable to humans. The main aim of the current proposal, therefore, is to investigate the effect the consumption of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), long chain polyunsaturated fatty acids found in oily fish, on the response to a resistance training programme in the elderly. A further aim is to determine the mechanisms which result in these adaptive responses. The project will be centred round a large 18 week resistance training/nutritional (EPA/DHA) intervention with both males and females over the age of 65 years. There are three main research questions and experiments stemming from this intervention. 1) Does the consumption of EPA and DHA result in a greater increase in strength, power and functional abilities in response to resistance training? To answer this question a series of measures of muscular performance and functional abilities will be assessed. 2) Does the consumption of EPA and DHA increase the size and quality of muscles, reduce the amount of fat found within the muscle and decrease inflammation? To address this question the participants will have MRI images of their muscles and blood samples taken before and after the intervention. This will allow the calculation of muscle mass/fat content and circulating levels of inflammatory markers. 3) Does the consumption of EPA and DHA enhance the activity of the molecules involved in controlling muscle mass after a single bout of resistance exercise? For this question muscle samples will be obtained before and after a single training session and measure changes in molecules previously identified as important in the changes in muscle mass in response to exercise. A fourth aim running throughout the proposal is 4) Do males and females respond differently to the combination of EPA/DHA and resistance exercise? Differences in protein metabolism have previously been noted between genders and yet the investigation of these differences is often overlooked. The investigators will investigate this by studying responses in groups of males and females. In summary, the aim of the proposed project is to test the hypothesis that the consumption of fatty acids found in oily fish will improve the response of an elderly population to a resistance training intervention. The major outcome of the proposal would be in establishing a beneficial effect of fish oil on muscular adaptation in the elderly, opening up a widely available therapeutic strategy for an improvement in the quality of life in the elderly population. Such strategies are of particular importance due to the increasing age of the UK population.
- Conditions
- Ageing
- Being tested
- Resistance Exercise Training, Supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Exercise TrainingBehavioural
Resistance exercise will involve 2 sessions per week for 18 weeks. Each session will involve participants carrying out the following exercises: calf press, leg press, leg extension and leg curl
SupplementationDietary supplement
Participants randomised to either 3g/day of fish oil or safflower oil for 18 weeks
| Study group | Role | What they receive |
|---|---|---|
| Safflower Oil plus Resistance Exercise Training | Placebo comparator | 3.0g of safflower oil taken daily alongside twice weekly resistance exercise training sessions for 18 weeks Receives: Behavioral: Resistance Exercise Training; Dietary Supplement: Supplementation |
| Fish Oil plus Resistance Exercise Training | Active comparator | 3.0g of fish oil taken daily alongside twice weekly resistance exercise training sessions for 18 weeks Receives: Behavioral: Resistance Exercise Training; Dietary Supplement: Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Isometric Knee Extensor Torque
Measured: Change from baseline at 18 weeks
Secondary outcomes (8)
Short Performance Physical Battery Test
Measured: Change from baseline at 18 weeks
Maximal Isokinetic Knee Extensor Torque (30,90 and 120 degrees/s)
Measured: Change from baseline at 18 weeks
Quadriceps Cross Sectional Area (MRI)
Measured: Change from baseline at 18 weeks
Circulating markers of inflammation (IL-6 and TNF-alpha)
Measured: Change from baseline at 18 weeks
Muscle protein synthesis
Measured: 18 weeks
Muscle P70s6k activity
Measured: Change from baseline to 2h post-exercise
Erythrocyte fatty acid composition
Measured: Change from baseline at 18 weeks
Muscle membrane fatty acid composition
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startSep 2012
- Primary completionSep 2015
- Study completionSep 2015
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 AgeingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Gray, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843009
- Sponsor's protocol ID
- Gray BBSRC NI
- Status last verified
- Jul 2016
- First submitted
- 18 Jul 2016
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Da Boit M, Tommasi S, Elliot D, Zinellu A, Sotgia S, Sibson R, Meakin JR, Aspden RM, Carru C, Mangoni AA, Gray SR. Sex Differences in the Associations between L-Arginine Pathway Metabolites, Skeletal Muscle Mass and Function, and their Responses to Resistance Exercise, in Old Age. J Nutr Health Aging. 2018;22(4):534-540. doi: 10.1007/s12603-017-0964-6.
PubMed 29582894Da 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 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming the Blunted Response to Resistance Exercise With Fish Oil to Maximise Musculoskeletal Properties and Functional Abilities in Older People
- ClinicalTrials.gov ID
- NCT02843009
- Acronym / sponsor ID
- Gray BBSRC NI
- Conditions
- Ageing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Jul 2016 (estimated)
- 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.
Skeletal muscle is the largest organ in the human body and has many important roles in determining our physical abilities and overall wellbeing. One major function of skeletal muscle is to carry out many daily tasks, such as rising from a chair or getting on a bus, tasks often referred to as functional abilities. During healthy ageing muscle size is reduced by approximately 0.5-2% a year (known as sarcopenia), with concurrent reductions in functional abilities. This can result in a reduction in quality of life and loss of independence, both of which are clearly not desirable. The incidence of sarcopenia is around 20% between 50-70 years and around 50% in those over 80 years, with the absolute numbers and the average age of the population rising. One method through which muscle function can be enhanced and retard the progression of sarcopenia, across all age groups, is through exercise. The effectiveness of exercise will depend on a number of genetic and environmental factors, with nutritional intake being one of the most important and easily altered. Recent research has suggested that altering the type of fatty acids consumed may have a positive effect on muscle function. Little research is yet to be carried out in elderly humans. This is important as that findings from animal models are not definitively transferrable to humans. The main aim of the current proposal, therefore, is to investigate the effect the consumption of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), long chain polyunsaturated fatty acids found in oily fish, on the response to a resistance training programme in the elderly. A further aim is to determine the mechanisms which result in these adaptive responses. The project will be centred round a large 18 week resistance training/nutritional (EPA/DHA) intervention with both males and females over the age of 65 years. There are three main research questions and experiments stemming from this intervention. 1) Does the consumption of EPA and DHA result in a greater increase in strength, power and functional abilities in response to resistance training? To answer this question a series of measures of muscular performance and functional abilities will be assessed. 2) Does the consumption of EPA and DHA increase the size and quality of muscles, reduce the amount of fat found within the muscle and decrease inflammation? To address this question the participants will have MRI images of their muscles and blood samples taken before and after the intervention. This will allow the calculation of muscle mass/fat content and circulating levels of inflammatory markers. 3) Does the consumption of EPA and DHA enhance the activity of the molecules involved in controlling muscle mass after a single bout of resistance exercise? For this question muscle samples will be obtained before and after a single training session and measure changes in molecules previously identified as important in the changes in muscle mass in response to exercise. A fourth aim running throughout the proposal is 4) Do males and females respond differently to the combination of EPA/DHA and resistance exercise? Differences in protein metabolism have previously been noted between genders and yet the investigation of these differences is often overlooked. The investigators will investigate this by studying responses in groups of males and females. In summary, the aim of the proposed project is to test the hypothesis that the consumption of fatty acids found in oily fish will improve the response of an elderly population to a resistance training intervention. The major outcome of the proposal would be in establishing a beneficial effect of fish oil on muscular adaptation in the elderly, opening up a widely available therapeutic strategy for an improvement in the quality of life in the elderly population. Such strategies are of particular importance due to the increasing age of the UK population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safflower Oil plus Resistance Exercise Training | Placebo comparator | Behavioral: Resistance Exercise Training, Dietary Supplement: Supplementation3.0g of safflower oil taken daily alongside twice weekly resistance exercise training sessions for 18 weeks |
| Fish Oil plus Resistance Exercise Training | Active comparator | Behavioral: Resistance Exercise Training, Dietary Supplement: Supplementation3.0g of fish oil taken daily alongside twice weekly resistance exercise training sessions for 18 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Over 65 years of age
- Not consuming oily fish regularly
- Not consuming nutritional supplements
- Not participating in resistance exercise training
Key exclusion criteria (16 listed)
- History of myocardial infarction within previous 2 years
- Cardiac illness: moderate/ severe aortic stenosis, acute pericarditis, acute myocarditis, aneurysm, severe angina, clinically significant valvular disease, uncontrolled dysrhythmia, claudication within the previous 10 years
- Thrombophlebitis or pulmonary embolus within the previous 2 years
- History of cerebrovascular disease (CVA or TIA) within the previous 2 years
- Acute febrile illness within the previous 3 months
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 |
|---|---|---|
| Resistance Exercise TrainingResistance exercise will involve 2 sessions per week for 18 weeks. Each session will involve participants carrying out the following exercises: calf press, leg press, leg extension and leg curl | Behavioural | Fish Oil plus Resistance Exercise Training, Safflower Oil plus Resistance Exercise Training |
| SupplementationParticipants randomised to either 3g/day of fish oil or safflower oil for 18 weeks | Dietary supplement | Fish Oil plus Resistance Exercise Training, Safflower Oil plus Resistance Exercise Training |
Primary outcome
Maximal Isometric Knee Extensor Torque
Time frame: Change from baseline at 18 weeks
8 secondary outcomes
Short Performance Physical Battery Test
Time frame: Change from baseline at 18 weeks
Maximal Isokinetic Knee Extensor Torque (30,90 and 120 degrees/s)
Time frame: Change from baseline at 18 weeks
Quadriceps Cross Sectional Area (MRI)
Time frame: Change from baseline at 18 weeks
Circulating markers of inflammation (IL-6 and TNF-alpha)
Time frame: Change from baseline at 18 weeks
Muscle protein synthesis
Time frame: 18 weeks
Muscle P70s6k activity
Time frame: Change from baseline to 2h post-exercise
Erythrocyte fatty acid composition
Time frame: Change from baseline at 18 weeks
Muscle membrane fatty acid composition
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Derived from this study: PubMed 29582894Da Boit M, Tommasi S, Elliot D, Zinellu A, Sotgia S, Sibson R, Meakin JR, Aspden RM, Carru C, Mangoni AA, Gray SR. Sex Differences in the Associations between L-Arginine Pathway Metabolites, Skeletal Muscle Mass and Function, and their Responses to Resistance Exercise, in Old Age. J Nutr Health Aging. 2018;22(4):534-540. doi: 10.1007/s12603-017-0964-6.
- Derived from this study: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise Training and Supplementation in people with Ageing, run by University of Glasgow at 1 site in United Kingdom.
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 4 inclusion and 16 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: finished, as of the sponsor's last update on 25 Jul 2016. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Isometric Knee Extensor Torque (time frame: Change from baseline at 18 weeks). 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 NCT02843009, 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 25 Jul 2016.