Whole Body and Skeletal Muscle Energy MetabolismNCT02338401
Fish Oil Supplementation, Resting Energy Expenditure, Skeletal Muscle Membrane Composition and Metabolism in Elderly Subjects.
A study testing Omega-3 Complete in people with Whole Body and Skeletal Muscle Energy Metabolism, run by University of Guelph at 1 site in Canada.
Trial summary
Resting metabolic rate (RMR) declines by 1-2% per decade after 20 years of age. This reduction is linked to a decrease in fat free mass (FFM) (10-20%) and the rate of energy expenditure of tissues (Manini 2010). Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Whole Body and Skeletal Muscle Energy Metabolism
- What is being tested?
- Omega-3 Complete
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2015to Sep 2017
- 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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 60 and 75 years old
- Must currently practice a consistent diet and exercise regimen, and maintain this throughout the duration of the study
Who cannot join
- Have any medical condition (no evidence of significant cardiovascular disease or organ dysfunction, including hypertension, dyslipidemia, and diabetes mellitus), and hospitalization or surgeries
- Consume more than two meals of fish/wk and/or have taken an omega-3 supplement during the prior three months.
- Have a BMI > 30 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Fish Oil Supplementation on Resting Energy Expenditure, Skeletal Muscle Membrane Composition and Metabolism in Elderly Subjects.
Resting metabolic rate (RMR) declines by 1-2% per decade after 20 years of age. This reduction is linked to a decrease in fat free mass (FFM) (10-20%) and the rate of energy expenditure of tissues (Manini 2010).
It has also been shown that as we age there is a:
Read more
- Concomitant reduction in basal fat and carbohydrate oxidation, most likely due to the decrease in RMR than to a change in respiratory exchange ratio (RER) (St-Onge and Gallagher 2010).
- A change towards a more saturated membrane of different tissues (Rabini et al 2002).
Incorporation of omega-3s, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), into cell membranes may alter energy metabolism by:
- Increasing the rate at which proteins operate (Hulbert 2007).
- Promoting the release of EPA and DHA into the cytosol which will act as ligands for peroxisome proliferator-activated receptors (PPARs) (Calder 2011). PPARs play an important role in energy homeostasis by regulating genes involved in lipid metabolism (Kota et al 2005).
- Augmenting protein synthesis through activation of the mTOR-p70s6k pathway (Di Girolamo et al 2014).
Supplementation with fish oil in older males and females:
- Increases whole muscle phospholipid profile of EPA and DHA (Smith et al 2011).
- Increases lean body mass (LBM), RMR, and fatty acid oxidation (Logan et al unpublished)
- Decreases carbohydrate oxidation (Logan et al unplubished). Skeletal muscle (SM) accounts for 20-30% of RMR (Zurlo et al 1990, Manini 2010), therefore it is tempting to speculate that these changes may occur by some of the mechanisms described earlier, with skeletal muscle being an important contributor.
To date there are no studies that have examined the effect of n-3 supplementation (3g/day)* on plasma membrane fatty acid composition, RMR and substrate oxidation, and the possible mechanisms behind it.
Therefore the purpose of this study is to determine whether in older adults (female and male), supplementation with n-3 alters:
- RMR and fatty acid oxidation.
- Membrane composition of whole muscle and sarcolemma.
- Content of skeletal muscle membrane fatty acid transport proteins.
- Dose response of NaKATPase and SERCA efficiency
- Content of mitochondrial proteins
- Expression and content of PPARs and proteins involved in translocation of FA transporters (AMPK, ERK1/2, CamKII).
- Phosphorylation of AMPKα(THR172), ERK1/2(THR202 TYR204) and CaMKII(THR286).
- Proteomic profile of skeletal muscle.
- Body composition
- Being tested
- Omega-3 Complete, Placebo Pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 CompleteDietary supplement
Fish Oil Capsules
Placebo PillDietary supplement
Olive Oil Capsules
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 Complete | Experimental | Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks. Receives: Dietary Supplement: Omega-3 Complete |
| Placebo Pill | Placebo comparator | Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks. Receives: Dietary Supplement: Placebo Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skeletal muscle whole muscle membrane fatty acid composition from baseline
Measured: Baseline and 12 weeks
Change in skeletal muscle sodium pump (Na/K ATPase) activity (umol/mg protein/hour)
Measured: Baseline and 12 weeks
Change in skeletal muscle sarcoplasmic reticulum calcium (SERCA) ATPase activity (umol/mg protein/hour)
Measured: Baseline and 12 weeks
Secondary outcomes (6)
Change in whole body resting metabolic rate
Measured: Baseline, 6 and 12 weeks
Change in skeletal muscle membrane fatty acid transporter content
Measured: Baseline and 12 weeks
Change in skeletal muscle content of mitochondrial proteins
Measured: Baseline and 12 weeks
Change in skeletal muscle phosphorylation of AMPKα(THR172), ERK1/2(THR202 TYR204) and CaMKII(THR286)
Measured: Baseline and 12 weeks
Change in skeletal muscle PPARs content
Measured: Baseline and 12 weeks
Change in body composition
Measured: Baseline, 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whole Body and Skeletal Muscle Energy MetabolismStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence Spriet, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338401
- Sponsor's protocol ID
- University of Guelph
- Status last verified
- May 2017
- First submitted
- 10 Jan 2015
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fish Oil Supplementation on Resting Energy Expenditure, Skeletal Muscle Membrane Composition and Metabolism in Elderly Subjects.
- ClinicalTrials.gov ID
- NCT02338401
- Acronym / sponsor ID
- University of Guelph
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 14 Jan 2015 (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.
Resting metabolic rate (RMR) declines by 1-2% per decade after 20 years of age. This reduction is linked to a decrease in fat free mass (FFM) (10-20%) and the rate of energy expenditure of tissues (Manini 2010).
It has also been shown that as we age there is a:
- Concomitant reduction in basal fat and carbohydrate oxidation, most likely due to the decrease in RMR than to a change in respiratory exchange ratio (RER) (St-Onge and Gallagher 2010).
- A change towards a more saturated membrane of different tissues (Rabini et al 2002).
Incorporation of omega-3s, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), into cell membranes may alter energy metabolism by:
- Increasing the rate at which proteins operate (Hulbert 2007).
- Promoting the release of EPA and DHA into the cytosol which will act as ligands for peroxisome proliferator-activated receptors (PPARs) (Calder 2011). PPARs play an important role in energy homeostasis by regulating genes involved in lipid metabolism (Kota et al 2005).
- Augmenting protein synthesis through activation of the mTOR-p70s6k pathway (Di Girolamo et al 2014).
Supplementation with fish oil in older males and females:
- Increases whole muscle phospholipid profile of EPA and DHA (Smith et al 2011).
- Increases lean body mass (LBM), RMR, and fatty acid oxidation (Logan et al unpublished)
- Decreases carbohydrate oxidation (Logan et al unplubished). Skeletal muscle (SM) accounts for 20-30% of RMR (Zurlo et al 1990, Manini 2010), therefore it is tempting to speculate that these changes may occur by some of the mechanisms described earlier, with skeletal muscle being an important contributor.
To date there are no studies that have examined the effect of n-3 supplementation (3g/day)* on plasma membrane fatty acid composition, RMR and substrate oxidation, and the possible mechanisms behind it.
Therefore the purpose of this study is to determine whether in older adults (female and male), supplementation with n-3 alters:
- RMR and fatty acid oxidation.
- Membrane composition of whole muscle and sarcolemma.
- Content of skeletal muscle membrane fatty acid transport proteins.
- Dose response of NaKATPase and SERCA efficiency
- Content of mitochondrial proteins
- Expression and content of PPARs and proteins involved in translocation of FA transporters (AMPK, ERK1/2, CamKII).
- Phosphorylation of AMPKα(THR172), ERK1/2(THR202 TYR204) and CaMKII(THR286).
- Proteomic profile of skeletal muscle.
- Body composition
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Complete | Experimental | Dietary Supplement: Omega-3 CompleteOral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks. |
| Placebo Pill | Placebo comparator | Dietary Supplement: Placebo PillOral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between 60 and 75 years old
- Must currently practice a consistent diet and exercise regimen, and maintain this throughout the duration of the study
Key exclusion criteria (3 listed)
- Have any medical condition (no evidence of significant cardiovascular disease or organ dysfunction, including hypertension, dyslipidemia, and diabetes mellitus), and hospitalization or surgeries
- Consume more than two meals of fish/wk and/or have taken an omega-3 supplement during the prior three months.
- Have a BMI > 30 kg/m2
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 |
|---|---|---|
| Omega-3 CompleteFish Oil Capsules | Dietary supplement | Omega-3 Complete |
| Placebo PillOlive Oil Capsules | Dietary supplement | Placebo Pill |
Primary outcome
Change in skeletal muscle whole muscle membrane fatty acid composition from baseline
Time frame: Baseline and 12 weeks
Change in skeletal muscle sodium pump (Na/K ATPase) activity (umol/mg protein/hour)
Time frame: Baseline and 12 weeks
Change in skeletal muscle sarcoplasmic reticulum calcium (SERCA) ATPase activity (umol/mg protein/hour)
Time frame: Baseline and 12 weeks
6 secondary outcomes
Change in whole body resting metabolic rate
Time frame: Baseline, 6 and 12 weeks
Change in skeletal muscle membrane fatty acid transporter content
Time frame: Baseline and 12 weeks
Change in skeletal muscle content of mitochondrial proteins
Time frame: Baseline and 12 weeks
Change in skeletal muscle phosphorylation of AMPKα(THR172), ERK1/2(THR202 TYR204) and CaMKII(THR286)
Time frame: Baseline and 12 weeks
Change in skeletal muscle PPARs content
Time frame: Baseline and 12 weeks
Change in body composition
Time frame: Baseline, 6 and 12 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 2017.
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 Omega-3 Complete in people with Whole Body and Skeletal Muscle Energy Metabolism, run by University of Guelph at 1 site in Canada.
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 3 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 2017. 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 Canada. 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?
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?
Change in skeletal muscle whole muscle membrane fatty acid composition from baseline (time frame: Baseline and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2017.