Effect of Omega-3 Fatty Acid Supplementation Physical FitnessNCT01734538
Effect of 12 wk of Omega-3 FA Supplementation on Metabolic and Physical Health Parameters in Older Adults
A study testing Omega-3 Complete in people with Effect of Omega-3 Fatty Acid Supplementation Physical Fitness, run by University of Guelph at 1 site in Canada.
Trial summary
The biological membranes that surround a cell and its organelles are important to the overall function of the cell. Fatty acids are the main structural components of a membrane, and the presence of certain fatty acids can alter a membrane's characteristics, which subsequently alters its function. Read more about this study
- Who is it for?
- Ages 60 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Omega-3 Fatty Acid Supplementation Physical Fitness
- 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
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Nov 2013
- 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 to 74 years of age
- Community-dwelling
Who cannot join
- Current or previous supplementation with omega-3's
- Average fish intake greater than one time per week
- Diagnosed heart condition
- Lightheadeness, shortness of breath, chest pain, numbness, fatigue, coughing, or wheezing during rest or at low to moderate physical activity
- Cardiovascular disease risk factors: family history of heart attacks, hypertension, hypercholesterolemia, diabetes mellitus, and smoking
- Allergies to lidocaine, fish/fish oil, gelatin, glycerin, or mixed tocopherols
- Currently taking any medications or supplements that may increase the chance of bleeding (e.g. Aspirin, Coumadin, Anti-inflammatories, Plavix, Vitamin C or E, high doses of garlic, gingko biloba, willow bark products)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 12 Weeks of Omega-3 Fatty Acid Supplementation on Metabolic and Physical Health Parameters in Older Adults
The biological membranes that surround a cell and its organelles are important to the overall function of the cell. Fatty acids are the main structural components of a membrane, and the presence of certain fatty acids can alter a membrane's characteristics, which subsequently alters its function. Two fatty acids that are of particular interest to researchers are eicosapentanoic acid (EPA) and docosahexanoic acid (DHA). These omega-3 fatty acids have unique unsaturated structures, and their incorporation into biological membranes appears to elicit potent physiological effects. The body is unable to intrinsically synthesize these important fatty acids, so they must be obtained from the diet or through supplementation.
EPA and DHA supplementation has been reported to provide numerous positive health benefits, including decreased blood pressure and an improved blood lipid profile. Recent research in our laboratory has demonstrated in young men that resting metabolic rate was increased following a 12 week period of omega fatty acid supplementation of 3 g/day. Fat utilization was also increased and carbohydrate use was decreased both at rest and during a 1 hr moderate exercise challenge. These findings have positive implications for people who are interested in losing weight, but it not known whether these effects occur in older adults. With age, body composition changes (increase in fat mass and decrease in lean mass) occur which may negatively affect general health, particularly normal physical functioning and quality of living of the older adult. The potential role of omega 3 fatty acids to increase fat oxidation and increase resting metabolic rate may be a therapy for decreasing fat mass in the older adult. Research has suggested that omega 3 fatty acids may elicit an additional therapeutic role by reducing joint pain.
Read more
Another aspect of aging is a loss in lean body mass, which is associated with an attenuation of skeletal muscle protein synthesis in response to nutritional stimuli (amino acids and insulin). The weakened anabolic response is considered to be partly due to defects in the anabolic signaling cascade in the muscle. Research in older adults has reported an increase in muscle protein signaling with EPA and DHA supplementation in response to a nutritional challenge. However it is unknown whether the increase in protein signaling results in an eventual increase in lean body mass. The physical functioning of older adults is not only influenced by body composition changes, but also age-related neuronal changes that affect the velocity of axonal conduction and influence the ability of the muscle to generate torque and the rate at which the torque is developed. Muscular strength and functional capacity increases have been reported with chronic resistance exercise in a cohort of older women supplemented with EPA and DHA. However, the effect of EPA and DHA intake on physical strength in older adults with previously low EPA and DHA consumption, independent of exercise, is currently unknown.
Therefore, the purpose of this study is to determine the effects of 12 weeks of omega-3 supplementation at 3 g/day on metabolic and physical health parameters in community-dwelling older adults. We hypothesize that EPA and DHA supplementation will result in 1) a decrease in resting heart rate and blood pressure; 2) a more healthy blood profile; 3) an increase in resting metabolic rate; 4) a greater reliance on fat oxidation for energy both at rest and during exercise; and 5) a decrease in fat mass; and 6) an increase in lean mass, strength and physical function.
- Being tested
- Omega-3 Complete, Placebo capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 CompleteDietary supplement
Placebo capsuleDietary supplement
| 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 Capsule | Placebo comparator | Oral ingestion of 5 capsules of a placebo oil pill (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks Receives: Dietary Supplement: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resting heart rate from baseline
Measured: baseline and 12 weeks
Change in resting blood pressure from baseline
Measured: baseline to 12 weeks
Change in fasted blood triglyceride concentration from baseline
Measured: baseline to 12 weeks
Change in fasted blood cholesterol from baseline
Measured: baseline to 12 weeks
Change in blood c-reactive protein concentration from baseline
Measured: baseline to 12 weeks
Change in fasted blood low-density lipoprotein concentration from baseline
Measured: baseline to 12 weeks
change in fasted blood high-density lipoprotein concentration from baseline
Measured: baseline to 12 weeks
Change in fasted blood insulin concentration from baseline
Measured: baseline to 12 weeks
Change in fasted blood glucose concentration from baseline
Measured: baseline to 12 weeks
Change in whole body resting fat oxidation from baseline
Measured: baseline to 12 weeks
Change in whole body resting carbohydrate oxidation from baseline
Measured: baseline to 12 weeks
Change in whole body sub-maximal ecercise fat oxidation from baseline
Measured: baseline to 12 weeks
Change in whole body sub-maximal ecercise carbohydrate oxidation from baseline
Measured: baseline to 12 weeks
Change in resting metabolic rate from baseline
Measured: baseline to 12 weeks
Change in fat mass from baseline
Measured: baseline to 12 weeks
Change in lean mass from baseline
Measured: baseline to 12 weeks
Change in strength from baseline
Measured: baseline to 12 weeks
Change in physical function (balance) from baseline
Measured: baseline to 12 weeks
Secondary outcomes (2)
Change in self-reported pain from baseline
Measured: baseline to 12 weeks
Change in self-reported overall health from baseline
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Effect of Omega-3 Fatty Acid Supplementation Physical FitnessStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 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
- Investigators
- Lawrence L. Spriet, PhD, Principal investigator, The University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734538
- Sponsor's protocol ID
- 12OC014
- Status last verified
- Nov 2012
- First submitted
- 21 Nov 2012
- Last updated
- 27 Nov 2012
- Results posted
- No
Publications
Kiecolt-Glaser JK, Belury MA, Andridge R, Malarkey WB, Hwang BS, Glaser R. Omega-3 supplementation lowers inflammation in healthy middle-aged and older adults: a randomized controlled trial. Brain Behav Immun. 2012 Aug;26(6):988-95. doi: 10.1016/j.bbi.2012.05.011. Epub 2012 May 26.
PubMed 22640930Rodacki CL, Rodacki AL, Pereira G, Naliwaiko K, Coelho I, Pequito D, Fernandes LC. Fish-oil supplementation enhances the effects of strength training in elderly women. Am J Clin Nutr. 2012 Feb;95(2):428-36. doi: 10.3945/ajcn.111.021915. Epub 2012 Jan 4.
PubMed 22218156Smith GI, Atherton P, Reeds DN, Mohammed BS, Rankin D, Rennie MJ, Mittendorfer B. Dietary omega-3 fatty acid supplementation increases the rate of muscle protein synthesis in older adults: a randomized controlled trial. Am J Clin Nutr. 2011 Feb;93(2):402-12. doi: 10.3945/ajcn.110.005611. Epub 2010 Dec 15.
PubMed 21159787Couet C, Delarue J, Ritz P, Antoine JM, Lamisse F. Effect of dietary fish oil on body fat mass and basal fat oxidation in healthy adults. Int J Obes Relat Metab Disord. 1997 Aug;21(8):637-43. doi: 10.1038/sj.ijo.0800451.
PubMed 15481762Delarue J, Labarthe F, Cohen R. Fish-oil supplementation reduces stimulation of plasma glucose fluxes during exercise in untrained males. Br J Nutr. 2003 Oct;90(4):777-86. doi: 10.1079/bjn2003964.
PubMed 13129446Peoples GE, McLennan PL, Howe PR, Groeller H. Fish oil reduces heart rate and oxygen consumption during exercise. J Cardiovasc Pharmacol. 2008 Dec;52(6):540-7. doi: 10.1097/FJC.0b013e3181911913.
PubMed 19034030Calder PC. n-3 Fatty acids and cardiovascular disease: evidence explained and mechanisms explored. Clin Sci (Lond). 2004 Jul;107(1):1-11. doi: 10.1042/CS20040119.
PubMed 15132735Logan SL, Spriet LL. Omega-3 Fatty Acid Supplementation for 12 Weeks Increases Resting and Exercise Metabolic Rate in Healthy Community-Dwelling Older Females. PLoS One. 2015 Dec 17;10(12):e0144828. doi: 10.1371/journal.pone.0144828. eCollection 2015.
PubMed 26679702
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 12 Weeks of Omega-3 Fatty Acid Supplementation on Metabolic and Physical Health Parameters in Older Adults
- ClinicalTrials.gov ID
- NCT01734538
- Acronym / sponsor ID
- 12OC014
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 27 Nov 2012 (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.
The biological membranes that surround a cell and its organelles are important to the overall function of the cell. Fatty acids are the main structural components of a membrane, and the presence of certain fatty acids can alter a membrane's characteristics, which subsequently alters its function. Two fatty acids that are of particular interest to researchers are eicosapentanoic acid (EPA) and docosahexanoic acid (DHA). These omega-3 fatty acids have unique unsaturated structures, and their incorporation into biological membranes appears to elicit potent physiological effects. The body is unable to intrinsically synthesize these important fatty acids, so they must be obtained from the diet or through supplementation.
EPA and DHA supplementation has been reported to provide numerous positive health benefits, including decreased blood pressure and an improved blood lipid profile. Recent research in our laboratory has demonstrated in young men that resting metabolic rate was increased following a 12 week period of omega fatty acid supplementation of 3 g/day. Fat utilization was also increased and carbohydrate use was decreased both at rest and during a 1 hr moderate exercise challenge. These findings have positive implications for people who are interested in losing weight, but it not known whether these effects occur in older adults. With age, body composition changes (increase in fat mass and decrease in lean mass) occur which may negatively affect general health, particularly normal physical functioning and quality of living of the older adult. The potential role of omega 3 fatty acids to increase fat oxidation and increase resting metabolic rate may be a therapy for decreasing fat mass in the older adult. Research has suggested that omega 3 fatty acids may elicit an additional therapeutic role by reducing joint pain.
Another aspect of aging is a loss in lean body mass, which is associated with an attenuation of skeletal muscle protein synthesis in response to nutritional stimuli (amino acids and insulin). The weakened anabolic response is considered to be partly due to defects in the anabolic signaling cascade in the muscle. Research in older adults has reported an increase in muscle protein signaling with EPA and DHA supplementation in response to a nutritional challenge. However it is unknown whether the increase in protein signaling results in an eventual increase in lean body mass. The physical functioning of older adults is not only influenced by body composition changes, but also age-related neuronal changes that affect the velocity of axonal conduction and influence the ability of the muscle to generate torque and the rate at which the torque is developed. Muscular strength and functional capacity increases have been reported with chronic resistance exercise in a cohort of older women supplemented with EPA and DHA. However, the effect of EPA and DHA intake on physical strength in older adults with previously low EPA and DHA consumption, independent of exercise, is currently unknown.
Therefore, the purpose of this study is to determine the effects of 12 weeks of omega-3 supplementation at 3 g/day on metabolic and physical health parameters in community-dwelling older adults. We hypothesize that EPA and DHA supplementation will result in 1) a decrease in resting heart rate and blood pressure; 2) a more healthy blood profile; 3) an increase in resting metabolic rate; 4) a greater reliance on fat oxidation for energy both at rest and during exercise; and 5) a decrease in fat mass; and 6) an increase in lean mass, strength and physical function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- 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 Capsule | Placebo comparator | Dietary Supplement: Placebo capsuleOral ingestion of 5 capsules of a placebo oil pill (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60 to 74 years of age
- Community-dwelling
Key exclusion criteria (7 listed)
- Current or previous supplementation with omega-3's
- Average fish intake greater than one time per week
- Diagnosed heart condition
- Lightheadeness, shortness of breath, chest pain, numbness, fatigue, coughing, or wheezing during rest or at low to moderate physical activity
- Cardiovascular disease risk factors: family history of heart attacks, hypertension, hypercholesterolemia, diabetes mellitus, and smoking
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 Complete | Dietary supplement | Omega-3 Complete |
| Placebo capsule | Dietary supplement | Placebo Capsule |
Primary outcome
Change in resting heart rate from baseline
Time frame: baseline and 12 weeks
Change in resting blood pressure from baseline
Time frame: baseline to 12 weeks
Change in fasted blood triglyceride concentration from baseline
Time frame: baseline to 12 weeks
Change in fasted blood cholesterol from baseline
Time frame: baseline to 12 weeks
Change in blood c-reactive protein concentration from baseline
Time frame: baseline to 12 weeks
Change in fasted blood low-density lipoprotein concentration from baseline
Time frame: baseline to 12 weeks
change in fasted blood high-density lipoprotein concentration from baseline
Time frame: baseline to 12 weeks
Change in fasted blood insulin concentration from baseline
Time frame: baseline to 12 weeks
Change in fasted blood glucose concentration from baseline
Time frame: baseline to 12 weeks
Change in whole body resting fat oxidation from baseline
Time frame: baseline to 12 weeks
Change in whole body resting carbohydrate oxidation from baseline
Time frame: baseline to 12 weeks
Change in whole body sub-maximal ecercise fat oxidation from baseline
Time frame: baseline to 12 weeks
Change in whole body sub-maximal ecercise carbohydrate oxidation from baseline
Time frame: baseline to 12 weeks
Change in resting metabolic rate from baseline
Time frame: baseline to 12 weeks
Change in fat mass from baseline
Time frame: baseline to 12 weeks
Change in lean mass from baseline
Time frame: baseline to 12 weeks
Change in strength from baseline
Time frame: baseline to 12 weeks
Change in physical function (balance) from baseline
Time frame: baseline to 12 weeks
2 secondary outcomes
Change in self-reported pain from baseline
Time frame: baseline to 12 weeks
Change in self-reported overall health from baseline
Time frame: baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
- Background: PubMed 22640930Kiecolt-Glaser JK, Belury MA, Andridge R, Malarkey WB, Hwang BS, Glaser R. Omega-3 supplementation lowers inflammation in healthy middle-aged and older adults: a randomized controlled trial. Brain Behav Immun. 2012 Aug;26(6):988-95. doi: 10.1016/j.bbi.2012.05.011. Epub 2012 May 26.
- Background: PubMed 22218156Rodacki CL, Rodacki AL, Pereira G, Naliwaiko K, Coelho I, Pequito D, Fernandes LC. Fish-oil supplementation enhances the effects of strength training in elderly women. Am J Clin Nutr. 2012 Feb;95(2):428-36. doi: 10.3945/ajcn.111.021915. Epub 2012 Jan 4.
- Background: PubMed 21159787Smith GI, Atherton P, Reeds DN, Mohammed BS, Rankin D, Rennie MJ, Mittendorfer B. Dietary omega-3 fatty acid supplementation increases the rate of muscle protein synthesis in older adults: a randomized controlled trial. Am J Clin Nutr. 2011 Feb;93(2):402-12. doi: 10.3945/ajcn.110.005611. Epub 2010 Dec 15.
- Background: PubMed 15481762Couet C, Delarue J, Ritz P, Antoine JM, Lamisse F. Effect of dietary fish oil on body fat mass and basal fat oxidation in healthy adults. Int J Obes Relat Metab Disord. 1997 Aug;21(8):637-43. doi: 10.1038/sj.ijo.0800451.
- Background: PubMed 13129446Delarue J, Labarthe F, Cohen R. Fish-oil supplementation reduces stimulation of plasma glucose fluxes during exercise in untrained males. Br J Nutr. 2003 Oct;90(4):777-86. doi: 10.1079/bjn2003964.
- Background: PubMed 19034030Peoples GE, McLennan PL, Howe PR, Groeller H. Fish oil reduces heart rate and oxygen consumption during exercise. J Cardiovasc Pharmacol. 2008 Dec;52(6):540-7. doi: 10.1097/FJC.0b013e3181911913.
- Background: PubMed 15132735Calder PC. n-3 Fatty acids and cardiovascular disease: evidence explained and mechanisms explored. Clin Sci (Lond). 2004 Jul;107(1):1-11. doi: 10.1042/CS20040119.
- Derived from this study: PubMed 26679702Logan SL, Spriet LL. Omega-3 Fatty Acid Supplementation for 12 Weeks Increases Resting and Exercise Metabolic Rate in Healthy Community-Dwelling Older Females. PLoS One. 2015 Dec 17;10(12):e0144828. doi: 10.1371/journal.pone.0144828. eCollection 2015.
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.
Lawrence L. Spriet, PhD principal investigator
The University of Guelph
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 Effect of Omega-3 Fatty Acid Supplementation Physical Fitness, 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 7 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 27 Nov 2012. 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?
Contact Samantha Logan, MSc (519-821-4120 ext. 53907, slogan01@uoguelph.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in resting heart rate from baseline (time frame: baseline and 12 weeks). The study lists 18 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 NCT01734538, which also lists 8 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 27 Nov 2012.