Effect of 12 wk of Omega-3 FA Supplementation on Metabolic and Physical Health Parameters in Older Adults

Study Description

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Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Effect of Omega-3 Fatty Acid Supplementation Physical Fitness	Dietary Supplement: Omega-3 Complete; Dietary Supplement: Placebo capsule	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Basic Science
Official Title:	Effects of 12 Weeks of Omega-3 Fatty Acid Supplementation on Metabolic and Physical Health Parameters in Older Adults
Study Start Date :	November 2012
Estimated Primary Completion Date :	November 2013
Estimated Study Completion Date :	November 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Omega-3 Complete; Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories, Ltd., Windsor, Ontario, Canada) per day for 12 weeks.	Dietary Supplement: Omega-3 Complete
Placebo Comparator: Placebo Capsule; Oral ingestion of 5 capsules of a placebo oil pill (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks	Dietary Supplement: Placebo capsule

Outcome Measures

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Primary Outcome Measures :

1. Change in resting heart rate from baseline [ Time Frame: baseline and 12 weeks ]
2. Change in resting blood pressure from baseline [ Time Frame: baseline to 12 weeks ]
3. Change in fasted blood triglyceride concentration from baseline [ Time Frame: baseline to 12 weeks ]
4. Change in fasted blood cholesterol from baseline [ Time Frame: baseline to 12 weeks ]
5. Change in blood c-reactive protein concentration from baseline [ Time Frame: baseline to 12 weeks ]
6. Change in fasted blood low-density lipoprotein concentration from baseline [ Time Frame: baseline to 12 weeks ]
7. change in fasted blood high-density lipoprotein concentration from baseline [ Time Frame: baseline to 12 weeks ]
8. Change in fasted blood insulin concentration from baseline [ Time Frame: baseline to 12 weeks ]
9. Change in fasted blood glucose concentration from baseline [ Time Frame: baseline to 12 weeks ]
10. Change in whole body resting fat oxidation from baseline [ Time Frame: baseline to 12 weeks ]
11. Change in whole body resting carbohydrate oxidation from baseline [ Time Frame: baseline to 12 weeks ]
12. Change in whole body sub-maximal ecercise fat oxidation from baseline [ Time Frame: baseline to 12 weeks ]
13. Change in whole body sub-maximal ecercise carbohydrate oxidation from baseline [ Time Frame: baseline to 12 weeks ]
14. Change in resting metabolic rate from baseline [ Time Frame: baseline to 12 weeks ]
15. Change in fat mass from baseline [ Time Frame: baseline to 12 weeks ]
16. Change in lean mass from baseline [ Time Frame: baseline to 12 weeks ]
17. Change in strength from baseline [ Time Frame: baseline to 12 weeks ]
18. Change in physical function (balance) from baseline [ Time Frame: baseline to 12 weeks ]

Secondary Outcome Measures :

1. Change in self-reported pain from baseline [ Time Frame: baseline to 12 weeks ]
2. Change in self-reported overall health from baseline [ Time Frame: baseline to 12 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	60 Years to 74 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• 60 to 74 years of age
• Community-dwelling

Exclusion Criteria:

• 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)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Samantha Logan, MSc	519-821-4120 ext 53907	slogan01@uoguelph.ca

Locations

Canada, Ontario
The University of Guelph	Not yet recruiting
Guelph, Ontario, Canada, N1G2W1

Sponsors and Collaborators

University of Guelph

Investigators

Principal Investigator:	Lawrence L. Spriet, PhD	The University of Guelph

More Information

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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.

Rodacki 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.

Smith 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.

Couet 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.

Delarue 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.

Peoples 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.

Calder PC. n-3 Fatty acids and cardiovascular disease: evidence explained and mechanisms explored. Clin Sci (Lond). 2004 Jul;107(1):1-11. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Logan 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.

Responsible Party:	Lawrence Spriet, Dr. Lawrence Spriet, University of Guelph
ClinicalTrials.gov Identifier:	NCT01734538 History of Changes
Other Study ID Numbers:	12OC014
First Posted:	November 27, 2012
Last Update Posted:	November 27, 2012
Last Verified:	November 2012