Effect of 12 wk of Omega-3 FA Supplementation on Metabolic and Physical Health Parameters in Older Adults
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| ClinicalTrials.gov Identifier: NCT01734538 |
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Recruitment Status : Unknown
Verified November 2012 by Lawrence Spriet, University of Guelph.
Recruitment status was: Not yet recruiting
First Posted : November 27, 2012
Last Update Posted : November 27, 2012
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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 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Dietary Supplement: Omega-3 Complete |
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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
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Dietary Supplement: Placebo capsule |
- 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 ]
- 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 ]
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| Ages Eligible for Study: | 60 Years to 74 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734538
| Contact: Samantha Logan, MSc | 519-821-4120 ext 53907 | slogan01@uoguelph.ca |
| Canada, Ontario | |
| The University of Guelph | |
| Guelph, Ontario, Canada, N1G2W1 | |
| Principal Investigator: | Lawrence L. Spriet, PhD | The University of Guelph |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Lawrence Spriet, Dr. Lawrence Spriet, University of Guelph |
| ClinicalTrials.gov Identifier: | NCT01734538 |
| Other Study ID Numbers: |
12OC014 |
| First Posted: | November 27, 2012 Key Record Dates |
| Last Update Posted: | November 27, 2012 |
| Last Verified: | November 2012 |