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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by University of Guelph
Sponsor:
Information provided by (Responsible Party):
Lawrence Spriet, University of Guelph
ClinicalTrials.gov Identifier:
NCT01734538
First received: November 21, 2012
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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 Intervention
Effect of Omega-3 Fatty Acid Supplementation Physical Fitness
Dietary Supplement: Omega-3 Complete
Dietary Supplement: Placebo capsule

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by University of Guelph:

Primary Outcome Measures:
  • Change in resting heart rate from baseline [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in resting blood pressure from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Change in fasted blood triglyceride concentration from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Change in fasted blood cholesterol from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Change in blood c-reactive protein concentration from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Change in fasted blood low-density lipoprotein concentration from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • change in fasted blood high-density lipoprotein concentration from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Change in fasted blood insulin concentration from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Change in fasted blood glucose concentration from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Change in whole body resting fat oxidation from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Change in whole body resting carbohydrate oxidation from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Change in whole body sub-maximal ecercise fat oxidation from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Change in whole body sub-maximal ecercise carbohydrate oxidation from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Change in resting metabolic rate from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Change in fat mass from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Change in lean mass from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Change in strength from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Change in physical function (balance) from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in self-reported pain from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Change in self-reported overall health from baseline [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years to 74 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734538

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

Publications:

Responsible Party: Lawrence Spriet, Dr. Lawrence Spriet, University of Guelph
ClinicalTrials.gov Identifier: NCT01734538     History of Changes
Other Study ID Numbers: 12OC014
Study First Received: November 21, 2012
Last Updated: November 26, 2012
Health Authority: Canada: Research Ethics Board

ClinicalTrials.gov processed this record on September 22, 2014