<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01734538</url>
  </required_header>
  <id_info>
    <org_study_id>12OC014</org_study_id>
    <nct_id>NCT01734538</nct_id>
  </id_info>
  <brief_title>Effect of 12 wk of Omega-3 FA Supplementation on Metabolic and Physical Health Parameters in Older Adults</brief_title>
  <official_title>Effects of 12 Weeks of Omega-3 Fatty Acid Supplementation on Metabolic and Physical Health Parameters in Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Guelph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Guelph</source>
  <brief_summary>
    <textblock>
      The biological membranes that surround a cell and its organelles are important to the overall&#xD;
      function of the cell. Fatty acids are the main structural components of a membrane, and the&#xD;
      presence of certain fatty acids can alter a membrane's characteristics, which subsequently&#xD;
      alters its function. Two fatty acids that are of particular interest to researchers are&#xD;
      eicosapentanoic acid (EPA) and docosahexanoic acid (DHA). These omega-3 fatty acids have&#xD;
      unique unsaturated structures, and their incorporation into biological membranes appears to&#xD;
      elicit potent physiological effects. The body is unable to intrinsically synthesize these&#xD;
      important fatty acids, so they must be obtained from the diet or through supplementation.&#xD;
&#xD;
      EPA and DHA supplementation has been reported to provide numerous positive health benefits,&#xD;
      including decreased blood pressure and an improved blood lipid profile. Recent research in&#xD;
      our laboratory has demonstrated in young men that resting metabolic rate was increased&#xD;
      following a 12 week period of omega fatty acid supplementation of 3 g/day. Fat utilization&#xD;
      was also increased and carbohydrate use was decreased both at rest and during a 1 hr moderate&#xD;
      exercise challenge. These findings have positive implications for people who are interested&#xD;
      in losing weight, but it not known whether these effects occur in older adults. With age,&#xD;
      body composition changes (increase in fat mass and decrease in lean mass) occur which may&#xD;
      negatively affect general health, particularly normal physical functioning and quality of&#xD;
      living of the older adult. The potential role of omega 3 fatty acids to increase fat&#xD;
      oxidation and increase resting metabolic rate may be a therapy for decreasing fat mass in the&#xD;
      older adult. Research has suggested that omega 3 fatty acids may elicit an additional&#xD;
      therapeutic role by reducing joint pain.&#xD;
&#xD;
      Another aspect of aging is a loss in lean body mass, which is associated with an attenuation&#xD;
      of skeletal muscle protein synthesis in response to nutritional stimuli (amino acids and&#xD;
      insulin). The weakened anabolic response is considered to be partly due to defects in the&#xD;
      anabolic signaling cascade in the muscle. Research in older adults has reported an increase&#xD;
      in muscle protein signaling with EPA and DHA supplementation in response to a nutritional&#xD;
      challenge. However it is unknown whether the increase in protein signaling results in an&#xD;
      eventual increase in lean body mass. The physical functioning of older adults is not only&#xD;
      influenced by body composition changes, but also age-related neuronal changes that affect the&#xD;
      velocity of axonal conduction and influence the ability of the muscle to generate torque and&#xD;
      the rate at which the torque is developed. Muscular strength and functional capacity&#xD;
      increases have been reported with chronic resistance exercise in a cohort of older women&#xD;
      supplemented with EPA and DHA. However, the effect of EPA and DHA intake on physical strength&#xD;
      in older adults with previously low EPA and DHA consumption, independent of exercise, is&#xD;
      currently unknown.&#xD;
&#xD;
      Therefore, the purpose of this study is to determine the effects of 12 weeks of omega-3&#xD;
      supplementation at 3 g/day on metabolic and physical health parameters in community-dwelling&#xD;
      older adults. We hypothesize that EPA and DHA supplementation will result in 1) a decrease in&#xD;
      resting heart rate and blood pressure; 2) a more healthy blood profile; 3) an increase in&#xD;
      resting metabolic rate; 4) a greater reliance on fat oxidation for energy both at rest and&#xD;
      during exercise; and 5) a decrease in fat mass; and 6) an increase in lean mass, strength and&#xD;
      physical function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">November 2013</completion_date>
  <primary_completion_date type="Anticipated">November 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in resting heart rate from baseline</measure>
    <time_frame>baseline and 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in resting blood pressure from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fasted blood triglyceride concentration from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fasted blood cholesterol from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in blood c-reactive protein concentration from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fasted blood low-density lipoprotein concentration from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>change in fasted blood high-density lipoprotein concentration from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fasted blood insulin concentration from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fasted blood glucose concentration from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in whole body resting fat oxidation from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in whole body resting carbohydrate oxidation from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in whole body sub-maximal ecercise fat oxidation from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in whole body sub-maximal ecercise carbohydrate oxidation from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in resting metabolic rate from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fat mass from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in lean mass from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in strength from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in physical function (balance) from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported pain from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported overall health from baseline</measure>
    <time_frame>baseline to 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Effect of Omega-3 Fatty Acid Supplementation Physical Fitness</condition>
  <arm_group>
    <arm_group_label>Omega-3 Complete</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories, Ltd., Windsor, Ontario, Canada) per day for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral ingestion of 5 capsules of a placebo oil pill (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Omega-3 Complete</intervention_name>
    <arm_group_label>Omega-3 Complete</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo capsule</intervention_name>
    <arm_group_label>Placebo Capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  60 to 74 years of age&#xD;
&#xD;
          -  Community-dwelling&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or previous supplementation with omega-3's&#xD;
&#xD;
          -  Average fish intake greater than one time per week&#xD;
&#xD;
          -  Diagnosed heart condition&#xD;
&#xD;
          -  Lightheadeness, shortness of breath, chest pain, numbness, fatigue, coughing, or&#xD;
             wheezing during rest or at low to moderate physical activity&#xD;
&#xD;
          -  Cardiovascular disease risk factors: family history of heart attacks, hypertension,&#xD;
             hypercholesterolemia, diabetes mellitus, and smoking&#xD;
&#xD;
          -  Allergies to lidocaine, fish/fish oil, gelatin, glycerin, or mixed tocopherols&#xD;
&#xD;
          -  Currently taking any medications or supplements that may increase the chance of&#xD;
             bleeding (e.g. Aspirin, Coumadin, Anti-inflammatories, Plavix, Vitamin C or E, high&#xD;
             doses of garlic, gingko biloba, willow bark products)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lawrence L. Spriet, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Guelph</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Samantha Logan, MSc</last_name>
    <phone>519-821-4120</phone>
    <phone_ext>53907</phone_ext>
    <email>slogan01@uoguelph.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>The University of Guelph</name>
      <address>
        <city>Guelph</city>
        <state>Ontario</state>
        <zip>N1G2W1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>22640930</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22218156</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21159787</PMID>
  </reference>
  <reference>
    <citation>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. doi: 10.1038/sj.ijo.0800451.</citation>
    <PMID>15481762</PMID>
  </reference>
  <reference>
    <citation>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. doi: 10.1079/bjn2003964.</citation>
    <PMID>13129446</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19034030</PMID>
  </reference>
  <reference>
    <citation>Calder 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.</citation>
    <PMID>15132735</PMID>
  </reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>November 26, 2012</last_update_submitted>
  <last_update_submitted_qc>November 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 27, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Guelph</investigator_affiliation>
    <investigator_full_name>Lawrence Spriet</investigator_full_name>
    <investigator_title>Dr. Lawrence Spriet</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01734538
org study id: 12OC014
nct id: NCT01734538
lead sponsor: 
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change in resting heart rate from baseline
time frame: baseline and 12 weeks
measure: Change in resting blood pressure from baseline
time frame: baseline to 12 weeks
measure: Change in fasted blood triglyceride concentration from baseline
time frame: baseline to 12 weeks
measure: Change in fasted blood cholesterol from baseline
time frame: baseline to 12 weeks
measure: Change in blood c-reactive protein concentration from baseline
time frame: baseline to 12 weeks
measure: Change in fasted blood low-density lipoprotein concentration from baseline
time frame: baseline to 12 weeks
measure: change in fasted blood high-density lipoprotein concentration from baseline
time frame: baseline to 12 weeks
measure: Change in fasted blood insulin concentration from baseline
time frame: baseline to 12 weeks
measure: Change in fasted blood glucose concentration from baseline
time frame: baseline to 12 weeks
measure: Change in whole body resting fat oxidation from baseline
time frame: baseline to 12 weeks
measure: Change in whole body resting carbohydrate oxidation from baseline
time frame: baseline to 12 weeks
measure: Change in whole body sub-maximal ecercise fat oxidation from baseline
time frame: baseline to 12 weeks
measure: Change in whole body sub-maximal ecercise carbohydrate oxidation from baseline
time frame: baseline to 12 weeks
measure: Change in resting metabolic rate from baseline
time frame: baseline to 12 weeks
measure: Change in fat mass from baseline
time frame: baseline to 12 weeks
measure: Change in lean mass from baseline
time frame: baseline to 12 weeks
measure: Change in strength from baseline
time frame: baseline to 12 weeks
measure: Change in physical function (balance) from baseline
time frame: baseline to 12 weeks
measure: Change in self-reported pain from baseline
time frame: baseline to 12 weeks
measure: Change in self-reported overall health from baseline
time frame: baseline to 12 weeks
arm group label: Omega-3 Complete
arm group type: Experimental
description: Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories, Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
arm group label: Placebo Capsule
arm group type: Placebo Comparator
description: Oral ingestion of 5 capsules of a placebo oil pill (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks
intervention type: Dietary Supplement
intervention name: Omega-3 Complete
arm group label: Omega-3 Complete
intervention type: Dietary Supplement
intervention name: Placebo capsule
arm group label: Placebo Capsule
criteria: 
gender: All
minimum age: 60 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lawrence L. Spriet, PhD
role: Principal Investigator
affiliation: The University of Guelph
last name: Samantha Logan, MSc
phone: 519-821-4120
phone ext: 53907
email: slogan01@uoguelph.ca
facility: 
country: Canada
citation: 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.
PMID: 22640930
citation: 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.
PMID: 22218156
citation: 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.
PMID: 21159787
citation: 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. doi: 10.1038/sj.ijo.0800451.
PMID: 15481762
citation: 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. doi: 10.1079/bjn2003964.
PMID: 13129446
citation: 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.
PMID: 19034030
citation: Calder 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.
PMID: 15132735
responsible party type: Principal Investigator
investigator affiliation: University of Guelph
investigator full name: Lawrence Spriet
investigator title: Dr. Lawrence Spriet