<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/NCT03018496</url>
  </required_header>
  <id_info>
    <org_study_id>A12092016- ammendment 1</org_study_id>
    <nct_id>NCT03018496</nct_id>
  </id_info>
  <brief_title>Investigating the Effects of Beta-Hydroxy-Beta-Methylbutyrate on Glucose Handling in Older and Younger Men.</brief_title>
  <official_title>Investigating the Effects of Beta-Hydroxy-Beta-Methylbutyrate on Glucose Handling in Older and Younger Men.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study intends to examine the effect of a commercially available nutritional supplement,&#xD;
      Beta-hydroxy-beta-methylbutyrate(HMB) on whole-body responses to a sugar load.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One change associated with human aging is a reduction in &quot;fitness&quot;, both in terms of how far&#xD;
      or quickly a person can run/cycle/swim and also in how well their blood vessels work.&#xD;
      Additionally a person's metabolic fitness decreases; this is how well the body copes with&#xD;
      nutrition and is why, for example, older people have a higher risk of diseases like type 2&#xD;
      diabetes. Previous studies have shown that as people become less fit, they are at increased&#xD;
      risk of suffering a complication whilst undergoing surgery. It has also been shown that&#xD;
      measuring how fit someone is, is better at predicting the risk of a surgical complication&#xD;
      than purely using a person's age alone. Lots of research has shown that exercise can&#xD;
      potentially reverse some of the age-related declines in fitness, however most has used long&#xD;
      sessions of continuous exercise over a long period of time. High-intensity interval training&#xD;
      (HIT), whereby people cycle on an exercise bike very hard for a minute, followed by a short&#xD;
      rest, repeated over the course of 15 minutes can rapidly improve a person's fitness. However&#xD;
      not everyone will be able to, or indeed want to participate in exercise this strenuous;&#xD;
      therefore this research seeks to explore whether other options, such as dietary supplements&#xD;
      can improve aspects of fitness&#xD;
&#xD;
      This study intends to examine the effect of giving a dietary supplement on the way a person's&#xD;
      body handles the glucose (from carbohydrates/ sugars) in a meal. Previous work has shown that&#xD;
      taking a beta-hydroxy beta-methyl butyrate (HMB) supplement may improve may improve a&#xD;
      patient's response to glucose, however the evidence is not clear. HMB is a commercially&#xD;
      available nutritional supplement providing a compound that the body produces each time&#xD;
      protein is consumed, and is most commonly used by bodybuilders to help gain muscle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Matsuda Index of insulin sensitivity</measure>
    <time_frame>180 minutes after a 75g oral glucose load</time_frame>
    <description>Assessed from arterialised venous blood samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cederholm index of insulin sensitivity</measure>
    <time_frame>180 minutes after a 75g oral glucose load</time_frame>
    <description>Assessed from arterialised venous blood samples</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area-Under-Curve Glucose Concentration</measure>
    <time_frame>180 minutes after a 75g oral glucose load</time_frame>
    <description>Assessed from arterialised venous blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area-Under-Curve Insulin Concentration</measure>
    <time_frame>180 minutes after a 75g oral glucose load</time_frame>
    <description>Assessed from arterialised venous blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Femoral Artery Blood flow</measure>
    <time_frame>15 minutes, 60 minutes and 120 minutes after a 75g oral glucose load</time_frame>
    <description>Assessed using duplex ultrasonography of the superficial femoral artery of the right leg</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Insulin Resistance</condition>
  <condition>Age Problems</condition>
  <arm_group>
    <arm_group_label>Older Men</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy male adults aged 18-35 Subjects will receive both HMB and placebo on separate visits in a crossover fashion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Younger Men</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy male adults aged 65-85 Subjects will receive both HMB and placebo on separate visits in a crossover fashion</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Beta-Hydroxy-Beta-Methylbutyrate</intervention_name>
    <arm_group_label>Older Men</arm_group_label>
    <arm_group_label>Younger Men</arm_group_label>
    <other_name>HMB</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Older Men</arm_group_label>
    <arm_group_label>Younger Men</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers&#xD;
&#xD;
          -  Aged 18-35 or 65-85&#xD;
&#xD;
          -  Male&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current participation in a formal exercise regime&#xD;
&#xD;
          -  A BMI &lt; 18 or &gt; 32 kg·m2&#xD;
&#xD;
          -  Active cardiovascular disease:&#xD;
&#xD;
             o uncontrolled hypertension (BP &gt; 160/100), angina, heart failure (class III/IV),&#xD;
             Significant arrhythmia, right to left cardiac shunt, recent cardiac event&#xD;
&#xD;
          -  Taking beta-adrenergic blocking agents,&#xD;
&#xD;
          -  Cerebrovascular disease:&#xD;
&#xD;
             o previous stroke, aneurysm (large vessel or intracranial), epilepsy&#xD;
&#xD;
          -  Respiratory disease including:&#xD;
&#xD;
             o pulmonary hypertension, significant COPD, uncontrolled asthma,&#xD;
&#xD;
          -  Metabolic disease:&#xD;
&#xD;
             o hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's&#xD;
             disease, type 1 or 2 diabetes&#xD;
&#xD;
          -  Active inflammatory bowel or renal disease&#xD;
&#xD;
          -  Malignancy&#xD;
&#xD;
          -  Clotting dysfunction&#xD;
&#xD;
          -  Significant musculoskeletal or neurological disorders&#xD;
&#xD;
          -  Family history of early (&lt;55y) death from cardiovascular disease&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Of Nottingham</name>
      <address>
        <city>Derby</city>
        <zip>DE22 3NE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462.</citation>
    <PMID>10480510</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>March 8, 2019</last_update_submitted>
  <last_update_submitted_qc>March 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03018496
org study id: A12092016- ammendment 1
nct id: NCT03018496
lead sponsor: 
has dmc: No
This study intends to examine the effect of a commercially available nutritional supplement,
      Beta-hydroxy-beta-methylbutyrate(HMB) on whole-body responses to a sugar load.
One change associated with human aging is a reduction in "fitness", both in terms of how far
      or quickly a person can run/cycle/swim and also in how well their blood vessels work.
      Additionally a person's metabolic fitness decreases; this is how well the body copes with
      nutrition and is why, for example, older people have a higher risk of diseases like type 2
      diabetes. Previous studies have shown that as people become less fit, they are at increased
      risk of suffering a complication whilst undergoing surgery. It has also been shown that
      measuring how fit someone is, is better at predicting the risk of a surgical complication
      than purely using a person's age alone. Lots of research has shown that exercise can
      potentially reverse some of the age-related declines in fitness, however most has used long
      sessions of continuous exercise over a long period of time. High-intensity interval training
      (HIT), whereby people cycle on an exercise bike very hard for a minute, followed by a short
      rest, repeated over the course of 15 minutes can rapidly improve a person's fitness. However
      not everyone will be able to, or indeed want to participate in exercise this strenuous;
      therefore this research seeks to explore whether other options, such as dietary supplements
      can improve aspects of fitness

      This study intends to examine the effect of giving a dietary supplement on the way a person's
      body handles the glucose (from carbohydrates/ sugars) in a meal. Previous work has shown that
      taking a beta-hydroxy beta-methyl butyrate (HMB) supplement may improve may improve a
      patient's response to glucose, however the evidence is not clear. HMB is a commercially
      available nutritional supplement providing a compound that the body produces each time
      protein is consumed, and is most commonly used by bodybuilders to help gain muscle.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Matsuda Index of insulin sensitivity
time frame: 180 minutes after a 75g oral glucose load
description: Assessed from arterialised venous blood samples
measure: Cederholm index of insulin sensitivity
time frame: 180 minutes after a 75g oral glucose load
description: Assessed from arterialised venous blood samples
measure: Area-Under-Curve Glucose Concentration
time frame: 180 minutes after a 75g oral glucose load
description: Assessed from arterialised venous blood samples
measure: Area-Under-Curve Insulin Concentration
time frame: 180 minutes after a 75g oral glucose load
description: Assessed from arterialised venous blood samples
measure: Femoral Artery Blood flow
time frame: 15 minutes, 60 minutes and 120 minutes after a 75g oral glucose load
description: Assessed using duplex ultrasonography of the superficial femoral artery of the right leg
arm group label: Older Men
arm group type: Experimental
description: Healthy male adults aged 18-35 Subjects will receive both HMB and placebo on separate visits in a crossover fashion
arm group label: Younger Men
arm group type: Experimental
description: Healthy male adults aged 65-85 Subjects will receive both HMB and placebo on separate visits in a crossover fashion
intervention type: Dietary Supplement
intervention name: Beta-Hydroxy-Beta-Methylbutyrate
arm group label: Older Men
arm group label: Younger Men
other name: HMB
intervention type: Other
intervention name: Placebo
arm group label: Older Men
arm group label: Younger Men
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
citation: Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462.
PMID: 10480510
responsible party type: Sponsor
mesh term: Insulin Resistance
sharing ipd: No