<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/NCT02235805</url>
  </required_header>
  <id_info>
    <org_study_id>MEC 14-3-021</org_study_id>
    <nct_id>NCT02235805</nct_id>
  </id_info>
  <brief_title>Magnesium and Vascular Stiffness</brief_title>
  <official_title>The Effects of Magnesium on Vascular Stiffness: A Long-term Study in Healthy Overweight and Slightly Obese Men and Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Top Institute Food and Nutrition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observational epidemiologic studies have observed an inverse relationship between daily&#xD;
      dietary magnesium intake and blood pressure (BP). Except for BP, magnesium may also&#xD;
      beneficially affect other cardiovascular risk markers. Whether all these effects translate&#xD;
      into improved vascular function is not known. Different vascular function markers at various&#xD;
      stages on the pathway between diet and disease exist. One of these markers, vascular&#xD;
      stiffness, is closely related to the process of atherosclerosis, an independent&#xD;
      cardiovascular risk factor, and predictive of future cardiovascular events and mortality. To&#xD;
      examine the integrated effects of interventions on cardiovascular risk, vascular stiffness&#xD;
      may therefore serve as a marker at the later stage of cardiovascular disease development.&#xD;
&#xD;
      Therefore, it is imperative to examine in a 24-week, randomized, double-blind,&#xD;
      placebo-controlled, two-way parallel-group human intervention study, the effect of magnesium&#xD;
      on vascular stiffness. Focus will be on carotid-femoral pulse wave velocity (PWV), the gold&#xD;
      standard for the evaluation of vascular elasticity, to quantify vascular stiffness. Urinary&#xD;
      excretion of magnesium will be used to assess dietary magnesium uptake. Furthermore, time&#xD;
      courses of an increased magnesium intake on changes in BP, other markers reflecting vascular&#xD;
      function, and plasma biomarkers related to low-grade inflammation and vascular activity will&#xD;
      be measured to unravel possible cause-effect relationships.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vascular stiffness: effects of magnesium citrate supplementation</measure>
    <time_frame>Baseline (0 weeks) and after medium-term (12 weeks) and long-term (24 weeks) magnesium citrate supplementation</time_frame>
    <description>Carotid-femoral pulse wave velocity (PWV)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vascular function markers: effects of magnesium citrate supplementation</measure>
    <time_frame>Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation</time_frame>
    <description>Flow-mediated dilation (FMD) of the brachial artery, pulse wave analysis (PWA) (also at 12 weeks), peripheral arterial tonometry (PAT) and retinal microvascular diameters (also at 12 weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic risk markers related to the metabolic syndrome: effects of magnesium citrate supplementation</measure>
    <time_frame>Baseline (0 weeks) and after medium-term (12 weeks) and long-term (24 weeks) magnesium citrate supplementation</time_frame>
    <description>Biomarkers for low-grade inflammation and endothelial activation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure: effects of magnesium citrate supplementation</measure>
    <time_frame>Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation</time_frame>
    <description>Office (also at 12 weeks) and 24-hour ambulatory blood pressure</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Dietary magnesium uptake</measure>
    <time_frame>Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation</time_frame>
    <description>24-hour urine samples</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Metabolic Syndrome</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Magnesium Citrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Magnesium Citrate</intervention_name>
    <description>One capsule thrice daily that contains magnesium citrate (total daily dose: 350 mg elemental magnesium) at breakfast, lunch and dinner for 24 weeks</description>
    <arm_group_label>Magnesium Citrate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>One capsule thrice daily that contains placebo at breakfast, lunch and dinner for 24 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 45-70 years&#xD;
&#xD;
          -  Women postmenopausal: two or more years after last menstruation&#xD;
&#xD;
          -  BMI between 25-35 kg/m2 (overweight and slightly obese)&#xD;
&#xD;
          -  Plasma glucose &lt; 7.0 mmol/L&#xD;
&#xD;
          -  Serum total cholesterol &lt; 8.0 mmol/L&#xD;
&#xD;
          -  Serum triacylglycerol &lt; 4.5 mmol/L&#xD;
&#xD;
          -  No current smoker&#xD;
&#xD;
          -  No diabetic patients&#xD;
&#xD;
          -  No familial hypercholesterolemia&#xD;
&#xD;
          -  No abuse of drugs&#xD;
&#xD;
          -  Less than 21 alcoholic consumptions per week&#xD;
&#xD;
          -  Stable body weight (weight gain or loss &lt; 3 kg in the past three months)&#xD;
&#xD;
          -  No use of proton pump inhibitors or medication known to treat blood pressure, serum&#xD;
             lipid or glucose metabolism&#xD;
&#xD;
          -  No use of dietary supplements or an investigational product within another biomedical&#xD;
             within the previous 1-month&#xD;
&#xD;
          -  No severe medical conditions that might interfere with the study, such as epilepsy,&#xD;
             asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease,&#xD;
             inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis&#xD;
&#xD;
          -  No active cardiovascular disease like congestive heart failure or cardiovascular&#xD;
             event, such as an acute myocardial infarction or cerebro vascular accident&#xD;
&#xD;
          -  Willingness to give up being a blood donor (or having donated blood) from 8 weeks&#xD;
             before the start of the study and during the study&#xD;
&#xD;
          -  No difficult venipuncture as evidenced during the screening visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  High habitual dietary magnesium intake&#xD;
&#xD;
          -  Plasma glucose ≥ 7.0 mmol/L&#xD;
&#xD;
          -  Serum total cholesterol ≥ 8.0 mmol/L&#xD;
&#xD;
          -  Serum triacylglycerol ≥ 4.5 mmol/L&#xD;
&#xD;
          -  Current smoker, or smoking cessation &lt; 12 months&#xD;
&#xD;
          -  Diabetic patients&#xD;
&#xD;
          -  Familial hypercholesterolemia&#xD;
&#xD;
          -  Abuse of drugs&#xD;
&#xD;
          -  More than 21 alcoholic consumptions per week&#xD;
&#xD;
          -  Unstable body weight (weight gain or loss &gt; 3 kg in the past three months)&#xD;
&#xD;
          -  Use of proton pump inhibitors or medication known to treat blood pressure, serum lipid&#xD;
             or glucose metabolism&#xD;
&#xD;
          -  Use of dietary supplements or an investigational product within another biomedical&#xD;
             within the previous 1-month&#xD;
&#xD;
          -  Severe medical conditions that might interfere with the study, such as epilepsy,&#xD;
             asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease,&#xD;
             inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis&#xD;
&#xD;
          -  Active cardiovascular disease like congestive heart failure or cardiovascular event,&#xD;
             such as an acute myocardial infarction or cerebro vascular accident&#xD;
&#xD;
          -  Not willing to give up being a blood donor (or having donated blood) from 8 weeks&#xD;
             before the start of the study and during the study&#xD;
&#xD;
          -  Not or difficult to venipuncture as evidenced during the screening visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ronald P Mensink, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>September 14, 2015</last_update_submitted>
  <last_update_submitted_qc>September 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Metabolic Syndrome</keyword>
  <keyword>Obesity</keyword>
  <keyword>Magnesium Supplementation</keyword>
  <keyword>Vascular Stiffness</keyword>
  <keyword>Vascular Function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium citrate</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02235805
org study id: MEC 14-3-021
nct id: NCT02235805
lead sponsor: 
collaborator: 
has dmc: No
Observational epidemiologic studies have observed an inverse relationship between daily
      dietary magnesium intake and blood pressure (BP). Except for BP, magnesium may also
      beneficially affect other cardiovascular risk markers. Whether all these effects translate
      into improved vascular function is not known. Different vascular function markers at various
      stages on the pathway between diet and disease exist. One of these markers, vascular
      stiffness, is closely related to the process of atherosclerosis, an independent
      cardiovascular risk factor, and predictive of future cardiovascular events and mortality. To
      examine the integrated effects of interventions on cardiovascular risk, vascular stiffness
      may therefore serve as a marker at the later stage of cardiovascular disease development.

      Therefore, it is imperative to examine in a 24-week, randomized, double-blind,
      placebo-controlled, two-way parallel-group human intervention study, the effect of magnesium
      on vascular stiffness. Focus will be on carotid-femoral pulse wave velocity (PWV), the gold
      standard for the evaluation of vascular elasticity, to quantify vascular stiffness. Urinary
      excretion of magnesium will be used to assess dietary magnesium uptake. Furthermore, time
      courses of an increased magnesium intake on changes in BP, other markers reflecting vascular
      function, and plasma biomarkers related to low-grade inflammation and vascular activity will
      be measured to unravel possible cause-effect relationships.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Vascular stiffness: effects of magnesium citrate supplementation
time frame: Baseline (0 weeks) and after medium-term (12 weeks) and long-term (24 weeks) magnesium citrate supplementation
description: Carotid-femoral pulse wave velocity (PWV)
measure: Vascular function markers: effects of magnesium citrate supplementation
time frame: Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation
description: Flow-mediated dilation (FMD) of the brachial artery, pulse wave analysis (PWA) (also at 12 weeks), peripheral arterial tonometry (PAT) and retinal microvascular diameters (also at 12 weeks)
measure: Metabolic risk markers related to the metabolic syndrome: effects of magnesium citrate supplementation
time frame: Baseline (0 weeks) and after medium-term (12 weeks) and long-term (24 weeks) magnesium citrate supplementation
description: Biomarkers for low-grade inflammation and endothelial activation
measure: Blood pressure: effects of magnesium citrate supplementation
time frame: Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation
description: Office (also at 12 weeks) and 24-hour ambulatory blood pressure
measure: Dietary magnesium uptake
time frame: Baseline (0 weeks) and after long-term (24 weeks) magnesium citrate supplementation
description: 24-hour urine samples
arm group label: Magnesium Citrate
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Magnesium Citrate
description: One capsule thrice daily that contains magnesium citrate (total daily dose: 350 mg elemental magnesium) at breakfast, lunch and dinner for 24 weeks
arm group label: Magnesium Citrate
intervention type: Dietary Supplement
intervention name: Placebo
description: One capsule thrice daily that contains placebo at breakfast, lunch and dinner for 24 weeks
arm group label: Placebo
criteria: 
gender: All
minimum age: 45 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ronald P Mensink, PhD
role: Principal Investigator
affiliation: Maastricht University Medical Center
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Magnesium citrate