xml: <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/NCT05995522</url>
    </required_header>
    <id_info>
      <org_study_id>CI-00421</org_study_id>
      <nct_id>NCT05995522</nct_id>
    </id_info>
    <brief_title>Effect of Vitamin K2 Over Osteocalcin, Leptin, Cytokines, and Cardiovascular Risk in Young Adults With Overweight and Obesity</brief_title>
    <official_title>Effect of Vitamin K2 Supplementation and Its Association With Osteocalcin Serum Levels, Leptin, Th1/Th2 Cytokine Profile, and Cardiovascular Risk in Young Mexican Adults With Overweight and Obesity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Guadalajara</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Guadalajara</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare de effect of vitamin K2 in young adults with&#xD;
        overweight or obesity. The main questions to answer are:&#xD;
  &#xD;
        What is the effect of Vitamin K2 supplementation on methylation, serum concentration of ucOC,&#xD;
        cOC, Gas6, leptin, inflammatory markers, cardiometabolic risk factors, and cardiovascular&#xD;
        risk in overweight or obese young adults? Participants will be assigned to one of two&#xD;
        intervention groups where they will consume Vitamin K2 100 µg per day or cornstarch 500 mg&#xD;
        per day for 90 days.&#xD;
  &#xD;
        If there is a comparison group: Investigators will compare the supplementation group (Vitamin&#xD;
        K2) with the placebo group (cornstarch) to see if vitamin K2 supplementation modifies&#xD;
        methylation, increases serum vitamin K, osteocalcin, growth arrest-specific 6 protein serum&#xD;
        concentration, decreases serum leptin concentration, inflammatory markers and reduces&#xD;
        cardiometabolic risk factors and cardiovascular risk.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study Overview To meet the objectives of the project, two groups will be compared, one that&#xD;
        will be supplemented with vitamin K and another of patients who will receive corn starch as a&#xD;
        placebo. Patients are going to have a follow up during 3 months with periodic evaluations&#xD;
        every 30 days.&#xD;
  &#xD;
        This is a double-blind study, it is achieved by maintaining similarities in appearance, taste&#xD;
        and smell between the treatments that will be delivered in the same vials, with same number&#xD;
        of pills and identical in shape, color and consistency for each study group.&#xD;
  &#xD;
        Patient recruitment will take place by disseminating information through physical and social&#xD;
        media, once potential participants have been identified, they will be contacted and informed&#xD;
        about the project, and if they decide to participate in the study, they will be asked to sign&#xD;
        the informed consent.&#xD;
  &#xD;
        Simple randomization will be performed using R software to assign participants to one of the&#xD;
        study groups. A clinical history, anthropometric measurements and blood sampling shall be&#xD;
        applied.&#xD;
  &#xD;
        Nutritional recommendations based on the position of the Academy of Nutrition and Dietetics&#xD;
        for the treatment of overweight and obesity and the healthy eating plate of Harvard&#xD;
        University will be given. An appointment is to be scheduled every 30 days in order to provide&#xD;
        the supplementation and follow-up. At the end, the pertinent statistical analyzes will be&#xD;
        carried out.&#xD;
  &#xD;
        Notification of adverse effects will be made in each of the sessions, in addition to this the&#xD;
        participants will have the contact of the researchers to notify any anomaly.&#xD;
  &#xD;
        Sample's size calculation&#xD;
  &#xD;
        The sample size was calculated using the statistical formula for the comparison of two means.&#xD;
        This estimate was made using the following formula:&#xD;
  &#xD;
        n=2(Zα+Z[1-β]2xSD2/d2&#xD;
  &#xD;
        Where:&#xD;
  &#xD;
        n= sample size required in each group SD= standard deviation of the effect Zα: to the value&#xD;
        of Z for a confidence level of 95% Z[1-β}: to the value of Z for a statistical power of 80%&#xD;
        D= effect size A total of 19.72 patients per group were obtained. Considering a 20% loss, 24&#xD;
        patients are needed per study group.&#xD;
  &#xD;
        Ethical considerations The study was approved by the Biosafety committee, research ethics&#xD;
        committee and research committee of the University Center for Health Sciences, University of&#xD;
        Guadalajara: CI-00421. The committees of the University have the authority to monitor and&#xD;
        audit the study at any of its stages once it has been approved.&#xD;
  &#xD;
        Objetives General objective Evaluate the effect of vitamin K2 supplementation on methylation,&#xD;
        the serum concentration of total vitamin K, osteocalcin, growth arrest-specific 6 protein,&#xD;
        leptin, inflammatory markers, cardiometabolic risk factors and cardiovascular risk in young&#xD;
        Mexican adults with overweight or obesity.&#xD;
  &#xD;
        Specific objectives&#xD;
  &#xD;
          1. Compare the baseline variables between groups.&#xD;
  &#xD;
          2. Compare the variable changes across the time within groups&#xD;
  &#xD;
          3. Compare the variable changes across the time between groups&#xD;
  &#xD;
        Statistical analysis The Shapiro-Wilk normality test is performed to determine whether the&#xD;
        analysis will require parametric or non-parametric tests. Qualitative variables will be&#xD;
        expressed as frequencies and percentages, while quantitative variables will be expressed as&#xD;
        mean and standard deviation in parametric data or medians and ranges in non-parametric data.&#xD;
  &#xD;
        Specific objective 1 Statistical technique T-student for independent samples if it has a&#xD;
        normal distribution or by U-Mann Whitney for independent samples if it does not have a normal&#xD;
        distribution&#xD;
  &#xD;
        Specific objective 2 Variables with two measures Statistical technique T-student for paired&#xD;
        samples if it has a normal distribution or the Wilcoxon signed-rank test if it does not have&#xD;
        a normal distribution&#xD;
  &#xD;
        Variables with more than two measures Statistical technique Repeated measures ANOVA if it has&#xD;
        a normal distribution or the Friedman Test if it does not have a normal distribution&#xD;
  &#xD;
        Specific objective 3 Statistical technique The effect size of the groups is compared with&#xD;
        T-student for independent samples if it has a normal distribution or by U-Mann Whitney for&#xD;
        independent samples if it does not have a normal distribution&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</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>
      <intervention_model_description>Clinical trial parallel design. Two groups with intervention, one with supplementation and other with placebo</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>All participants were given an identical vial, with an invention similar in shape, color, and consistency.&#xD;
  The groups were named group A and group B.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Osteocalcin serum concentration</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>ng/dL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Vitamin K serum concentration</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>ng/dL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Leptin serum concentration</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>ng/dL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tumour Necrosis Factor alpha serum concentration</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>pg/mL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Interleukin-1 Beta serum concentration</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>pg/mL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Interleukin-6 serum concentration</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>pg/mL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Interleukin-4 serum concentration</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>pg/mL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Interleukin-10 serum concentration</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>pg/mL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cardiovascular risk</measure>
      <time_frame>Baseline, after 30, 60 and 90 days of intervention</time_frame>
      <description>percentage</description>
    </primary_outcome>
    <primary_outcome>
      <measure>LEP gene methylation</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>Methylated or unmethylated</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Growth arrest-specific 6 protein serum concentration</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>ng/ml</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Global methylation</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>percentage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Atherogenic indices</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>Value</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Triglycerides serum concentration</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>mg/dL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total cholesterol serum concentration</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>mg/dL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HDL cholesterol serum concentration</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>mg/dL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LDL cholesterol serum concentration</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>mg/dL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VLDL cholesterol serum concentration</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>mg/dL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Glucose serum concentration</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>mg/dL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>Baseline, after 30, 60 and 90 days of intervention</time_frame>
      <description>mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin serum concentration</measure>
      <time_frame>Baseline and after 90 days of intervention</time_frame>
      <description>µIU/ml</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>Baseline, after 30, 60 and 90 days of intervention</time_frame>
      <description>kg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body mass index</measure>
      <time_frame>Baseline, after 30, 60 and 90 days of intervention</time_frame>
      <description>kg/m2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Waist circumference</measure>
      <time_frame>Baseline, after 30, 60 and 90 days of intervention</time_frame>
      <description>cm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hip circumference</measure>
      <time_frame>Baseline, after 30, 60 and 90 days of intervention</time_frame>
      <description>cm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fat mass</measure>
      <time_frame>Baseline, after 30, 60 and 90 days of intervention</time_frame>
      <description>kg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>% fat</measure>
      <time_frame>Baseline, after 30, 60 and 90 days of intervention</time_frame>
      <description>percentage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lean mass</measure>
      <time_frame>Baseline, after 30, 60 and 90 days of intervention</time_frame>
      <description>kg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimated energy consumption</measure>
      <time_frame>Baseline, after 30, 60 and 90 days of intervention</time_frame>
      <description>kcal/day</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimated protein consumption</measure>
      <time_frame>Baseline, after 30, 60 and 90 days of intervention</time_frame>
      <description>grams/day</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimated carbohydrates consumption</measure>
      <time_frame>Baseline, after 30, 60 and 90 days of intervention</time_frame>
      <description>grams/day</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimated fat consumption</measure>
      <time_frame>Baseline, after 30, 60 and 90 days of intervention</time_frame>
      <description>grams/day</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimated vitamin K consumption</measure>
      <time_frame>Baseline, after 30, 60 and 90 days of intervention</time_frame>
      <description>μg/day</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">51</enrollment>
    <condition>Overweight and Obesity</condition>
    <condition>Cardiometabolic Risk Factors</condition>
    <arm_group>
      <arm_group_label>Supplementation arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Vitamin K2</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo arm</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Cornstarch</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Vitamin K2</intervention_name>
      <description>100 µg per day for 90 days</description>
      <arm_group_label>Supplementation arm</arm_group_label>
      <other_name>Nutricost Menaquinone-4 100 µg</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cornstarch</intervention_name>
      <description>500 mg per day for 90 days</description>
      <arm_group_label>Placebo arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Body Mass Index greater than 25 kg/m2 and less than 40 kg/m2&#xD;
  &#xD;
            -  That they agree to participate in the study voluntarily and informed and sign the&#xD;
               informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  People with self-reported diagnosis of chronic kidney, gastrointestinal or systemic&#xD;
               disease&#xD;
  &#xD;
            -  Use of bile acid sequestrants drugs, insulin, glucocorticoids, contraceptives,&#xD;
               bisphosphonates, thiazides, levetiracetam, thiazolidinediones, anticoagulants or&#xD;
               estrogenic drugs and vitamin D, vitamin K, vitamin A, vitamin E, omegas or calcium&#xD;
               supplements&#xD;
  &#xD;
            -  Patients who are on a hypocaloric or low-fat diet&#xD;
  &#xD;
            -  Self-reported pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Andrés López Quintero, PhD</last_name>
      <role>Principal Investigator</role>
    </overall_official>
    <overall_contact>
      <last_name>Andrés López Quintero, PhD</last_name>
      <phone>33 1058 5200</phone>
      <phone_ext>34294</phone_ext>
      <email>andres.lopezq@academicos.udg.mx</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Edgar A Rivera León, PhD</last_name>
      <phone>(378) 782 8033</phone>
      <phone_ext>56928</phone_ext>
      <email>edgar.rleon@academicos.udg.mx</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Guadalajara</name>
        <address>
          <city>Guadalajara</city>
          <state>Jalisco</state>
          <zip>44340</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <contact>
        <last_name>Andrés López Quintero, PhD</last_name>
        <phone>33 1058 5200</phone>
        <phone_ext>34294</phone_ext>
        <email>andres.lopezq@academicos.udg.mx</email>
      </contact>
      <contact_backup>
        <last_name>Edgar A Rivera León, PhD</last_name>
        <phone>(378) 782 8033</phone>
        <phone_ext>56928</phone_ext>
        <email>edgar.rleon@academicos.udg.mx</email>
      </contact_backup>
      <investigator>
        <last_name>Andrés López Quintero, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Mexico</country>
    </location_countries>
    <reference>
      <citation>Aguayo-Ruiz JI, Garcia-Cobian TA, Pascoe-Gonzalez S, Sanchez-Enriquez S, Llamas-Covarrubias IM, Garcia-Iglesias T, Lopez-Quintero A, Llamas-Covarrubias MA, Trujillo-Quiroz J, Rivera-Leon EA. Effect of supplementation with vitamins D3 and K2 on undercarboxylated osteocalcin and insulin serum levels in patients with type 2 diabetes mellitus: a randomized, double-blind, clinical trial. Diabetol Metab Syndr. 2020 Aug 18;12:73. doi: 10.1186/s13098-020-00580-w. eCollection 2020.</citation>
      <PMID>32831908</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Guadalajara</investigator_affiliation>
      <investigator_full_name>Andrés López Quintero</investigator_full_name>
      <investigator_title>Associate Professor B</investigator_title>
    </responsible_party>
    <keyword>Vitamin K</keyword>
    <keyword>Overweight and Obesity</keyword>
    <keyword>Cardiometabolic Risk Factors</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</mesh_term>
      <mesh_term>Overweight</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vitamin K</mesh_term>
      <mesh_term>Vitamin K 2</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05995522
  org study id: CI-00421
  nct id: NCT05995522
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare de effect of vitamin K2 in young adults with
        overweight or obesity. The main questions to answer are:
  
        What is the effect of Vitamin K2 supplementation on methylation, serum concentration of ucOC,
        cOC, Gas6, leptin, inflammatory markers, cardiometabolic risk factors, and cardiovascular
        risk in overweight or obese young adults? Participants will be assigned to one of two
        intervention groups where they will consume Vitamin K2 100 µg per day or cornstarch 500 mg
        per day for 90 days.
  
        If there is a comparison group: Investigators will compare the supplementation group (Vitamin
        K2) with the placebo group (cornstarch) to see if vitamin K2 supplementation modifies
        methylation, increases serum vitamin K, osteocalcin, growth arrest-specific 6 protein serum
        concentration, decreases serum leptin concentration, inflammatory markers and reduces
        cardiometabolic risk factors and cardiovascular risk.
  Study Overview To meet the objectives of the project, two groups will be compared, one that
        will be supplemented with vitamin K and another of patients who will receive corn starch as a
        placebo. Patients are going to have a follow up during 3 months with periodic evaluations
        every 30 days.
  
        This is a double-blind study, it is achieved by maintaining similarities in appearance, taste
        and smell between the treatments that will be delivered in the same vials, with same number
        of pills and identical in shape, color and consistency for each study group.
  
        Patient recruitment will take place by disseminating information through physical and social
        media, once potential participants have been identified, they will be contacted and informed
        about the project, and if they decide to participate in the study, they will be asked to sign
        the informed consent.
  
        Simple randomization will be performed using R software to assign participants to one of the
        study groups. A clinical history, anthropometric measurements and blood sampling shall be
        applied.
  
        Nutritional recommendations based on the position of the Academy of Nutrition and Dietetics
        for the treatment of overweight and obesity and the healthy eating plate of Harvard
        University will be given. An appointment is to be scheduled every 30 days in order to provide
        the supplementation and follow-up. At the end, the pertinent statistical analyzes will be
        carried out.
  
        Notification of adverse effects will be made in each of the sessions, in addition to this the
        participants will have the contact of the researchers to notify any anomaly.
  
        Sample's size calculation
  
        The sample size was calculated using the statistical formula for the comparison of two means.
        This estimate was made using the following formula:
  
        n=2(Zα+Z[1-β]2xSD2/d2
  
        Where:
  
        n= sample size required in each group SD= standard deviation of the effect Zα: to the value
        of Z for a confidence level of 95% Z[1-β}: to the value of Z for a statistical power of 80%
        D= effect size A total of 19.72 patients per group were obtained. Considering a 20% loss, 24
        patients are needed per study group.
  
        Ethical considerations The study was approved by the Biosafety committee, research ethics
        committee and research committee of the University Center for Health Sciences, University of
        Guadalajara: CI-00421. The committees of the University have the authority to monitor and
        audit the study at any of its stages once it has been approved.
  
        Objetives General objective Evaluate the effect of vitamin K2 supplementation on methylation,
        the serum concentration of total vitamin K, osteocalcin, growth arrest-specific 6 protein,
        leptin, inflammatory markers, cardiometabolic risk factors and cardiovascular risk in young
        Mexican adults with overweight or obesity.
  
        Specific objectives
  
          1. Compare the baseline variables between groups.
  
          2. Compare the variable changes across the time within groups
  
          3. Compare the variable changes across the time between groups
  
        Statistical analysis The Shapiro-Wilk normality test is performed to determine whether the
        analysis will require parametric or non-parametric tests. Qualitative variables will be
        expressed as frequencies and percentages, while quantitative variables will be expressed as
        mean and standard deviation in parametric data or medians and ranges in non-parametric data.
  
        Specific objective 1 Statistical technique T-student for independent samples if it has a
        normal distribution or by U-Mann Whitney for independent samples if it does not have a normal
        distribution
  
        Specific objective 2 Variables with two measures Statistical technique T-student for paired
        samples if it has a normal distribution or the Wilcoxon signed-rank test if it does not have
        a normal distribution
  
        Variables with more than two measures Statistical technique Repeated measures ANOVA if it has
        a normal distribution or the Friedman Test if it does not have a normal distribution
  
        Specific objective 3 Statistical technique The effect size of the groups is compared with
        T-student for independent samples if it has a normal distribution or by U-Mann Whitney for
        independent samples if it does not have a normal distribution
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Clinical trial parallel design. Two groups with intervention, one with supplementation and other with placebo
  primary purpose: Prevention
  masking: Double (Participant, Investigator)
  masking description: All participants were given an identical vial, with an invention similar in shape, color, and consistency.
  The groups were named group A and group B.
  measure: Osteocalcin serum concentration
  time frame: Baseline and after 90 days of intervention
  description: ng/dL
  measure: Vitamin K serum concentration
  time frame: Baseline and after 90 days of intervention
  description: ng/dL
  measure: Leptin serum concentration
  time frame: Baseline and after 90 days of intervention
  description: ng/dL
  measure: Tumour Necrosis Factor alpha serum concentration
  time frame: Baseline and after 90 days of intervention
  description: pg/mL
  measure: Interleukin-1 Beta serum concentration
  time frame: Baseline and after 90 days of intervention
  description: pg/mL
  measure: Interleukin-6 serum concentration
  time frame: Baseline and after 90 days of intervention
  description: pg/mL
  measure: Interleukin-4 serum concentration
  time frame: Baseline and after 90 days of intervention
  description: pg/mL
  measure: Interleukin-10 serum concentration
  time frame: Baseline and after 90 days of intervention
  description: pg/mL
  measure: Cardiovascular risk
  time frame: Baseline, after 30, 60 and 90 days of intervention
  description: percentage
  measure: LEP gene methylation
  time frame: Baseline and after 90 days of intervention
  description: Methylated or unmethylated
  measure: Growth arrest-specific 6 protein serum concentration
  time frame: Baseline and after 90 days of intervention
  description: ng/ml
  measure: Global methylation
  time frame: Baseline and after 90 days of intervention
  description: percentage
  measure: Atherogenic indices
  time frame: Baseline and after 90 days of intervention
  description: Value
  measure: Triglycerides serum concentration
  time frame: Baseline and after 90 days of intervention
  description: mg/dL
  measure: Total cholesterol serum concentration
  time frame: Baseline and after 90 days of intervention
  description: mg/dL
  measure: HDL cholesterol serum concentration
  time frame: Baseline and after 90 days of intervention
  description: mg/dL
  measure: LDL cholesterol serum concentration
  time frame: Baseline and after 90 days of intervention
  description: mg/dL
  measure: VLDL cholesterol serum concentration
  time frame: Baseline and after 90 days of intervention
  description: mg/dL
  measure: Glucose serum concentration
  time frame: Baseline and after 90 days of intervention
  description: mg/dL
  measure: Blood pressure
  time frame: Baseline, after 30, 60 and 90 days of intervention
  description: mmHg
  measure: Insulin serum concentration
  time frame: Baseline and after 90 days of intervention
  description: µIU/ml
  measure: Weight
  time frame: Baseline, after 30, 60 and 90 days of intervention
  description: kg
  measure: Body mass index
  time frame: Baseline, after 30, 60 and 90 days of intervention
  description: kg/m2
  measure: Waist circumference
  time frame: Baseline, after 30, 60 and 90 days of intervention
  description: cm
  measure: Hip circumference
  time frame: Baseline, after 30, 60 and 90 days of intervention
  description: cm
  measure: Fat mass
  time frame: Baseline, after 30, 60 and 90 days of intervention
  description: kg
  measure: % fat
  time frame: Baseline, after 30, 60 and 90 days of intervention
  description: percentage
  measure: Lean mass
  time frame: Baseline, after 30, 60 and 90 days of intervention
  description: kg
  measure: Estimated energy consumption
  time frame: Baseline, after 30, 60 and 90 days of intervention
  description: kcal/day
  measure: Estimated protein consumption
  time frame: Baseline, after 30, 60 and 90 days of intervention
  description: grams/day
  measure: Estimated carbohydrates consumption
  time frame: Baseline, after 30, 60 and 90 days of intervention
  description: grams/day
  measure: Estimated fat consumption
  time frame: Baseline, after 30, 60 and 90 days of intervention
  description: grams/day
  measure: Estimated vitamin K consumption
  time frame: Baseline, after 30, 60 and 90 days of intervention
  description: μg/day
  arm group label: Supplementation arm
  arm group type: Experimental
  description: Vitamin K2
  arm group label: Placebo arm
  arm group type: Placebo Comparator
  description: Cornstarch
  intervention type: Dietary Supplement
  intervention name: Vitamin K2
  description: 100 µg per day for 90 days
  arm group label: Supplementation arm
  other name: Nutricost Menaquinone-4 100 µg
  intervention type: Other
  intervention name: Cornstarch
  description: 500 mg per day for 90 days
  arm group label: Placebo arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: No
  last name: Andrés López Quintero, PhD
  role: Principal Investigator
  last name: Andrés López Quintero, PhD
  phone: 33 1058 5200
  phone ext: 34294
  email: andres.lopezq@academicos.udg.mx
  last name: Edgar A Rivera León, PhD
  phone: (378) 782 8033
  phone ext: 56928
  email: edgar.rleon@academicos.udg.mx
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: Mexico
  citation: Aguayo-Ruiz JI, Garcia-Cobian TA, Pascoe-Gonzalez S, Sanchez-Enriquez S, Llamas-Covarrubias IM, Garcia-Iglesias T, Lopez-Quintero A, Llamas-Covarrubias MA, Trujillo-Quiroz J, Rivera-Leon EA. Effect of supplementation with vitamins D3 and K2 on undercarboxylated osteocalcin and insulin serum levels in patients with type 2 diabetes mellitus: a randomized, double-blind, clinical trial. Diabetol Metab Syndr. 2020 Aug 18;12:73. doi: 10.1186/s13098-020-00580-w. eCollection 2020.
  PMID: 32831908
  responsible party type: Principal Investigator
  investigator affiliation: University of Guadalajara
  investigator full name: Andrés López Quintero
  investigator title: Associate Professor B
  mesh term: Obesity
  mesh term: Overweight
  mesh term: Vitamin K
  mesh term: Vitamin K 2
  sharing ipd: No