<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/NCT04488731</url>
  </required_header>
  <id_info>
    <org_study_id>2020-PHA-19</org_study_id>
    <nct_id>NCT04488731</nct_id>
  </id_info>
  <brief_title>The Effect of Coffee Consumption on the Serum Levels of Leptin, Folic Acid, and Vitamin B12</brief_title>
  <official_title>The Effect of Coffee Consumption and Body Weight on the Serum Levels of Leptin, Folic Acid, and Vitamin B12 in Young Males: A Cross-Sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Applied Science Private University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Applied Science Private University</source>
  <oversight_info>
    <has_dmc>Yes</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 effect of coffee and body weight during the last 3 months on the level of leptin, folic&#xD;
      acid, and vitamin B12&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coffee consumption has been associated with several risk factors leading to cardiovascular&#xD;
      diseases (CVDs), including hyperhomocysteinemia and hyperlipidemia. Frequent coffee&#xD;
      consumption has beneficial effects in reducing the risk of diabetes mellitus (DM) type 2,&#xD;
      obesity, liver disease, CVDs, some types of cancer, Parkinson's disease, and Alzheimer's&#xD;
      disease. Controversies concerning coffee consumption benefits and risks in regards for CVDs&#xD;
      were mentioned in many studies. Folic acid and vitamin B12 are necessary vitamins in&#xD;
      homocysteine metabolism which is a risk factor for atherosclerosis. Leptin, is a hormone&#xD;
      linked to obesity and it could be related to atherosclerosis.&#xD;
&#xD;
      The combined effect of coffee consumption and body weight on the levels of leptin, folic aid,&#xD;
      and vitamin B12 is not well studied. In our study, we will study the effect of coffee&#xD;
      consumption in males with different body mass indices to see the effect of several important&#xD;
      parameters such as leptin, Folic acid, and vitamin B12.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">July 26, 2020</start_date>
  <completion_date type="Anticipated">October 26, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 26, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>leptin</measure>
    <time_frame>Baseline</time_frame>
    <description>Plasma Concentration of leptin in ng /ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>folic acid</measure>
    <time_frame>Baseline</time_frame>
    <description>Plasma Concentration of folic acid in ng /ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vitamin B12</measure>
    <time_frame>Baseline</time_frame>
    <description>Plasma Concentration of Vitamin B12 in pg /ml</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>fasting blood glucose</measure>
    <time_frame>Baseline</time_frame>
    <description>Plasma Concentration of glucose mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lipid profile</measure>
    <time_frame>Baseline</time_frame>
    <description>Plasma Concentration of LDL, HDL in mg/dl</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>NW/MCC</arm_group_label>
    <description>Normal body mass index (BMI) / with moderate coffee consumption</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NW/HCC</arm_group_label>
    <description>Normal body mass index (BMI) / with heavy coffee consumption</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OW/MCC</arm_group_label>
    <description>Overweight / with moderate coffee consumption</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OW/HCC</arm_group_label>
    <description>Overweight / with heavy coffee consumption</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Normal BMI and moderate coffee consumption</intervention_name>
    <description>Normal BMI and moderate coffee consumption</description>
    <arm_group_label>NW/MCC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Normal BMI and heavy coffee consumption</intervention_name>
    <description>Normal BMI and heavy coffee consumption</description>
    <arm_group_label>NW/HCC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>overweight and moderate coffee consumption</intervention_name>
    <description>overweight and moderate coffee consumption</description>
    <arm_group_label>OW/MCC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>overweight and heavy coffee consumption</intervention_name>
    <description>overweight and heavy coffee consumption</description>
    <arm_group_label>OW/HCC</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum samples will be retained&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Young male students studying at Applied Science Private University (ASU) in Amman were&#xD;
        approached for study participation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male,&#xD;
&#xD;
          -  ASU student,&#xD;
&#xD;
          -  do not have any acute or chronic medical conditions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  students who used any medications for either an acute and/or a chronic condition&#xD;
             during the past 3 months prior to the study entry.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only young males are considered</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud S Abu-samak, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Applied Sciences Private University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Applied Science University</name>
      <address>
        <city>Amman</city>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <results_reference>
    <citation>Grubben MJ, Boers GH, Blom HJ, Broekhuizen R, de Jong R, van Rijt L, de Ruijter E, Swinkels DW, Nagengast FM, Katan MB. Unfiltered coffee increases plasma homocysteine concentrations in healthy volunteers: a randomized trial. Am J Clin Nutr. 2000 Feb;71(2):480-4. doi: 10.1093/ajcn/71.2.480.</citation>
    <PMID>10648261</PMID>
  </results_reference>
  <results_reference>
    <citation>Ma Y, Peng D, Liu C, Huang C, Luo J. Serum high concentrations of homocysteine and low levels of folic acid and vitamin B12 are significantly correlated with the categories of coronary artery diseases. BMC Cardiovasc Disord. 2017 Jan 21;17(1):37. doi: 10.1186/s12872-017-0475-8.</citation>
    <PMID>28109191</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>August 13, 2020</last_update_submitted>
  <last_update_submitted_qc>August 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coffee</keyword>
  <keyword>BMI</keyword>
  <keyword>Leptin</keyword>
  <keyword>Folic acid</keyword>
  <keyword>Vitamin B12</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All IPD that underline results in a publication.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>When summary data are published</ipd_time_frame>
    <ipd_access_criteria>Open access</ipd_access_criteria>
  </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/NCT04488731
org study id: 2020-PHA-19
nct id: NCT04488731
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The effect of coffee and body weight during the last 3 months on the level of leptin, folic
      acid, and vitamin B12
Coffee consumption has been associated with several risk factors leading to cardiovascular
      diseases (CVDs), including hyperhomocysteinemia and hyperlipidemia. Frequent coffee
      consumption has beneficial effects in reducing the risk of diabetes mellitus (DM) type 2,
      obesity, liver disease, CVDs, some types of cancer, Parkinson's disease, and Alzheimer's
      disease. Controversies concerning coffee consumption benefits and risks in regards for CVDs
      were mentioned in many studies. Folic acid and vitamin B12 are necessary vitamins in
      homocysteine metabolism which is a risk factor for atherosclerosis. Leptin, is a hormone
      linked to obesity and it could be related to atherosclerosis.

      The combined effect of coffee consumption and body weight on the levels of leptin, folic aid,
      and vitamin B12 is not well studied. In our study, we will study the effect of coffee
      consumption in males with different body mass indices to see the effect of several important
      parameters such as leptin, Folic acid, and vitamin B12.
observational model: Other
time perspective: Cross-Sectional
measure: leptin
time frame: Baseline
description: Plasma Concentration of leptin in ng /ml
measure: folic acid
time frame: Baseline
description: Plasma Concentration of folic acid in ng /ml
measure: Vitamin B12
time frame: Baseline
description: Plasma Concentration of Vitamin B12 in pg /ml
measure: fasting blood glucose
time frame: Baseline
description: Plasma Concentration of glucose mg/dL
measure: lipid profile
time frame: Baseline
description: Plasma Concentration of LDL, HDL in mg/dl
arm group label: NW/MCC
description: Normal body mass index (BMI) / with moderate coffee consumption
arm group label: NW/HCC
description: Normal body mass index (BMI) / with heavy coffee consumption
arm group label: OW/MCC
description: Overweight / with moderate coffee consumption
arm group label: OW/HCC
description: Overweight / with heavy coffee consumption
intervention type: Behavioral
intervention name: Normal BMI and moderate coffee consumption
description: Normal BMI and moderate coffee consumption
arm group label: NW/MCC
intervention type: Behavioral
intervention name: Normal BMI and heavy coffee consumption
description: Normal BMI and heavy coffee consumption
arm group label: NW/HCC
intervention type: Behavioral
intervention name: overweight and moderate coffee consumption
description: overweight and moderate coffee consumption
arm group label: OW/MCC
intervention type: Behavioral
intervention name: overweight and heavy coffee consumption
description: overweight and heavy coffee consumption
arm group label: OW/HCC
Serum samples will be retained
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
gender based: Yes
gender description: Only young males are considered
minimum age: 18 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mahmoud S Abu-samak, PhD
role: Principal Investigator
affiliation: Applied Sciences Private University
facility: 
country: Jordan
citation: Grubben MJ, Boers GH, Blom HJ, Broekhuizen R, de Jong R, van Rijt L, de Ruijter E, Swinkels DW, Nagengast FM, Katan MB. Unfiltered coffee increases plasma homocysteine concentrations in healthy volunteers: a randomized trial. Am J Clin Nutr. 2000 Feb;71(2):480-4. doi: 10.1093/ajcn/71.2.480.
PMID: 10648261
citation: Ma Y, Peng D, Liu C, Huang C, Luo J. Serum high concentrations of homocysteine and low levels of folic acid and vitamin B12 are significantly correlated with the categories of coronary artery diseases. BMC Cardiovasc Disord. 2017 Jan 21;17(1):37. doi: 10.1186/s12872-017-0475-8.
PMID: 28109191
responsible party type: Sponsor
mesh term: Atherosclerosis
sharing ipd: Yes
ipd description: All IPD that underline results in a publication.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: When summary data are published
ipd access criteria: Open access