<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/NCT02253628</url>
  </required_header>
  <id_info>
    <org_study_id>340302</org_study_id>
    <nct_id>NCT02253628</nct_id>
  </id_info>
  <brief_title>The Acute Effect of Coffee Consumption on Stomach, Self-reported Gastrointestinal Symptoms and Stress.</brief_title>
  <official_title>The Acute Effect of Coffee Consumption on Salivary Gastrin, Alpha-amylase and Cortisol Concentrations, on Self-reported Gastrointestinal Symptoms, on Self-reported Psychometric Assessments and on Blood Pressure.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Agricultural University of Athens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Agricultural University of Athens</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigated the acute effect of the consumption of four different kinds of coffee&#xD;
      (hot and cold instant coffee, cold espresso and hot filter coffee) with the same caffeine&#xD;
      content on salivary gastrin, cortisol and alpha-amylase concentrations, on self-reported&#xD;
      gastrointestinal symptoms and on psychometric assessments in healthy individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coffee consumption is very common in Greece. Many of the consumers support that certain types&#xD;
      of coffee and especially instant coffee cause gastrointestinal symptoms in healthy&#xD;
      individuals. Up to now, few studies have investigated the relationship between coffee&#xD;
      consumption, gastrointestinal symptoms and stress in healthy individuals with conflicting&#xD;
      results.Coffee consumption is related with increased gastric acid and gastrin secretion,&#xD;
      however it does not seem to affect stomach or stomach walls. Stress, which characterizes&#xD;
      modern lifestyle, also is found to increase gastric acid and gastrin secretion and seems to&#xD;
      be exclusively responsible for gastrointestinal symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Salivary gastrin and self-reported gastrointestinal symptoms</measure>
    <time_frame>4 weeks</time_frame>
    <description>The volunteers visited the lab after an 8-hour fasting. Saliva samples were taken at fasting for the determination of fasting salivary gastrin. After the consumption of coffee, saliva samples were taken at 15, 30, 60' for the determination of gastrin. Saliva samples were collected by the method &quot;Salivette&quot;. Saliva was carried out by chewing a swab for about 1 minute. Then, the swab was returned to the Salivette and the container was centrifuged and saliva sample was obtained. The samples were stored at - 20 degrees of Celsius. Gastrin was determined by an immunoenzymatic method. In order to record the effects of coffee consumption on gastrointestinal symptoms, the participants completed a visual analogue scale every time saliva samples were collected (time 0', 15', 30', 60', 120', 180'). The visual analogue scale (1 = not at all to 10 = very) included 12 questions about gastrointestinal symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure, energy intake and physical activity</measure>
    <time_frame>4 weeks</time_frame>
    <description>The aim was to investigate if blood pressure, energy intake and physical activity changed during the intervention. Blood pressure was measured three times in a sitting position after 15 minutes of rest by a mercury sphygmomanometer at the beginning and ending of each trial respectively. There was a 2-minute interval between measurements. Then, the average blood pressure measurements were calculated. Dietary intake was analyzed by Diet Analysis Plus (version 6.1). The database was extensively modified to include new foods and recipes. Physical activity was estimated by using metabolic equivalents of different activities performed by the volunteers the previous 7 days. Then, mean daily energy expenditure was estimated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary cortisol and alpha-amylase</measure>
    <time_frame>4 weeks</time_frame>
    <description>The volunteers visited the lab after an 8-hour fasting. Saliva samples were taken at fasting for the determination of fasting salivary cortisol and alpha-amylase. After the consumption of coffee, saliva samples were taken at 15, 30, 60' for the determination of alpha-amylase and at 60, 120, 180' for cortisol determination.Saliva samples were collected by the method &quot;Salivette&quot;. Saliva was carried out by chewing a swab for about 1 minute. Then, the swab was returned to the Salivette and the container was centrifuged and saliva sample was obtained. The samples were stored at - 20 degrees of Celsius. Cortisol was determined by an immunoenzymatic method. Alpha-amylase was determined by a kinetic enzyme assay kit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported sentiments, mood and stress.</measure>
    <time_frame>4 weeks</time_frame>
    <description>In order to record the effects of coffee consumption on stress and on sentiments and mood the participants completed the Zung self-assessment anxiety scale and a visual analogue scale every time saliva samples were collected (time 0', 15', 30', 60', 120', 180'). The Zung self-assessment anxiety scale included 20 questions, which were designed to assess how the volunteers felt the moment completing the questionnaire. The visual analogue scale (1 = not at all to 10 = very) included 17 questions about stress, sentiments and mood.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Stress</condition>
  <condition>Signs and Symptoms, Digestive</condition>
  <condition>Blood Pressure</condition>
  <condition>Increased Secretion of Gastrin</condition>
  <arm_group>
    <arm_group_label>Trial 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Forty healthy men and women, with normal body weight. Volunteers consumed randomly 4 coffee beverages with 160 mg caffeine (hot instant coffee, cold instant coffee, cold espresso, hot filter coffee).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trial 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Forty healthy men and women, with normal body weight. Volunteers consumed randomly 4 coffee beverages with 160 mg caffeine (hot instant coffee, cold instant coffee, cold espresso, hot filter coffee).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trial 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Forty healthy men and women, with normal body weight. Volunteers consumed randomly 4 coffee beverages with 160 mg caffeine (hot instant coffee, cold instant coffee, cold espresso, hot filter coffee).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trial 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Forty healthy men and women, with normal body weight. Volunteers consumed randomly 4 coffee beverages with 160 mg caffeine (hot instant coffee, cold instant coffee, cold espresso, hot filter coffee).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cold espresso</intervention_name>
    <description>Volunteers consumed cold espresso with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.</description>
    <arm_group_label>Trial 1</arm_group_label>
    <arm_group_label>Trial 2</arm_group_label>
    <arm_group_label>Trial 3</arm_group_label>
    <arm_group_label>Trial 4</arm_group_label>
    <other_name>Buondi prestige</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hot instant coffee</intervention_name>
    <description>Volunteers consumed hot instant coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.</description>
    <arm_group_label>Trial 1</arm_group_label>
    <arm_group_label>Trial 2</arm_group_label>
    <arm_group_label>Trial 3</arm_group_label>
    <arm_group_label>Trial 4</arm_group_label>
    <other_name>Nescafé Classic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cold instant coffee</intervention_name>
    <description>Volunteers consumed cold instant coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.</description>
    <arm_group_label>Trial 1</arm_group_label>
    <arm_group_label>Trial 2</arm_group_label>
    <arm_group_label>Trial 3</arm_group_label>
    <arm_group_label>Trial 4</arm_group_label>
    <other_name>Nescafé Classic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hot filter coffee</intervention_name>
    <description>Volunteers consumed hot filter coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.</description>
    <arm_group_label>Trial 1</arm_group_label>
    <arm_group_label>Trial 2</arm_group_label>
    <arm_group_label>Trial 3</arm_group_label>
    <arm_group_label>Trial 4</arm_group_label>
    <other_name>Nestlé Professional Plantage Filter Coffee</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stable body weight for at least 1 month prior to study enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If one volunteer consumed breakfast more than three days a week, their daily caffeine&#xD;
             intake was over 500 mg caffeine, was taking medication, their psychological state was&#xD;
             strongly influenced by some exogenous factor (e.g. moving to a new house, new job,&#xD;
             divorce e.t.c.), was on hypocaloric diet for weight loss, was smoking more than five&#xD;
             cigarettes a day, was an athlete with very vigorous physical activity (&gt; 4 hours&#xD;
             vigorous exercise a day), had a history of gastrointestinal disorders (e.g.&#xD;
             gastroesophageal reflux disease (GERD), irritable bowel syndrome, diarrhea, ulcers&#xD;
             e.t.c.), depression, diabetes, kidney disease, hypertension, blood disorders, liver&#xD;
             disease, unregulated hyper - or hypothyroidism, arrhythmia, heart disease, cancer,&#xD;
             vascular disease, recent surgery, or severe psychiatric disorders was automatically&#xD;
             excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aimilia Papakonstantinou, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Agricultural University of Athens</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Agricultural University of Athens</investigator_affiliation>
    <investigator_full_name>Aimilia Papakonstantinou</investigator_full_name>
    <investigator_title>Lecturer of Nutrition and Metabolism</investigator_title>
  </responsible_party>
  <keyword>Coffee</keyword>
  <keyword>Gastrin</keyword>
  <keyword>Alpha-amylase</keyword>
  <keyword>Cortisol</keyword>
  <keyword>Self-reported gastrointestinal symptoms</keyword>
  <keyword>Self-reported stress</keyword>
  <keyword>Blood pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Signs and Symptoms, Digestive</mesh_term>
  </condition_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/NCT02253628
org study id: 340302
nct id: NCT02253628
lead sponsor: 
collaborator: 
has dmc: No
This study investigated the acute effect of the consumption of four different kinds of coffee
      (hot and cold instant coffee, cold espresso and hot filter coffee) with the same caffeine
      content on salivary gastrin, cortisol and alpha-amylase concentrations, on self-reported
      gastrointestinal symptoms and on psychometric assessments in healthy individuals.
Coffee consumption is very common in Greece. Many of the consumers support that certain types
      of coffee and especially instant coffee cause gastrointestinal symptoms in healthy
      individuals. Up to now, few studies have investigated the relationship between coffee
      consumption, gastrointestinal symptoms and stress in healthy individuals with conflicting
      results.Coffee consumption is related with increased gastric acid and gastrin secretion,
      however it does not seem to affect stomach or stomach walls. Stress, which characterizes
      modern lifestyle, also is found to increase gastric acid and gastrin secretion and seems to
      be exclusively responsible for gastrointestinal symptoms.
allocation: Randomized
intervention model: Crossover Assignment
masking: Single (Participant)
measure: Salivary gastrin and self-reported gastrointestinal symptoms
time frame: 4 weeks
description: The volunteers visited the lab after an 8-hour fasting. Saliva samples were taken at fasting for the determination of fasting salivary gastrin. After the consumption of coffee, saliva samples were taken at 15, 30, 60' for the determination of gastrin. Saliva samples were collected by the method "Salivette". Saliva was carried out by chewing a swab for about 1 minute. Then, the swab was returned to the Salivette and the container was centrifuged and saliva sample was obtained. The samples were stored at - 20 degrees of Celsius. Gastrin was determined by an immunoenzymatic method. In order to record the effects of coffee consumption on gastrointestinal symptoms, the participants completed a visual analogue scale every time saliva samples were collected (time 0', 15', 30', 60', 120', 180'). The visual analogue scale (1 = not at all to 10 = very) included 12 questions about gastrointestinal symptoms.
measure: Blood pressure, energy intake and physical activity
time frame: 4 weeks
description: The aim was to investigate if blood pressure, energy intake and physical activity changed during the intervention. Blood pressure was measured three times in a sitting position after 15 minutes of rest by a mercury sphygmomanometer at the beginning and ending of each trial respectively. There was a 2-minute interval between measurements. Then, the average blood pressure measurements were calculated. Dietary intake was analyzed by Diet Analysis Plus (version 6.1). The database was extensively modified to include new foods and recipes. Physical activity was estimated by using metabolic equivalents of different activities performed by the volunteers the previous 7 days. Then, mean daily energy expenditure was estimated.
measure: Salivary cortisol and alpha-amylase
time frame: 4 weeks
description: The volunteers visited the lab after an 8-hour fasting. Saliva samples were taken at fasting for the determination of fasting salivary cortisol and alpha-amylase. After the consumption of coffee, saliva samples were taken at 15, 30, 60' for the determination of alpha-amylase and at 60, 120, 180' for cortisol determination.Saliva samples were collected by the method "Salivette". Saliva was carried out by chewing a swab for about 1 minute. Then, the swab was returned to the Salivette and the container was centrifuged and saliva sample was obtained. The samples were stored at - 20 degrees of Celsius. Cortisol was determined by an immunoenzymatic method. Alpha-amylase was determined by a kinetic enzyme assay kit.
measure: Self-reported sentiments, mood and stress.
time frame: 4 weeks
description: In order to record the effects of coffee consumption on stress and on sentiments and mood the participants completed the Zung self-assessment anxiety scale and a visual analogue scale every time saliva samples were collected (time 0', 15', 30', 60', 120', 180'). The Zung self-assessment anxiety scale included 20 questions, which were designed to assess how the volunteers felt the moment completing the questionnaire. The visual analogue scale (1 = not at all to 10 = very) included 17 questions about stress, sentiments and mood.
arm group label: Trial 1
arm group type: Experimental
description: Forty healthy men and women, with normal body weight. Volunteers consumed randomly 4 coffee beverages with 160 mg caffeine (hot instant coffee, cold instant coffee, cold espresso, hot filter coffee).
arm group label: Trial 2
arm group type: Experimental
description: Forty healthy men and women, with normal body weight. Volunteers consumed randomly 4 coffee beverages with 160 mg caffeine (hot instant coffee, cold instant coffee, cold espresso, hot filter coffee).
arm group label: Trial 3
arm group type: Experimental
description: Forty healthy men and women, with normal body weight. Volunteers consumed randomly 4 coffee beverages with 160 mg caffeine (hot instant coffee, cold instant coffee, cold espresso, hot filter coffee).
arm group label: Trial 4
arm group type: Experimental
description: Forty healthy men and women, with normal body weight. Volunteers consumed randomly 4 coffee beverages with 160 mg caffeine (hot instant coffee, cold instant coffee, cold espresso, hot filter coffee).
intervention type: Other
intervention name: Cold espresso
description: Volunteers consumed cold espresso with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.
arm group label: Trial 1
arm group label: Trial 2
arm group label: Trial 3
arm group label: Trial 4
other name: Buondi prestige
intervention type: Other
intervention name: Hot instant coffee
description: Volunteers consumed hot instant coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.
arm group label: Trial 1
arm group label: Trial 2
arm group label: Trial 3
arm group label: Trial 4
other name: Nescafé Classic
intervention type: Other
intervention name: Cold instant coffee
description: Volunteers consumed cold instant coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.
arm group label: Trial 1
arm group label: Trial 2
arm group label: Trial 3
arm group label: Trial 4
other name: Nescafé Classic
intervention type: Other
intervention name: Hot filter coffee
description: Volunteers consumed hot filter coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.
arm group label: Trial 1
arm group label: Trial 2
arm group label: Trial 3
arm group label: Trial 4
other name: Nestlé Professional Plantage Filter Coffee
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aimilia Papakonstantinou, PhD
role: Principal Investigator
affiliation: Agricultural University of Athens
responsible party type: Principal Investigator
investigator affiliation: Agricultural University of Athens
investigator full name: Aimilia Papakonstantinou
investigator title: Lecturer of Nutrition and Metabolism
mesh term: Signs and Symptoms, Digestive