<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/NCT03265392</url>
  </required_header>
  <id_info>
    <org_study_id>DECOUVRIR-M</org_study_id>
    <nct_id>NCT03265392</nct_id>
  </id_info>
  <brief_title>Impact of Food Combination on Starch Digestion and Gastric Processing</brief_title>
  <acronym>DECOUVRIR-M</acronym>
  <official_title>Digestion: Building a Better Health and Better Understanding the Digestive Processes Thanks to Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>IR4M (Imagerie par Résonance Magnétique Médicale et Multi-Modalités)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement</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 results of our in vitro studies strengthen the hypothesis that the contribution of&#xD;
      salivary alpha-amylase to starch digestion has been underrated and that this enzyme can play&#xD;
      an important role in this process. As a result, its inhibition could constitute an&#xD;
      opportunity to reduce the glycemic response elicited by starch-rich foods. The main goal of&#xD;
      this study is to verify whether inhibiting salivary alpha-amylase upon the consumption of&#xD;
      starchy foods, can have an impact on the postprandial glycemic response, and/or satiety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of this work was to test the impact of adding black tea or lemon juice to&#xD;
      a starch-rich meal on postprandial plasma glucose concentrations and on energy intake in&#xD;
      healthy humans. This study was divided into two parts.&#xD;
&#xD;
      The objective of part 1 was to determine the effect of pairing a starch-rich food with water,&#xD;
      black tea or lemon juice on postprandial plasma glucose and energy intake in healthy humans.&#xD;
      This study was conducted in semi-controlled conditions. The three test meals (equal portions&#xD;
      of bread (100 g) and 250 mL of either water, black tea or lemon juice) were consumed as&#xD;
      breakfast (after a 10-h fast) on independent days and in a randomised order. Capillary blood&#xD;
      glucose concentrations were self-monitored using the finger-prick method at pre-defined&#xD;
      time-points during 180 min. Ad libitum energy intake was assessed 3 hours later.&#xD;
&#xD;
      The main objective of part 2 was to investigate whether the gastric emptying patterns remain,&#xD;
      or not, the same when a bread meal is paired with water, tea, and lemon juice. Blood glucose&#xD;
      response and satiety perceptions were also monitored. The test meals were similar to those in&#xD;
      branch 1, except that the meals were supplemented with 20 peas, which the subjects were asked&#xD;
      to swallow at the end (with half of the beverage provided) without chewing. These peas&#xD;
      conferred a distinct contrast in MRI scans and could be used as stomach motility and gastric&#xD;
      mixing tracers in MRI images. Capillary blood glucose concentrations were determined using&#xD;
      the finger-prick method at pre-defined time-points during 180 min. Visual analogue scales&#xD;
      were used to assess satiety-related perceptions.&#xD;
&#xD;
      Volunteer recruitment was conducted independently for each part of the study and volunteers&#xD;
      were allowed to participate in one part of the study only. Data collected in each part of the&#xD;
      study was analysed independently.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2018</start_date>
  <completion_date type="Actual">July 6, 2018</completion_date>
  <primary_completion_date type="Actual">July 6, 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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Energy intake (Main outcome of Part 1)</measure>
    <time_frame>3 hours</time_frame>
    <description>Consumption at an ad libitum meal served 3 h after each test-meal during part 1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastric emptying (Main outcome of Part 2)</measure>
    <time_frame>3 hours</time_frame>
    <description>Gastric empting kinetics of each test-meal, evaluated by MRI, during part 2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycemic Response (Secondary outcome of Parts 1 and 2)</measure>
    <time_frame>At baseline and and at different time-points during 3 hours after after consuming the test meal</time_frame>
    <description>Capillary blood glucose monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective appetite sensations (Secondary outcome of Part 2)</measure>
    <time_frame>At baseline and at different time-points during 3 hours after consuming the test meal</time_frame>
    <description>Evaluation of satiety, fullness, hunger, prospective food consumption and desire to eat through visual analogue scales (VAS)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>End of the day questionnaire</measure>
    <time_frame>12-16 hours after the test meal (Part 1 and 2)</time_frame>
    <description>Digital questionnaire that will be answered at the end of the day in order to provide a reference point regarding the potential effects of the test-meal throughout the rest of the day (ex. appetite, food consumption, discomfort sensations)</description>
  </other_outcome>
  <other_outcome>
    <measure>Gastric contractions</measure>
    <time_frame>At baseline and during 3 hours after after consuming the test meal (Part 2 only)</time_frame>
    <description>Analysis of MRI scans will be carried out to evaluate the frequency of gastric contractions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Amylolytic activity of saliva</measure>
    <time_frame>At baseline (Part 1)</time_frame>
    <description>The amylolytic activity of saliva samples collected before the test meal will be determined.</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Glycemic Index</condition>
  <condition>Gastric Emptying</condition>
  <condition>Appetite</condition>
  <arm_group>
    <arm_group_label>Part 1 - Bread + Water</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in this arm will randomly consume bread and 250 mL of water on 1 out of 3 visits of Part 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 - Bread + Lemon Juice</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in this arm will randomly consume bread and 250 mL of lemon juice on 1 out of 3 visits of Part 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 - Bread + Tea</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in this arm will randomly consume bread and 250 mL of tea on 1 out of 3 visits of Part 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 - Bread + water</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in this arm will randomly consume bread and 250 mL of water supplemented with 20 peas on 1 out of 3 visits of Part 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 - Bread+ Lemon Juice</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in this arm will randomly consume bread and 250 mL of lemon juice supplemented with 20 peas on 1 out of 3 visits of Part 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 - Bread+ tea</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in this arm will randomly consume bread and 250 mL of tea supplemented with 20 peas on 1 out of 3 visits of Part 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bread</intervention_name>
    <description>Serving of wheat bread providing 50 g of carbohydrates</description>
    <arm_group_label>Part 1 - Bread + Lemon Juice</arm_group_label>
    <arm_group_label>Part 1 - Bread + Tea</arm_group_label>
    <arm_group_label>Part 1 - Bread + Water</arm_group_label>
    <arm_group_label>Part 2 - Bread + water</arm_group_label>
    <arm_group_label>Part 2 - Bread+ Lemon Juice</arm_group_label>
    <arm_group_label>Part 2 - Bread+ tea</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Water</intervention_name>
    <description>250 mL of water</description>
    <arm_group_label>Part 1 - Bread + Water</arm_group_label>
    <arm_group_label>Part 2 - Bread + water</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lemon juice</intervention_name>
    <description>250 mL of lemon juice</description>
    <arm_group_label>Part 1 - Bread + Lemon Juice</arm_group_label>
    <arm_group_label>Part 2 - Bread+ Lemon Juice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tea</intervention_name>
    <description>250 mL of tea</description>
    <arm_group_label>Part 1 - Bread + Tea</arm_group_label>
    <arm_group_label>Part 2 - Bread+ tea</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Peas</intervention_name>
    <description>20 peas</description>
    <arm_group_label>Part 2 - Bread + water</arm_group_label>
    <arm_group_label>Part 2 - Bread+ Lemon Juice</arm_group_label>
    <arm_group_label>Part 2 - Bread+ tea</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To be overall healthy&#xD;
&#xD;
          -  To be between 18 and 60 years old&#xD;
&#xD;
          -  BMI between 18 and 25 (lean)&#xD;
&#xD;
          -  No eating disorders&#xD;
&#xD;
          -  No major weight changes (&gt; 3kg in previous 3 months)&#xD;
&#xD;
          -  Structured eating habits (3 main meals/day, everyday)&#xD;
&#xD;
          -  Not using corticoid drugs, or antidepressives known to influence food consumption,&#xD;
             appetite and/or mood.&#xD;
&#xD;
          -  Not using medication known to influence glucose tolerance: acetylsalicylic acid or&#xD;
             thyroxin, vitamin or mineral-based dietary supplements, and drugs to control&#xD;
             hypertension or osteoporosis are acceptable&#xD;
&#xD;
          -  No allergies to the foods in the test-meals and ad libitum meal&#xD;
&#xD;
          -  No abusive alcohol consumption&#xD;
&#xD;
          -  No intensive exercising habits&#xD;
&#xD;
          -  No participation in a clinical study within the previous 6 months&#xD;
&#xD;
          -  To enjoy the foods in the test-meals and ad libitum meals&#xD;
&#xD;
          -  To be affiliated to a social security system&#xD;
&#xD;
          -  To be available to participate in study sessions&#xD;
&#xD;
          -  To have read and signed the Informed consent form&#xD;
&#xD;
        Additional criteria for Part 2&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Ability to be in an MRI scan without moving&#xD;
&#xD;
          -  Ability to hold breath for 25s (a requirement for certain MRI exams)&#xD;
&#xD;
        Non-inclusion criteria:&#xD;
&#xD;
          -  History of diabetes, use of antihyperglycemic drugs or insulin to treat diabetes or&#xD;
             associated conditions&#xD;
&#xD;
          -  Major medical interventions or surgeries requiring hospitalization within the previous&#xD;
             3 months&#xD;
&#xD;
          -  Any medical condition that affects digestion and/or nutrient absorption&#xD;
&#xD;
          -  Use of steroids, protease inhibitors and/or antipsychotic drugs&#xD;
&#xD;
          -  Use of anticoagulation drugs&#xD;
&#xD;
          -  To be participating in another clinical trial, or to be within the exclusion period of&#xD;
             a previous clinical trial&#xD;
&#xD;
          -  To have started or stopped smoking within the previous 3 months&#xD;
&#xD;
        Additional exclusion criteria for Part 2:&#xD;
&#xD;
          -  Any contraindications to an MRI exam: claustrophobia, tatoos, presence of&#xD;
             ferromagnetic elements, having a pacemaker, metallic prosthesis, cochlear implants,&#xD;
             vascular clips, insulin pumps&#xD;
&#xD;
          -  Any condition or disease that might affect the results of MRI exams.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Benamouzig, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre de Recherche sur Volontaires (CRV), Hospital Avicenne</name>
      <address>
        <city>Bobigny</city>
        <state>Ile-de-France</state>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>June 5, 2019</last_update_submitted>
  <last_update_submitted_qc>June 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement</investigator_affiliation>
    <investigator_full_name>Robert Benamouzig</investigator_full_name>
    <investigator_title>Professor, MD, PhD</investigator_title>
  </responsible_party>
  <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/NCT03265392
org study id: DECOUVRIR-M
nct id: NCT03265392
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The results of our in vitro studies strengthen the hypothesis that the contribution of
      salivary alpha-amylase to starch digestion has been underrated and that this enzyme can play
      an important role in this process. As a result, its inhibition could constitute an
      opportunity to reduce the glycemic response elicited by starch-rich foods. The main goal of
      this study is to verify whether inhibiting salivary alpha-amylase upon the consumption of
      starchy foods, can have an impact on the postprandial glycemic response, and/or satiety.
The main objective of this work was to test the impact of adding black tea or lemon juice to
      a starch-rich meal on postprandial plasma glucose concentrations and on energy intake in
      healthy humans. This study was divided into two parts.

      The objective of part 1 was to determine the effect of pairing a starch-rich food with water,
      black tea or lemon juice on postprandial plasma glucose and energy intake in healthy humans.
      This study was conducted in semi-controlled conditions. The three test meals (equal portions
      of bread (100 g) and 250 mL of either water, black tea or lemon juice) were consumed as
      breakfast (after a 10-h fast) on independent days and in a randomised order. Capillary blood
      glucose concentrations were self-monitored using the finger-prick method at pre-defined
      time-points during 180 min. Ad libitum energy intake was assessed 3 hours later.

      The main objective of part 2 was to investigate whether the gastric emptying patterns remain,
      or not, the same when a bread meal is paired with water, tea, and lemon juice. Blood glucose
      response and satiety perceptions were also monitored. The test meals were similar to those in
      branch 1, except that the meals were supplemented with 20 peas, which the subjects were asked
      to swallow at the end (with half of the beverage provided) without chewing. These peas
      conferred a distinct contrast in MRI scans and could be used as stomach motility and gastric
      mixing tracers in MRI images. Capillary blood glucose concentrations were determined using
      the finger-prick method at pre-defined time-points during 180 min. Visual analogue scales
      were used to assess satiety-related perceptions.

      Volunteer recruitment was conducted independently for each part of the study and volunteers
      were allowed to participate in one part of the study only. Data collected in each part of the
      study was analysed independently.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Energy intake (Main outcome of Part 1)
time frame: 3 hours
description: Consumption at an ad libitum meal served 3 h after each test-meal during part 1
measure: Gastric emptying (Main outcome of Part 2)
time frame: 3 hours
description: Gastric empting kinetics of each test-meal, evaluated by MRI, during part 2
measure: Glycemic Response (Secondary outcome of Parts 1 and 2)
time frame: At baseline and and at different time-points during 3 hours after after consuming the test meal
description: Capillary blood glucose monitoring
measure: Subjective appetite sensations (Secondary outcome of Part 2)
time frame: At baseline and at different time-points during 3 hours after consuming the test meal
description: Evaluation of satiety, fullness, hunger, prospective food consumption and desire to eat through visual analogue scales (VAS)
measure: End of the day questionnaire
time frame: 12-16 hours after the test meal (Part 1 and 2)
description: Digital questionnaire that will be answered at the end of the day in order to provide a reference point regarding the potential effects of the test-meal throughout the rest of the day (ex. appetite, food consumption, discomfort sensations)
measure: Gastric contractions
time frame: At baseline and during 3 hours after after consuming the test meal (Part 2 only)
description: Analysis of MRI scans will be carried out to evaluate the frequency of gastric contractions.
measure: Amylolytic activity of saliva
time frame: At baseline (Part 1)
description: The amylolytic activity of saliva samples collected before the test meal will be determined.
arm group label: Part 1 - Bread + Water
arm group type: Other
description: Participants in this arm will randomly consume bread and 250 mL of water on 1 out of 3 visits of Part 1.
arm group label: Part 1 - Bread + Lemon Juice
arm group type: Other
description: Participants in this arm will randomly consume bread and 250 mL of lemon juice on 1 out of 3 visits of Part 1.
arm group label: Part 1 - Bread + Tea
arm group type: Other
description: Participants in this arm will randomly consume bread and 250 mL of tea on 1 out of 3 visits of Part 1.
arm group label: Part 2 - Bread + water
arm group type: Other
description: Participants in this arm will randomly consume bread and 250 mL of water supplemented with 20 peas on 1 out of 3 visits of Part 2.
arm group label: Part 2 - Bread+ Lemon Juice
arm group type: Other
description: Participants in this arm will randomly consume bread and 250 mL of lemon juice supplemented with 20 peas on 1 out of 3 visits of Part 2.
arm group label: Part 2 - Bread+ tea
arm group type: Other
description: Participants in this arm will randomly consume bread and 250 mL of tea supplemented with 20 peas on 1 out of 3 visits of Part 2.
intervention type: Other
intervention name: Bread
description: Serving of wheat bread providing 50 g of carbohydrates
arm group label: Part 1 - Bread + Lemon Juice
arm group label: Part 1 - Bread + Tea
arm group label: Part 1 - Bread + Water
arm group label: Part 2 - Bread + water
arm group label: Part 2 - Bread+ Lemon Juice
arm group label: Part 2 - Bread+ tea
intervention type: Other
intervention name: Water
description: 250 mL of water
arm group label: Part 1 - Bread + Water
arm group label: Part 2 - Bread + water
intervention type: Other
intervention name: Lemon juice
description: 250 mL of lemon juice
arm group label: Part 1 - Bread + Lemon Juice
arm group label: Part 2 - Bread+ Lemon Juice
intervention type: Other
intervention name: Tea
description: 250 mL of tea
arm group label: Part 1 - Bread + Tea
arm group label: Part 2 - Bread+ tea
intervention type: Other
intervention name: Peas
description: 20 peas
arm group label: Part 2 - Bread + water
arm group label: Part 2 - Bread+ Lemon Juice
arm group label: Part 2 - Bread+ tea
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Benamouzig, MD, PhD
role: Principal Investigator
affiliation: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
investigator full name: Robert Benamouzig
investigator title: Professor, MD, PhD
sharing ipd: No