<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/NCT03007368</url>
  </required_header>
  <id_info>
    <org_study_id>1104010761</org_study_id>
    <nct_id>NCT03007368</nct_id>
  </id_info>
  <brief_title>Digestion of Foods Consumed in Africa</brief_title>
  <official_title>Assessment of Gastric Emptying and Fullness of Different Types of Foods in Mali</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Purdue University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Purdue University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      As populations become urbanized in Africa, the change to a more Westernized diet has been&#xD;
      associated with rise in obesity and related metabolic syndrome diseases. The current study&#xD;
      shows that in the West African Sahel, these replacement starchy staple foods have fast&#xD;
      gastric emptying compared to traditional sorghum and millet foods; and implies that the&#xD;
      latter could be beneficial in lowering glycemic response, providing energy from a meal over a&#xD;
      longer time, and providing a satiety effect. Knowledge of this attribute of sorghum and&#xD;
      millet foods could be useful to improve their image in West African cities to increase their&#xD;
      consumption and to improve markets for local smallholder farmers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As suggested by anecdotal evidence that traditional Malian sorghum and millet foods are&#xD;
      filling and provide sustained energy, we hypothesized that gastric emptying rates of sorghum&#xD;
      and millet foods are slow, particularly compared to non-traditional starchy foods (white&#xD;
      rice, potato, wheat pasta) that are now commonly consumed in urban areas of the West African&#xD;
      Sahel. A broader purpose for the study was to understand whether sorghum and millet foods&#xD;
      have positive health attributes that can be promoted in urban areas to provide better markets&#xD;
      for local farmers.&#xD;
&#xD;
      Two human trials of similar design were conducted approximately one year apart. The carbon 13&#xD;
      (13C)-labelled octanoic acid breath test method was used to measure gastric emptying rate,&#xD;
      and subjective pre-test and satiety response questionnaires were used. In the first study, 14&#xD;
      healthy volunteers in Bamako, Mali participated in a crossover design to test eight starchy&#xD;
      foods for gastric emptying rate and satiety feelings. The second study with six volunteers&#xD;
      was done to correct for endogenous 13C differences in the starch component of the foods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gastric emptying</measure>
    <time_frame>acute study, 4 hours after consumption of test food</time_frame>
    <description>Breath test was performed using 13C-octanoic acid mixed into test meals</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Appetitive response</measure>
    <time_frame>acute study, 4 hours after consumption of test food</time_frame>
    <description>Fullness and hunger questionnaire was given at various time points after consumption of test foods</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Obesity and Other Hyperalimentation</condition>
  <arm_group>
    <arm_group_label>Rice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cooked white rice and tomato-based sauce</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Potato</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cooked white peeled potato and tomato-based sauce</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pasta</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cooked macaroni product and tomato-based sauce</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sorghum thick porridge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sorghum thick porridge and tomato-based sauce</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Millet thick porridge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Millet thick porridge and tomato-based sauce</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Millet couscous</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cooked millet couscous and tomato-based sauce</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Millet thin porridge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Millet thin porridge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Millet thin monikuru porridge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Millet thin porridge containing cooked millet granules (monikuru)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rice</intervention_name>
    <description>Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.</description>
    <arm_group_label>Rice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Potato</intervention_name>
    <description>Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response .</description>
    <arm_group_label>Potato</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pasta</intervention_name>
    <description>Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.</description>
    <arm_group_label>Pasta</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sorghum thick porridge</intervention_name>
    <description>Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.</description>
    <arm_group_label>Sorghum thick porridge</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Millet thick porridge</intervention_name>
    <description>Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.</description>
    <arm_group_label>Millet thick porridge</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Millet couscous</intervention_name>
    <description>Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.</description>
    <arm_group_label>Millet couscous</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Millet thin porridge</intervention_name>
    <description>Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.</description>
    <arm_group_label>Millet thin porridge</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Millet thin monikuru porridge</intervention_name>
    <description>Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.</description>
    <arm_group_label>Millet thin monikuru porridge</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal body mass index (18 kg/m2 ≤ BMI ≤ 25 kg/m2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under any medication&#xD;
&#xD;
          -  History of any gastrointestinal disease or surgery&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Smoker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Ghoos YF, Maes BD, Geypens BJ, Mys G, Hiele MI, Rutgeerts PJ, Vantrappen G. Measurement of gastric emptying rate of solids by means of a carbon-labeled octanoic acid breath test. Gastroenterology. 1993 Jun;104(6):1640-7. doi: 10.1016/0016-5085(93)90640-x.</citation>
    <PMID>8500721</PMID>
  </reference>
  <reference>
    <citation>Choi MG, Camilleri M, Burton DD, Zinsmeister AR, Forstrom LA, Nair KS. [13C]octanoic acid breath test for gastric emptying of solids: accuracy, reproducibility, and comparison with scintigraphy. Gastroenterology. 1997 Apr;112(4):1155-62. doi: 10.1016/s0016-5085(97)70126-4.</citation>
    <PMID>9097998</PMID>
  </reference>
  <reference>
    <citation>Clegg ME, Shafat A. Procedures in the 13C octanoic acid breath test for measurement of gastric emptying: analysis using Bland-Altman methods. Scand J Gastroenterol. 2010 Aug;45(7-8):852-61. doi: 10.3109/00365521.2010.483740.</citation>
    <PMID>20443742</PMID>
  </reference>
  <reference>
    <citation>Schoeller DA, Klein PD, Watkins JB, Heim T, MacLean WC Jr. 13C abundances of nutrients and the effect of variations in 13C isotopic abundances of test meals formulated for 13CO2 breath tests. Am J Clin Nutr. 1980 Nov;33(11):2375-85. doi: 10.1093/ajcn/33.11.2375.</citation>
    <PMID>6776794</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Purdue University</investigator_affiliation>
    <investigator_full_name>Bruce R. Hamaker</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperphagia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not shared</ipd_description>
  </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/NCT03007368
org study id: 1104010761
nct id: NCT03007368
lead sponsor: 
collaborator: 
has dmc: No
As populations become urbanized in Africa, the change to a more Westernized diet has been
      associated with rise in obesity and related metabolic syndrome diseases. The current study
      shows that in the West African Sahel, these replacement starchy staple foods have fast
      gastric emptying compared to traditional sorghum and millet foods; and implies that the
      latter could be beneficial in lowering glycemic response, providing energy from a meal over a
      longer time, and providing a satiety effect. Knowledge of this attribute of sorghum and
      millet foods could be useful to improve their image in West African cities to increase their
      consumption and to improve markets for local smallholder farmers.
As suggested by anecdotal evidence that traditional Malian sorghum and millet foods are
      filling and provide sustained energy, we hypothesized that gastric emptying rates of sorghum
      and millet foods are slow, particularly compared to non-traditional starchy foods (white
      rice, potato, wheat pasta) that are now commonly consumed in urban areas of the West African
      Sahel. A broader purpose for the study was to understand whether sorghum and millet foods
      have positive health attributes that can be promoted in urban areas to provide better markets
      for local farmers.

      Two human trials of similar design were conducted approximately one year apart. The carbon 13
      (13C)-labelled octanoic acid breath test method was used to measure gastric emptying rate,
      and subjective pre-test and satiety response questionnaires were used. In the first study, 14
      healthy volunteers in Bamako, Mali participated in a crossover design to test eight starchy
      foods for gastric emptying rate and satiety feelings. The second study with six volunteers
      was done to correct for endogenous 13C differences in the starch component of the foods.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Gastric emptying
time frame: acute study, 4 hours after consumption of test food
description: Breath test was performed using 13C-octanoic acid mixed into test meals
measure: Appetitive response
time frame: acute study, 4 hours after consumption of test food
description: Fullness and hunger questionnaire was given at various time points after consumption of test foods
arm group label: Rice
arm group type: Experimental
description: Cooked white rice and tomato-based sauce
arm group label: Potato
arm group type: Experimental
description: Cooked white peeled potato and tomato-based sauce
arm group label: Pasta
arm group type: Experimental
description: Cooked macaroni product and tomato-based sauce
arm group label: Sorghum thick porridge
arm group type: Experimental
description: Sorghum thick porridge and tomato-based sauce
arm group label: Millet thick porridge
arm group type: Experimental
description: Millet thick porridge and tomato-based sauce
arm group label: Millet couscous
arm group type: Experimental
description: Cooked millet couscous and tomato-based sauce
arm group label: Millet thin porridge
arm group type: Experimental
description: Millet thin porridge
arm group label: Millet thin monikuru porridge
arm group type: Experimental
description: Millet thin porridge containing cooked millet granules (monikuru)
intervention type: Other
intervention name: Rice
description: Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
arm group label: Rice
intervention type: Other
intervention name: Potato
description: Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response .
arm group label: Potato
intervention type: Other
intervention name: Pasta
description: Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
arm group label: Pasta
intervention type: Other
intervention name: Sorghum thick porridge
description: Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
arm group label: Sorghum thick porridge
intervention type: Other
intervention name: Millet thick porridge
description: Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
arm group label: Millet thick porridge
intervention type: Other
intervention name: Millet couscous
description: Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
arm group label: Millet couscous
intervention type: Other
intervention name: Millet thin porridge
description: Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
arm group label: Millet thin porridge
intervention type: Other
intervention name: Millet thin monikuru porridge
description: Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
arm group label: Millet thin monikuru porridge
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Ghoos YF, Maes BD, Geypens BJ, Mys G, Hiele MI, Rutgeerts PJ, Vantrappen G. Measurement of gastric emptying rate of solids by means of a carbon-labeled octanoic acid breath test. Gastroenterology. 1993 Jun;104(6):1640-7. doi: 10.1016/0016-5085(93)90640-x.
PMID: 8500721
citation: Choi MG, Camilleri M, Burton DD, Zinsmeister AR, Forstrom LA, Nair KS. [13C]octanoic acid breath test for gastric emptying of solids: accuracy, reproducibility, and comparison with scintigraphy. Gastroenterology. 1997 Apr;112(4):1155-62. doi: 10.1016/s0016-5085(97)70126-4.
PMID: 9097998
citation: Clegg ME, Shafat A. Procedures in the 13C octanoic acid breath test for measurement of gastric emptying: analysis using Bland-Altman methods. Scand J Gastroenterol. 2010 Aug;45(7-8):852-61. doi: 10.3109/00365521.2010.483740.
PMID: 20443742
citation: Schoeller DA, Klein PD, Watkins JB, Heim T, MacLean WC Jr. 13C abundances of nutrients and the effect of variations in 13C isotopic abundances of test meals formulated for 13CO2 breath tests. Am J Clin Nutr. 1980 Nov;33(11):2375-85. doi: 10.1093/ajcn/33.11.2375.
PMID: 6776794
responsible party type: Principal Investigator
investigator affiliation: Purdue University
investigator full name: Bruce R. Hamaker
investigator title: Professor
mesh term: Hyperphagia
sharing ipd: No
ipd description: Not shared