This Study Assessed the Impact of Diet on Gastric Emptying Time and Metabolic Flexibility
Condition: Obesity; Diabetes Mellitus, Type 2; Appetitive Behavior
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Consumption of slowly digestible carbohydrates can elicit higher satiety feeling compared to
      rapidly digestible carbohydrates, however not all individuals respond the same. The
      physiological mechanism that accounts for the satiety effect and the lack of consistency
      among subjects is not fully understood. The overall aim of this research is to determine if
      consumption of slow digestible carbohydrates can induce non-responding subjects (i.e., with
      rapid gastric emptying) to activate the ileal brake and delay rate of gastric emptying.
    

Detailed description: 
      The purpose of this study is to understand how diet may affect carbohydrate digestion,
      gastric emptying time and overall health. The investigators will be recruiting 32 volunteers
      for this study. To be eligible for this study, you need to be between 18 and 50 years old,
      have a normal Body Mass Index, have a normal fasting blood glucose level, be free of any
      gastrointestinal diseases, diabetes, cardiovascular diseases, be free of wheat allergens,
      gluten intolerance or sensitivities, and allergy to millet, and not be pregnant or nursing.
      If you have any questions about the criteria, please ask the person consenting you.

      In this study, participants will consume two test meals at different times to assess gastric
      emptying times. Test meals will consist of either corn starch (30 g) or pregelatinized (DE-1
      Maltodextrin) starch in applesauce (200 g) with xanthan gum (0.2 g) to equalize viscosity.
      Ingredients will be mixed immediately before consumption. For assessment of gastric emptying
      time, we will use a non-invasive 13C-labeled octanoic acid breath test. In our proposed
      procedure, 13C octanoic acid will be added to test meals, and breath samples will be taken
      before and after ingestion up to 4 hours. Breath samples will be collected every 15 minutes
      for first 2 hours and every 30 minutes for the next 2 hours. Participants will breathe into
      300 mL bags and their content will be evaluated for [13C] using a 13CO2 Urea Breath Analyzer
      POCone (Otsuka Electronics Co, Ltd, Osaka, Japan) as measures of gastric emptying. We have
      used the labeled substrate and breath collection methods in our lab under previously approved
      IRB protocols at Purdue University (IRB Protocols #1102010450, #1104010761, #1209012595,
      #1405014904, and #1502015807, #1611018484, #1706019377. In addition, before, during, and
      after each session, subjects will also be asked to fill out a short questionnaire with
      questions regarding your hunger and fullness at those times. Test meals will be prepared in
      the university with trained personnel. All the ingredients will be purchased from approved
      food manufacturers.

      During testing days participants will be required to stay in the laboratory. Testing day
      sessions will last about 4 hours. The day prior testing, participants will be provided a
      standard meal but are not required to stay.

      For assessment of diet composition, three 24-hour dietary recalls will be used. Participants
      will be called on three different days. During these sessions, participants will be asked to
      recount quantity and types of foods consumed throughout the day, including two weekdays and
      one weekend day, to form a comprehensive picture of their dietary habits. Dietary data will
      be collected and stored using no personally identifiable information.

      The purpose of this study is to evaluate the continuous effect of slowly digestible
      carbohydrates consumption on gastric emptying and its potential health benefits.
    

Intervention name(s): Raw Corn Starch; No Raw Corn Starch
Intervention type(s): Other; Other
Intervention description(s): Raw corn starch (30 g) will be added to 200 g of applesauce and served to participants, gastric emptying rate, and postprandial glucose will be measured.; 200 g of applesauce will be consumed and gastric emptying rate, and postprandial glucose will be measured.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Repeated measures ANOVA, within factors.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Gastric emptying; Postprandial blood glucose