Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03630263 |
| Other study ID # |
IRB-2019-206 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2019 |
| Est. completion date |
April 1, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Purdue University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
