- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03467659
Whole Grains, Gastric Emptying and Glycemic Response
March 15, 2018 updated by: Bruce R. Hamaker, Purdue University
Glycemic Response of Whole Grain Wheat Meals
Whole grains have been associated with controlled glycemic response and increased satiety compared to refined grains.
However, the properties of whole grains which are responsible for these purported improved health outcomes are still unclear.
The current study investigated the extent of whole grains' low glycemic property when food properties are controlled, and how this relates to gastric emptying rate and glycemic response.
Study Overview
Status
Completed
Conditions
Detailed Description
It is generally assumed that whole grain foods confer a health benefit in regards to moderated glycemia and increased satiety compared to foods made from refined grains.
However, the extent of whole grains' low glycemic property may be limited by certain factors.
For example, physical properties such as viscosity or particle size and differing starch digestion rates of whole grain foods may strongly influence glycemic response and gastric emptying rate.
In this study, whole and refined grain wheat porridges were prepared from materials originating from the same milling source, with matched pairs for viscosity, starch and dietary fiber contents, and particle size.
Subjects consumed wheat porridges containing 13C-labeled octanoic acid for assessment of gastric emptying rate, and they wore a continuous glucose monitor for measuring postprandial glucose levels.
The purpose of this research was to test the hypothesis that the purported moderated glycemic response and slow gastric emptying rate are dependent on how these foods are processed.
This work highlights the need to consider specific properties of whole grain foods for desired health outcomes in order to optimize the design of whole grain-based foods.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
West Lafayette, Indiana, United States, 47907
- Purdue University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged between 18-50 years old
- Healthy, normal BMI (18.5 kg/m² <BMI < 25 kg/m²)
- Be free of any gastrointestinal diseases, diabetes, cardiovascular diseases
- Be free of any wheat allergies and gluten intolerances or sensitivities
- Not be pregnant or nursing
Exclusion Criteria:
- No medical problems
- No medication
- Pregnant or nursing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cracked whole wheat porridge
Large particle whole wheat porridge
|
Large particle whole wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.
|
|
Experimental: Semolina wheat porridge
Large particle refined wheat porridge
|
Large particle refined wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.
|
|
Experimental: Whole wheat flour porridge
Small particle whole wheat porridge
|
Small particle whole wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.
|
|
Experimental: Refined wheat flour porridge
Small particle refined wheat porridge
|
Small particle refined wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.
|
|
Experimental: Refined wheat flour porridge,fine bran
Small particle refined wheat porridge with small particle bran
|
Small particle refined wheat porridge with small particle bran was tested for gastric emptying rate, glycemic response and appetitive response.
|
|
Experimental: Refined wheat flour porridge,coarse bran
Small particle refined wheat porridge with large particle bran
|
Small particle refined wheat porridge with large particle bran was tested for gastric emptying rate, glycemic response and appetitive response.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gastric emptying
Time Frame: Acute study, 4 hours measurement after consumption of test food
|
Breath test was performed using 13C-octanoic acid mixed into test meals
|
Acute study, 4 hours measurement after consumption of test food
|
|
Glycemic response
Time Frame: Acute study, 4 hours measurement after consumption of test food
|
Blood glucose was measured using a continuous glucose monitor
|
Acute study, 4 hours measurement after consumption of test food
|
|
Appetitive behavior
Time Frame: Acute study, 4 hours measurement after consumption of test food.
|
Hunger and fullness scores using a 10 cm scale (0 = weakest feeling of hunger or fullness and 10 = highest feeling of hunger or fullness) will be taken after each meal.
|
Acute study, 4 hours measurement after consumption of test food.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- Christiansen M, Bailey T, Watkins E, Liljenquist D, Price D, Nakamura K, Boock R, Peyser T. A new-generation continuous glucose monitoring system: improved accuracy and reliability compared with a previous-generation system. Diabetes Technol Ther. 2013 Oct;15(10):881-8. doi: 10.1089/dia.2013.0077. Epub 2013 Jun 18.
- 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.
- Pletsch EA, Hayes AMR, Chegeni M, Hamaker BR. Matched whole grain wheat and refined wheat milled products do not differ in glycemic response or gastric emptying in a randomized, crossover trial. Am J Clin Nutr. 2022 Apr 1;115(4):1013-1026. doi: 10.1093/ajcn/nqab434.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 16, 2017
Primary Completion (Actual)
May 31, 2017
Study Completion (Actual)
May 31, 2017
Study Registration Dates
First Submitted
March 10, 2018
First Submitted That Met QC Criteria
March 10, 2018
First Posted (Actual)
March 16, 2018
Study Record Updates
Last Update Posted (Actual)
March 19, 2018
Last Update Submitted That Met QC Criteria
March 15, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1611018484
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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