Whole Grains, Gastric Emptying and Glycemic Response

Obesity Clinical Trial

Official title:

Glycemic Response of Whole Grain Wheat Meals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03467659
• Other study ID #: 1611018484
• Status: Completed
• Phase: N/A
• First received: March 10, 2018
• Last updated: March 15, 2018
• Start date: February 16, 2017
• Est. completion date: May 31, 2017

Study information

• Verified date: March 2018
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetitive Behavior
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Other:
• Cracked whole wheat porridge
Large particle whole wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.
• Semolina wheat porridge
Large particle refined wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.
• Whole wheat flour porridge
Small particle whole wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.
• Refined wheat flour porridge
Small particle refined wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.
• Refined wheat flour porridge,fine bran
Small particle refined wheat porridge with small particle bran was tested for gastric emptying rate, glycemic response and appetitive response.
• Refined wheat flour porridge,coarse bran
Small particle refined wheat porridge with large particle bran was tested for gastric emptying rate, glycemic response and appetitive response.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric emptying	Breath test was performed using 13C-octanoic acid mixed into test meals	Acute study, 4 hours measurement after consumption of test food
Primary	Glycemic response	Blood glucose was measured using a continuous glucose monitor	Acute study, 4 hours measurement after consumption of test food
Primary	Appetitive behavior	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.