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Whole Grains, Gastric Emptying and Glycemic Response

Primary Purpose

Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cracked whole wheat porridge
Semolina wheat porridge
Whole wheat flour porridge
Refined wheat flour porridge
Refined wheat flour porridge,fine bran
Refined wheat flour porridge,coarse bran
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cracked whole wheat porridge

Semolina wheat porridge

Whole wheat flour porridge

Refined wheat flour porridge

Refined wheat flour porridge,fine bran

Refined wheat flour porridge,coarse bran

Arm Description

Large particle whole wheat porridge

Large particle refined wheat porridge

Small particle whole wheat porridge

Small particle refined wheat porridge

Small particle refined wheat porridge with small particle bran

Small particle refined wheat porridge with large particle bran

Outcomes

Primary Outcome Measures

Gastric emptying
Breath test was performed using 13C-octanoic acid mixed into test meals
Glycemic response
Blood glucose was measured using a continuous glucose monitor
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.

Secondary Outcome Measures

Full Information

First Posted
March 10, 2018
Last Updated
March 15, 2018
Sponsor
Purdue University
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1. Study Identification

Unique Protocol Identification Number
NCT03467659
Brief Title
Whole Grains, Gastric Emptying and Glycemic Response
Official Title
Glycemic Response of Whole Grain Wheat Meals
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 16, 2017 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cracked whole wheat porridge
Arm Type
Experimental
Arm Description
Large particle whole wheat porridge
Arm Title
Semolina wheat porridge
Arm Type
Experimental
Arm Description
Large particle refined wheat porridge
Arm Title
Whole wheat flour porridge
Arm Type
Experimental
Arm Description
Small particle whole wheat porridge
Arm Title
Refined wheat flour porridge
Arm Type
Experimental
Arm Description
Small particle refined wheat porridge
Arm Title
Refined wheat flour porridge,fine bran
Arm Type
Experimental
Arm Description
Small particle refined wheat porridge with small particle bran
Arm Title
Refined wheat flour porridge,coarse bran
Arm Type
Experimental
Arm Description
Small particle refined wheat porridge with large particle bran
Intervention Type
Other
Intervention Name(s)
Cracked whole wheat porridge
Intervention Description
Large particle whole wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.
Intervention Type
Other
Intervention Name(s)
Semolina wheat porridge
Intervention Description
Large particle refined wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.
Intervention Type
Other
Intervention Name(s)
Whole wheat flour porridge
Intervention Description
Small particle whole wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.
Intervention Type
Other
Intervention Name(s)
Refined wheat flour porridge
Intervention Description
Small particle refined wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.
Intervention Type
Other
Intervention Name(s)
Refined wheat flour porridge,fine bran
Intervention Description
Small particle refined wheat porridge with small particle bran was tested for gastric emptying rate, glycemic response and appetitive response.
Intervention Type
Other
Intervention Name(s)
Refined wheat flour porridge,coarse bran
Intervention Description
Small particle refined wheat porridge with large particle bran was tested for gastric emptying rate, glycemic response and appetitive response.
Primary Outcome Measure Information:
Title
Gastric emptying
Description
Breath test was performed using 13C-octanoic acid mixed into test meals
Time Frame
Acute study, 4 hours measurement after consumption of test food
Title
Glycemic response
Description
Blood glucose was measured using a continuous glucose monitor
Time Frame
Acute study, 4 hours measurement after consumption of test food
Title
Appetitive behavior
Description
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.
Time Frame
Acute study, 4 hours measurement after consumption of test food.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9097998
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.
Results Reference
background
PubMed Identifier
20443742
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.
Results Reference
background
PubMed Identifier
23777402
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.
Results Reference
background
PubMed Identifier
8500721
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.
Results Reference
background
PubMed Identifier
6776794
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.
Results Reference
background
PubMed Identifier
34999739
Citation
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.
Results Reference
derived

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Whole Grains, Gastric Emptying and Glycemic Response

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