ClinicalTrials.gg
CompletedNCT03467659Updated Mar 19, 2018

Whole Grains, Gastric Emptying and Glycemic Response

An interventional study of Cracked whole wheat porridge and Semolina wheat porridge in Obesity, Diabetes Mellitus, Type 2 and Appetitive Behavior, sponsored by Purdue University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-19.

Sponsored by Purdue University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Feb 2017, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity
  • Diabetes Mellitus, Type 2
  • Appetitive Behavior
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 16 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Purdue University is the lead sponsor of 175 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged between 18-50 years old
  • Healthy, normal (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

Exclusion Criteria:

  • No medical problems
  • No medication
  • Pregnant or nursing
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Cracked whole wheat porridge

    Large particle whole wheat porridge

    Other: Cracked whole wheat porridge

  • Experimental
    Semolina wheat porridge

    Large particle refined wheat porridge

    Other: Semolina wheat porridge

  • Experimental
    Whole wheat flour porridge

    Small particle whole wheat porridge

    Other: Whole wheat flour porridge

  • Experimental
    Refined wheat flour porridge

    Small particle refined wheat porridge

    Other: Refined wheat flour porridge

  • Experimental
    Refined wheat flour porridge,fine bran

    Small particle refined wheat porridge with small particle bran

    Other: Refined wheat flour porridge,fine bran

  • Experimental
    Refined wheat flour porridge,coarse bran

    Small particle refined wheat porridge with large particle bran

    Other: Refined wheat flour porridge,coarse bran

Interventions

  • OtherCracked whole wheat porridge

    Large particle whole wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.

  • OtherSemolina wheat porridge

    Large particle refined wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.

  • OtherWhole wheat flour porridge

    Small particle whole wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.

  • OtherRefined wheat flour porridge

    Small particle refined wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.

  • OtherRefined 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.

  • OtherRefined 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.

06

What researchers measure

Primary outcomes

  1. Gastric emptying

    Breath test was performed using 13C-octanoic acid mixed into test meals

    Time frame: Acute study, 4 hours measurement after consumption of test food

  2. Glycemic response

    Blood glucose was measured using a continuous glucose monitor

    Time frame: Acute study, 4 hours measurement after consumption of test food

  3. 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.

    Time frame: Acute study, 4 hours measurement after consumption of test food.

07

Study locations

1 site
  • Purdue University
    West Lafayette, Indiana 47907, United States
08

References and documents

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. PubMed 9097998 ↗
  • 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. PubMed 20443742 ↗
  • 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. PubMed 23777402 ↗
  • 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. PubMed 8500721 ↗
  • 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. PubMed 6776794 ↗
  • 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. PubMed 34999739 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2017 to primary completion in May 2017, 3 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 3 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 10, 2018
First posted
Mar 16, 2018
StartActual
Feb 16, 2017
Primary completionActual
May 31, 2017
CompletionActual
May 31, 2017
Last update
Mar 19, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03467659
Lead sponsor
Purdue University
Responsible party
Bruce R. Hamaker (Professor, Purdue University) — Principal investigator
First posted
Mar 16, 2018
Start date
Feb 16, 2017
Primary completion
May 31, 2017
Completion
May 31, 2017
Last update
Mar 19, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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