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ObesityNCT03467659

Whole Grains, Gastric Emptying and Glycemic Response

A study testing Cracked whole wheat porridge, Semolina wheat porridge and Whole wheat flour porridge in people with Obesity and Diabetes Mellitus, Type 2, run by Purdue University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
Cracked whole wheat porridge, Semolina wheat porridge and Whole wheat flour porridge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
16 Feb 2017to 31 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • No medical problems
  • No medication
  • Pregnant or nursing

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Purdue University

    West Lafayette, Indiana, 47907

Other trials in United States

About this study

Official title: 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.

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.

Being tested
Cracked whole wheat porridge, Semolina wheat porridge, Whole wheat flour porridge, Refined wheat flour porridge, Refined wheat flour porridge,fine bran
Medical subject headings
Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cracked whole wheat porridgeOther

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

  • Semolina wheat porridgeOther

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

  • Whole wheat flour porridgeOther

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

  • Refined wheat flour porridgeOther

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

  • Refined wheat flour porridge,fine branOther

    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 branOther

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

Study groups in NCT03467659
Study groupRoleWhat they receive
Cracked whole wheat porridgeExperimentalLarge particle whole wheat porridge
Receives: Other: Cracked whole wheat porridge
Semolina wheat porridgeExperimentalLarge particle refined wheat porridge
Receives: Other: Semolina wheat porridge
Whole wheat flour porridgeExperimentalSmall particle whole wheat porridge
Receives: Other: Whole wheat flour porridge
Refined wheat flour porridgeExperimentalSmall particle refined wheat porridge
Receives: Other: Refined wheat flour porridge
Refined wheat flour porridge,fine branExperimentalSmall particle refined wheat porridge with small particle bran
Receives: Other: Refined wheat flour porridge,fine bran
Refined wheat flour porridge,coarse branExperimentalSmall particle refined wheat porridge with large particle bran
Receives: Other: Refined wheat flour porridge,coarse bran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gastric emptying

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

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

  2. Glycemic response

    Blood glucose was measured using a continuous glucose monitor

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2018
  2. Study start16 Feb 2017
  3. Primary completion31 May 2017
  4. Study completion31 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03467659
Sponsor's protocol ID
1611018484
Status last verified
Mar 2018
First submitted
10 Mar 2018
Last updated
19 Mar 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Cracked whole wheat porridge, Semolina wheat porridge and Whole wheat flour porridge in people with Obesity and Diabetes Mellitus, Type 2, run by Purdue University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gastric emptying (time frame: Acute study, 4 hours measurement after consumption of test food). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03467659, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018.

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