NCT03467659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

March 10, 2018

Last Update Submit

March 15, 2018

Conditions

ObesityDiabetes Mellitus, Type 2Appetitive Behavior

Outcome Measures

Primary Outcomes (3)

  • Gastric emptying

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

    Acute study, 4 hours measurement after consumption of test food

  • Glycemic response

    Blood glucose was measured using a continuous glucose monitor

    Acute study, 4 hours measurement after consumption of test food

  • 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.

Study Arms (6)

Cracked whole wheat porridge

EXPERIMENTAL

Large particle whole wheat porridge

Other: Cracked whole wheat porridge

Semolina wheat porridge

EXPERIMENTAL

Large particle refined wheat porridge

Other: Semolina wheat porridge

Whole wheat flour porridge

EXPERIMENTAL

Small particle whole wheat porridge

Other: Whole wheat flour porridge

Refined wheat flour porridge

EXPERIMENTAL

Small particle refined wheat porridge

Other: Refined wheat flour porridge

Refined wheat flour porridge,fine bran

EXPERIMENTAL

Small particle refined wheat porridge with small particle bran

Other: Refined wheat flour porridge,fine bran

Refined wheat flour porridge,coarse bran

EXPERIMENTAL

Small particle refined wheat porridge with large particle bran

Other: Refined wheat flour porridge,coarse bran

Interventions

Cracked whole wheat porridgeOTHER

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

Cracked whole wheat porridge
Semolina wheat porridgeOTHER

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

Semolina wheat porridge
Whole wheat flour porridgeOTHER

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

Whole wheat flour porridge
Refined wheat flour porridgeOTHER

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

Refined wheat flour porridge
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,fine bran
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.

Refined wheat flour porridge,coarse bran

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • No medical problems
  • No medication
  • Pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (6)

  • 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.

    PMID: 9097998BACKGROUND

  • 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.

    PMID: 20443742BACKGROUND

  • 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.

    PMID: 23777402BACKGROUND

  • 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.

    PMID: 8500721BACKGROUND

  • 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.

    PMID: 6776794BACKGROUND

  • 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.

    PMID: 34999739DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Appetitive Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBehavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2018

First Posted

March 16, 2018

Study Start

February 16, 2017

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

March 19, 2018

Record last verified: 2018-03

Locations

US(1)