Gastric Emptying of Rice With Different Starch Properties

January 26, 2017 updated by: Bruce R. Hamaker, Purdue University

Assessment of Gastric Emptying and Fullness of Rice With Different Starch Properties

Glycemic carbohydrates are associated with metabolic disturbances, such as type II diabetes, due to rapid digestion of starch into glucose. The specific properties of starch within these foods has been studied for the purpose of slowing their digestion rate and improving related physiological outcomes, such as gastric emptying rate. The current study investigated the relationship among starch digestion, gastric emptying rate and satiety in white and brown rice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Studies have indicated that starch-based foods with somewhat high amylose content have slower in vitro starch digestion rates, which relate to a low glycemic response. Low glycemic response is associated with delayed gastric emptying rate as well. Therefore, we hypothesized that rice with a slow starch digesting property would delay gastric emptying. White and brown rice with varying amylose contents were used in this study. A 13C-labeled octanoic acid breath test method was used to measure gastric emptying rate, and questionnaires were used to assess hunger and fullness during the testing sessions. Twelve healthy volunteers were recruited to participate in a crossover design study with six rice treatments and outcome measurements were gastric emptying and satiety assessments. One fermentable carbohydrate (fructooligosaccharide, FOS) solution was used to validate the production of breath hydrogen.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal body mass index (18 kg/m2 ≤ BMI ≤ 25 kg/m2)

Exclusion Criteria:

  • Under any medication
  • History of any gastrointestinal disease or surgery
  • Diabetes
  • Smoker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: White rice, low amylose
Cooked white rice with low amylose content
Other: White rice, low amylose
White and brown rice were tested for differences in gastric emptying rate and appetitive response
EXPERIMENTAL: White rice, high amylose
Cooked white rice with high amylose content
Other: White rice, high amylose
White and brown rice were tested for differences in gastric emptying rate and appetitive response
EXPERIMENTAL: White rice, slow
Cooked white rice with slow digesting starch
Other: White rice, slow
White and brown rice were tested for differences in gastric emptying rate and appetitive response
EXPERIMENTAL: White rice, resistant
Cooked white rice with resistant starch
Other: White rice, resistant
White and brown rice were tested for differences in gastric emptying rate and appetitive response
EXPERIMENTAL: Brown rice, low amylose
Cooked brown rice with low amylose content
Other: Brown rice, low amylose
White and brown rice were tested for differences in gastric emptying rate and appetitive response
EXPERIMENTAL: Brown rice, high amylose
Cooked brown rice with high amylose content
Other: Brown rice, high amylose
White and brown rice were tested for differences in gastric emptying rate and appetitive response
EXPERIMENTAL: Fructooligosaccharide (FOS)
Fermentable carbohydrate solution
Other: Fructooligosaccharide (FOS)
White and brown rice were tested for differences in gastric emptying rate and appetitive response

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gastric emptying
Time Frame: Acute study, 4 hours after consumption of test food
Breath test was performed using 13C-octanoic acid mixed into test meals
Acute study, 4 hours after consumption of test food
Appetitive response
Time Frame: Acute study, 4 hours after consumption of test food
Fullness and hunger questionnaire was given at various time points after consumption of test foods
Acute study, 4 hours after consumption of test food

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Breath hydrogen
Time Frame: Acute study, 4 hours after consumption of test food
Hydrogen breath test was performed following ingestion of test meals
Acute study, 4 hours after consumption of test food

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Purdue University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1405014904

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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