- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03035981
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
Completed
Conditions
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
Interventional
Enrollment (Actual)
12
Phase
- 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
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 |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: White rice, low amylose
Cooked white rice with low amylose content
|
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
|
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
|
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
|
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
|
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
|
White and brown rice were tested for differences in gastric emptying rate and appetitive response
|
|
EXPERIMENTAL: Fructooligosaccharide (FOS)
Fermentable carbohydrate solution
|
White and brown rice were tested for differences in gastric emptying rate and appetitive response
|
What is the study measuring?
Primary Outcome Measures
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
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
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
August 1, 2014
Primary Completion (ACTUAL)
December 1, 2014
Study Completion (ACTUAL)
December 1, 2014
Study Registration Dates
First Submitted
January 26, 2017
First Submitted That Met QC Criteria
January 26, 2017
First Posted (ESTIMATE)
January 30, 2017
Study Record Updates
Last Update Posted (ESTIMATE)
January 30, 2017
Last Update Submitted That Met QC Criteria
January 26, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Other Study ID 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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