Appetitive BehaviorNCT03035981
Gastric Emptying of Rice With Different Starch Properties
A study testing White rice, low amylose, White rice, high amylose and White rice, slow in people with Appetitive Behavior, run by Purdue University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- What is being tested?
- White rice, low amylose, White rice, high amylose and White rice, slow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Dec 2014
- 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
- Normal body mass index (18 kg/m2 ≤ BMI ≤ 25 kg/m2)
Who cannot join
- Under any medication
- History of any gastrointestinal disease or surgery
- Diabetes
- Smoker
About this study
Official title: 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.
Read the 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.
- Conditions
- Appetitive Behavior
- Being tested
- White rice, low amylose, White rice, high amylose, White rice, slow, White rice, resistant, Brown rice, low amylose
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White rice, low amyloseOther
White and brown rice were tested for differences in gastric emptying rate and appetitive response
White rice, high amyloseOther
White and brown rice were tested for differences in gastric emptying rate and appetitive response
White rice, slowOther
White and brown rice were tested for differences in gastric emptying rate and appetitive response
White rice, resistantOther
White and brown rice were tested for differences in gastric emptying rate and appetitive response
Brown rice, low amyloseOther
White and brown rice were tested for differences in gastric emptying rate and appetitive response
Brown rice, high amyloseOther
White and brown rice were tested for differences in gastric emptying rate and appetitive response
Fructooligosaccharide (FOS)Other
White and brown rice were tested for differences in gastric emptying rate and appetitive response
| Study group | Role | What they receive |
|---|---|---|
| White rice, low amylose | Experimental | Cooked white rice with low amylose content Receives: Other: White rice, low amylose |
| White rice, high amylose | Experimental | Cooked white rice with high amylose content Receives: Other: White rice, high amylose |
| White rice, slow | Experimental | Cooked white rice with slow digesting starch Receives: Other: White rice, slow |
| White rice, resistant | Experimental | Cooked white rice with resistant starch Receives: Other: White rice, resistant |
| Brown rice, low amylose | Experimental | Cooked brown rice with low amylose content Receives: Other: Brown rice, low amylose |
| Brown rice, high amylose | Experimental | Cooked brown rice with high amylose content Receives: Other: Brown rice, high amylose |
| Fructooligosaccharide (FOS) | Experimental | Fermentable carbohydrate solution Receives: Other: Fructooligosaccharide (FOS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying
Breath test was performed using 13C-octanoic acid mixed into test meals
Measured: Acute study, 4 hours after consumption of test food
Appetitive response
Fullness and hunger questionnaire was given at various time points after consumption of test foods
Measured: Acute study, 4 hours after consumption of test food
Secondary outcomes (1)
Breath hydrogen
Hydrogen breath test was performed following ingestion of test meals
Measured: Acute study, 4 hours 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.
- First posted30 Jan 2017 (estimated)
- Study startAug 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce R. Hamaker, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035981
- Sponsor's protocol ID
- 1405014904
- Status last verified
- Jan 2017
- First submitted
- 26 Jan 2017
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Gastric Emptying and Fullness of Rice With Different Starch Properties
- ClinicalTrials.gov ID
- NCT03035981
- Acronym / sponsor ID
- 1405014904
- Conditions
- Appetitive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| White rice, low amylose | Experimental | Other: White rice, low amyloseCooked white rice with low amylose content |
| White rice, high amylose | Experimental | Other: White rice, high amyloseCooked white rice with high amylose content |
| White rice, slow | Experimental | Other: White rice, slowCooked white rice with slow digesting starch |
| White rice, resistant | Experimental | Other: White rice, resistantCooked white rice with resistant starch |
| Brown rice, low amylose | Experimental | Other: Brown rice, low amyloseCooked brown rice with low amylose content |
| Brown rice, high amylose | Experimental | Other: Brown rice, high amyloseCooked brown rice with high amylose content |
| Fructooligosaccharide (FOS) | Experimental | Other: Fructooligosaccharide (FOS)Fermentable carbohydrate solution |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal body mass index (18 kg/m2 ≤ BMI ≤ 25 kg/m2)
Key exclusion criteria (4 listed)
- Under any medication
- History of any gastrointestinal disease or surgery
- Diabetes
- Smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White rice, low amyloseWhite and brown rice were tested for differences in gastric emptying rate and appetitive response | Other | White rice, low amylose |
| White rice, high amyloseWhite and brown rice were tested for differences in gastric emptying rate and appetitive response | Other | White rice, high amylose |
| White rice, slowWhite and brown rice were tested for differences in gastric emptying rate and appetitive response | Other | White rice, slow |
| White rice, resistantWhite and brown rice were tested for differences in gastric emptying rate and appetitive response | Other | White rice, resistant |
| Brown rice, low amyloseWhite and brown rice were tested for differences in gastric emptying rate and appetitive response | Other | Brown rice, low amylose |
| Brown rice, high amyloseWhite and brown rice were tested for differences in gastric emptying rate and appetitive response | Other | Brown rice, high amylose |
| Fructooligosaccharide (FOS)White and brown rice were tested for differences in gastric emptying rate and appetitive response | Other | Fructooligosaccharide (FOS) |
Primary outcome
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
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
1 secondary outcome
Breath hydrogen
Time frame: Acute study, 4 hours after consumption of test food
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing White rice, low amylose, White rice, high amylose and White rice, slow in people with Appetitive Behavior, run by Purdue University.
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 1 inclusion and 4 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 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 after consumption of test food). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2017.