Diabetes Treatment (Pilot Study)NCT01685879
Glycemic Response to High Amylose Rice
A study testing Rice and Glucose Beverage in people with Diabetes Treatment (Pilot Study), run by University of Hawaii at 1 site in United States.
Trial summary
Certain types of rice have more dietary fiber than others. This type of rice is known a "high amylose rice." This study hypothesizes that high-amylose rice, will decrease blood glucose and insulin responses after consumption compared to conventional rice in healthy adults, ages 18-40. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Treatment (Pilot Study)
- What is being tested?
- Rice and Glucose Beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jan 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gender: male or female
- Age 18-40 years old
- In good general health
- Habitual breakfast eater
- Able to fast for 12 hours
- Available 7:00am-9:30am on weekdays
- Willing to participate in study and complete 4 study visits within a 6-week period
- Capable of giving informed consent
Who cannot join
- Current smoker
- BMI > 30 kg/m2
- Current use of medications that alter appetite (antidepressants, antibiotics, weight loss medications, or appetite suppressants)
- Current use of medications to control blood glucose, insulin or insulin receptors
- History of pre-diabetes, diabetes, hyperglycemia, hyperinsulinemia, gastrointestinal disease or surgery, or eating disorders
- Food allergy of any kind
Show all 11Show fewer
- Vegetarian
- For females, pregnancy (current or within past 6 months) or lack of a regular menstrual cycle.
- History of bleeding or clotting disorders (e.g. hemophilia, thrombocytopenia, Vitamin K deficiency, liver failure)
- Current use of medications or supplements that may interfere with clotting and prolong bleeding time (e.g. aspirin, NSAIDS, coumadin, other anticoagulant therapy, herbal supplements including, but not limited to curcumin and flavonoids)
- Problems with vascular access or difficulty tolerating blood draws
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hawaii at Manoa
Honolulu, Hawaii, 96822
About this study
Certain types of rice have more dietary fiber than others. This type of rice is known a "high amylose rice." This study hypothesizes that high-amylose rice, will decrease blood glucose and insulin responses after consumption compared to conventional rice in healthy adults, ages 18-40. Eighteen healthy men and women will participate in this study. This study will determine how high blood glucose and insulin values rise after eating a portion of rice. This study will also evaluate hunger ratings after consuming rice. The results of this study will help researchers better understand how diet can influence diabetes management.
Read the detailed description
This is a pilot study to assess glucose response in humans to a rice sample prepared with high amylose rice (high amylose rice 1 and high amylose rice 2), compared to conventional rice and a glucose test beverage.
Study Design: The proposed study is a randomized single-blind crossover design with repeated measures using human subjects (clinical study).
Treatment: The amount of resistant starch, a type of dietary fiber, is greater for high amylose varieties of rice than conventional varieties of rice. High amylose rice is commercially produced in Louisiana and Arkansas, USA. This specific rice has been bred to contain more amylose than ordinary (conventional) rice. This food is not genetically modified.
Brief Methods: Study subjects (men and women) aged 18-40 years old will be recruited from the UH-Manoa campus and Honolulu area via flyers. Interested individuals will be screened by telephone for initial eligibility (nonsmoker, non-vegetarian, habitual breakfast eater, able to fast for 12 hours, available 7:00am-10:00 am on weekdays, willing to participate in study). Based on the initial phone screening, eligible study subjects will attend an enrollment visit to complete the consent form, obtain study materials, and confirm health status and eligibility based on subject inclusion and exclusion criteria. Individuals who do not meet study eligibility will have all records destroyed. 18 healthy subjects (9 men and 9 women) will attend 4 morning study visits at the RMATRIX CRC at The Queens Medical Center. Subjects will complete a 24-hour food record for the 24 hours prior to the study visit. Subjects will be fasted for 12 hours at the time of the study visit. Upon arrival, subjects will have an IV inserted for serial blood draws, fasting blood samples will be obtained (time = 0). Subjects will then be presented one of four treatments in random order: high amylose rice-1, high amylose rice-2, conventional rice or glucose beverage. Subjects will be instructed to consume the sample or beverage within 15 minutes. Blood samples will be taken at 15, 30, 45, 60, 90, and 120 minutes. Subjects will complete an appetite survey after each blood draw. Upon completion of the study visit, subjects will be offered a snack and juice and monitored for safety.
Study staff: A graduate research assistant in the Nutrition graduate program will coordinate the clinical study. Undergraduate research assistants will assist with study visits. All students will be working under Dr. Stewart's supervision. All study staff will complete UHM biosafety training, UMH blood borne pathogens training, and UMH or NIH human subjects training.
Clinical Support: The study will be supported by nursing staff from the RMATRIX PCR to perform IV catheter insertion, collect serial blood samples and monitor for adverse events.
- Conditions
- Diabetes Treatment (Pilot Study)
- Being tested
- Rice, Glucose Beverage
- Keywords
- postprandial glycemic response, postprandial insulin response, rice, appetite, hunger
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiceOther
Rice portion containing 50 g total carbohydrate
RiceOther
Rice portion that provides 50 g total carbohydrate.
RiceOther
Rice portion that provides 50 g total carbohydrate.
Glucose BeverageOther
Glucose beverage that provides 50 g total carbohydrate.
| Study group | Role | What they receive |
|---|---|---|
| High Amylose Rice 1 | Experimental | Test rice with high dietary fiber content Receives: Other: Rice |
| High Amylose Rice 2 | Experimental | Test rice with high dietary fiber content Receives: Other: Rice |
| Control Rice | Placebo comparator | Rice portion that contains 50 g carbohydrate. Receives: Other: Rice |
| Glucose beverage | Placebo comparator | Glucose beverage with 50 g carbohydrate Receives: Other: Glucose Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose response
Evaluated changes in blood glucose after consuming a bolus of carbohydrate from rice or a standard glucose beverage.
Measured: 120 minutes
Secondary outcomes (2)
Insulin Response
Measure insulin concentrations after consuming a bolus of carbohydrate from rice or standard glucose beverage.
Measured: 120 minutes
Appetite Response
Measure appetite after consuming a bolus of carbohydrate from rice or standard glucose beverage.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Treatment (Pilot Study)Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Stewart, University of Hawaii
- Investigators
- Maria Stewart, PhD, Principal investigator, University of Hawaii at Manoa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685879
- Sponsor's protocol ID
- HARice
- Other IDs
- Project HAW00262H
- Status last verified
- Aug 2014
- First submitted
- 11 Sep 2012
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Response to High Amylose Rice
- ClinicalTrials.gov ID
- NCT01685879
- Acronym / sponsor ID
- HARice
- Conditions
- Diabetes Treatment (Pilot Study)
- Keywords
- postprandial glycemic response, postprandial insulin response, rice, appetite, hunger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Sep 2012 (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.
Certain types of rice have more dietary fiber than others. This type of rice is known a "high amylose rice." This study hypothesizes that high-amylose rice, will decrease blood glucose and insulin responses after consumption compared to conventional rice in healthy adults, ages 18-40. Eighteen healthy men and women will participate in this study. This study will determine how high blood glucose and insulin values rise after eating a portion of rice. This study will also evaluate hunger ratings after consuming rice. The results of this study will help researchers better understand how diet can influence diabetes management.
Detailed description
This is a pilot study to assess glucose response in humans to a rice sample prepared with high amylose rice (high amylose rice 1 and high amylose rice 2), compared to conventional rice and a glucose test beverage.
Study Design: The proposed study is a randomized single-blind crossover design with repeated measures using human subjects (clinical study).
Treatment: The amount of resistant starch, a type of dietary fiber, is greater for high amylose varieties of rice than conventional varieties of rice. High amylose rice is commercially produced in Louisiana and Arkansas, USA. This specific rice has been bred to contain more amylose than ordinary (conventional) rice. This food is not genetically modified.
Brief Methods: Study subjects (men and women) aged 18-40 years old will be recruited from the UH-Manoa campus and Honolulu area via flyers. Interested individuals will be screened by telephone for initial eligibility (nonsmoker, non-vegetarian, habitual breakfast eater, able to fast for 12 hours, available 7:00am-10:00 am on weekdays, willing to participate in study). Based on the initial phone screening, eligible study subjects will attend an enrollment visit to complete the consent form, obtain study materials, and confirm health status and eligibility based on subject inclusion and exclusion criteria. Individuals who do not meet study eligibility will have all records destroyed. 18 healthy subjects (9 men and 9 women) will attend 4 morning study visits at the RMATRIX CRC at The Queens Medical Center. Subjects will complete a 24-hour food record for the 24 hours prior to the study visit. Subjects will be fasted for 12 hours at the time of the study visit. Upon arrival, subjects will have an IV inserted for serial blood draws, fasting blood samples will be obtained (time = 0). Subjects will then be presented one of four treatments in random order: high amylose rice-1, high amylose rice-2, conventional rice or glucose beverage. Subjects will be instructed to consume the sample or beverage within 15 minutes. Blood samples will be taken at 15, 30, 45, 60, 90, and 120 minutes. Subjects will complete an appetite survey after each blood draw. Upon completion of the study visit, subjects will be offered a snack and juice and monitored for safety.
Study staff: A graduate research assistant in the Nutrition graduate program will coordinate the clinical study. Undergraduate research assistants will assist with study visits. All students will be working under Dr. Stewart's supervision. All study staff will complete UHM biosafety training, UMH blood borne pathogens training, and UMH or NIH human subjects training.
Clinical Support: The study will be supported by nursing staff from the RMATRIX PCR to perform IV catheter insertion, collect serial blood samples and monitor for adverse events.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Amylose Rice 1 | Experimental | Other: RiceTest rice with high dietary fiber content |
| High Amylose Rice 2 | Experimental | Other: RiceTest rice with high dietary fiber content |
| Control Rice | Placebo comparator | Other: RiceRice portion that contains 50 g carbohydrate. |
| Glucose beverage | Placebo comparator | Other: Glucose BeverageGlucose beverage with 50 g carbohydrate |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Gender: male or female
Key exclusion criteria (11 listed)
- Current smoker
- BMI > 30 kg/m2
- Current use of medications that alter appetite (antidepressants, antibiotics, weight loss medications, or appetite suppressants)
- Current use of medications to control blood glucose, insulin or insulin receptors
- History of pre-diabetes, diabetes, hyperglycemia, hyperinsulinemia, gastrointestinal disease or surgery, or eating disorders
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 |
|---|---|---|
| RiceRice portion containing 50 g total carbohydrate | Other | High Amylose Rice 1 |
| RiceRice portion that provides 50 g total carbohydrate. | Other | High Amylose Rice 2 |
| RiceRice portion that provides 50 g total carbohydrate. | Other | Control Rice |
| Glucose BeverageGlucose beverage that provides 50 g total carbohydrate. | Other | Glucose beverage |
Primary outcome
Blood Glucose response
Time frame: 120 minutes
Evaluated changes in blood glucose after consuming a bolus of carbohydrate from rice or a standard glucose beverage.
2 secondary outcomes
Insulin Response
Time frame: 120 minutes
Appetite Response
Time frame: 120 minutes
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 1 Sep 2014.
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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.
Maria Stewart, PhD principal investigator
University of Hawaii at Manoa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rice and Glucose Beverage in people with Diabetes Treatment (Pilot Study), run by University of Hawaii 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 8 inclusion and 11 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 1 Sep 2014. 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. Some participants in this study may receive a placebo. 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?
Blood Glucose response (time frame: 120 minutes). 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 1 Sep 2014; AzTrials last refreshed its copy on 4 Nov 2026.