Glycemic Response to High Amylose Rice
Condition: Diabetes Treatment (Pilot Study)
Study type: Interventional

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. 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.
    

Intervention name(s): Rice; Rice; Rice; Glucose Beverage
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Rice portion containing 50 g total carbohydrate; Rice portion that provides 50 g total carbohydrate.; Rice portion that provides 50 g total carbohydrate.; Glucose beverage that provides 50 g total carbohydrate.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: postprandial glycemic response; postprandial insulin response; rice; appetite; hunger