Completed

Glycemic Response to High Amylose Rice

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What is being tested

Rice

+ Rice

+ Rice

Other
Who is being recruted

From 18 to 40 Years
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-Controlled
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorUniversity of Hawaii
Last updated: September 1, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01685879
Principal SponsorUniversity of Hawaii
Last updated: September 1, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

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

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Test rice with high dietary fiber content

Group II

Experimental
Test rice with high dietary fiber content

Group III

Placebo
Rice portion that contains 50 g carbohydrate.

Group IV

Placebo
Glucose beverage with 50 g carbohydrate

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Hawaii at Manoa

Honolulu, United StatesOpen University of Hawaii at Manoa in Google Maps
CompletedOne Study Center