Glycemic Response to High Amylose Rice
2 other identifiers
interventional
18
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2012
CompletedFirst Posted
Study publicly available on registry
September 14, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedSeptember 1, 2014
August 1, 2014
1 year
September 11, 2012
August 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Glucose response
Evaluated changes in blood glucose after consuming a bolus of carbohydrate from rice or a standard glucose beverage.
120 minutes
Secondary Outcomes (2)
Insulin Response
120 minutes
Appetite Response
120 minutes
Study Arms (4)
High Amylose Rice 1
EXPERIMENTALTest rice with high dietary fiber content
High Amylose Rice 2
EXPERIMENTALTest rice with high dietary fiber content
Control Rice
PLACEBO COMPARATORRice portion that contains 50 g carbohydrate.
Glucose beverage
PLACEBO COMPARATORGlucose beverage with 50 g carbohydrate
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Hawaii at Manoa
Honolulu, Hawaii, 96822, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Stewart, PhD
University of Hawaii at Manoa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 11, 2012
First Posted
September 14, 2012
Study Start
October 1, 2012
Primary Completion
October 1, 2013
Study Completion
January 1, 2014
Last Updated
September 1, 2014
Record last verified: 2014-08