NCT01685879

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2012

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

Enrollment Period

1 year

First QC Date

September 11, 2012

Last Update Submit

August 28, 2014

Conditions

Keywords

postprandial glycemic responsepostprandial insulin responsericeappetitehunger

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

EXPERIMENTAL

Test rice with high dietary fiber content

Other: Rice

High Amylose Rice 2

EXPERIMENTAL

Test rice with high dietary fiber content

Other: Rice

Control Rice

PLACEBO COMPARATOR

Rice portion that contains 50 g carbohydrate.

Other: Rice

Glucose beverage

PLACEBO COMPARATOR

Glucose beverage with 50 g carbohydrate

Other: Glucose Beverage

Interventions

RiceOTHER

Rice portion containing 50 g total carbohydrate

High Amylose Rice 1

Glucose beverage that provides 50 g total carbohydrate.

Glucose beverage

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

Study Officials

  • Maria Stewart, PhD

    University of Hawaii at Manoa

    PRINCIPAL INVESTIGATOR

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

Locations