Satiety Response of White and Brown Rice Compared to Gluc... | NCT01508975

Studies
Satiety Response of White and Brown Rice Compared to Glucose Control

NCT01508975

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Nov 1, 2019Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Food Selection

Interventions

White Rice, Brown Rice, Glucose

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jan 9, 2012

First Submission Date that Met QC Criteria

Jan 11, 2012

First Posted Date

Jan 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2019

Last Update Posted Date

Nov 1, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators hypothesize that consumption of either white or brown rice will be more satiating than glucose control.

Detailed Description

This study is an acute, randomized, repeated measures design with 20 subjects. Subjects will consume 3 test breakfasts, white rice, brown rice, or glucose control, each containing 400 calories. Treatments will be one week apart. After consumption of the controlled breakfast, subjects will complete visual analogue scales (VAS) for satiety response. Additionally, they will consume a pizza lunch and record food intake for the next 24 hours. Breath gas samples will be collected to estimate fermentation of fiber in the large intestine. Also, subjective data on gastrointestinal tolerance will be collected.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
white rice	Experimental	White rice	Other: White Rice, Brown Rice, Glucose
Brown rice	Experimental	Brown Rice	Other: White Rice, Brown Rice, Glucose
Glucose	Experimental	Glucose	Other: White Rice, Brown Rice, Glucose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
White Rice, Brown Rice, Glucose	Other	white rice, brown rice, glucose	Brown rice Glucose white rice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Satiety	Visual analogue scales (subjective measurements)	4 hours following breakfast

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy subjects

Exclusion Criteria:

inability to consume rice for breakfast

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joanne Slavin, PhD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Food Science and Nutrition		Saint Paul	Minnesota	55108	United States

Condition Browse Module

MeSH Terms

ID	Term
D005518	Food Preferences
D009765	Obesity

Ancestor Terms

ID	Term
D005247	Feeding Behavior
D001519	Behavior
D050177	Overweight
D044343	Overnutrition

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005947	Glucose

Ancestor Terms

ID	Term
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided