NCT03035981

Brief Summary

Glycemic carbohydrates are associated with metabolic disturbances, such as type II diabetes, due to rapid digestion of starch into glucose. The specific properties of starch within these foods has been studied for the purpose of slowing their digestion rate and improving related physiological outcomes, such as gastric emptying rate. The current study investigated the relationship among starch digestion, gastric emptying rate and satiety in white and brown rice.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

January 26, 2017

Last Update Submit

January 26, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Gastric emptying

    Breath test was performed using 13C-octanoic acid mixed into test meals

    Acute study, 4 hours after consumption of test food

  • Appetitive response

    Fullness and hunger questionnaire was given at various time points after consumption of test foods

    Acute study, 4 hours after consumption of test food

Secondary Outcomes (1)

  • Breath hydrogen

    Acute study, 4 hours after consumption of test food

Study Arms (7)

White rice, low amylose

EXPERIMENTAL

Cooked white rice with low amylose content

Other: White rice, low amylose

White rice, high amylose

EXPERIMENTAL

Cooked white rice with high amylose content

Other: White rice, high amylose

White rice, slow

EXPERIMENTAL

Cooked white rice with slow digesting starch

Other: White rice, slow

White rice, resistant

EXPERIMENTAL

Cooked white rice with resistant starch

Other: White rice, resistant

Brown rice, low amylose

EXPERIMENTAL

Cooked brown rice with low amylose content

Other: Brown rice, low amylose

Brown rice, high amylose

EXPERIMENTAL

Cooked brown rice with high amylose content

Other: Brown rice, high amylose

Fructooligosaccharide (FOS)

EXPERIMENTAL

Fermentable carbohydrate solution

Other: Fructooligosaccharide (FOS)

Interventions

White and brown rice were tested for differences in gastric emptying rate and appetitive response

White rice, low amylose

White and brown rice were tested for differences in gastric emptying rate and appetitive response

White rice, high amylose

White and brown rice were tested for differences in gastric emptying rate and appetitive response

White rice, slow

White and brown rice were tested for differences in gastric emptying rate and appetitive response

White rice, resistant

White and brown rice were tested for differences in gastric emptying rate and appetitive response

Brown rice, low amylose

White and brown rice were tested for differences in gastric emptying rate and appetitive response

Brown rice, high amylose

White and brown rice were tested for differences in gastric emptying rate and appetitive response

Fructooligosaccharide (FOS)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal body mass index (18 kg/m2 ≤ BMI ≤ 25 kg/m2)

You may not qualify if:

  • Under any medication
  • History of any gastrointestinal disease or surgery
  • Diabetes
  • Smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Appetitive Behavior

Interventions

fructooligosaccharide

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 26, 2017

First Posted

January 30, 2017

Study Start

August 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 30, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share