NCT03254082

Brief Summary

Given the interest in gluten-free foods and discovering dietary means to prevent metabolic disorders, this study was designed to determine the glycemic responses of four (4) grains and flours (corn, rice, wheat, and sorghum). The grain products (gruel) will be eaten by subjects and blood glucose will be collected prior to and after eating over the course of two hours. A dextrose solution, dosed to provide a like amount of available carbohydrate, will serve as the control treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2015

Completed
2 years until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

8 months

First QC Date

September 2, 2015

Last Update Submit

August 15, 2017

Conditions

Keywords

sorghum health

Outcome Measures

Primary Outcomes (1)

  • Blood glucose

    This is an acute (over 2 hours) trial to measure blood glucose (glycemic response) to food.

    Before eating (time 0) and 30, 60, 90, and 120 minutes after eating to measure the change in blood glucose due to the different food.

Study Arms (5)

F-1000 (fontanelle flour)

EXPERIMENTAL

Fontenel sorghum flour

Other: Glycemic response of F-1000

Sumac

EXPERIMENTAL

Sumac sorghum flour

Other: Glycemic response to sumac sorghum flour

Wheat

EXPERIMENTAL

Wheat flour

Other: Glycemic response to wheat flour

MMR

EXPERIMENTAL

MMR cultivar of sorghum flour -- from MMR Genetics, a company that produces sorghum seed.

Other: Glycemic response to MMR sorghum flour

Sucrose

ACTIVE COMPARATOR

Table sugar

Other: Glycemic response to sucrose

Interventions

The intervention was to determine if different flours elicit similar or different (change from baseline) 2 hour glucose responses (e.g., similar to glycemic index) after eating.

Also known as: Fontanelle flour
F-1000 (fontanelle flour)

The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming sumac sorghum flour as a gruel.

Sumac

The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming MMR sorghum flour as a gruel.

MMR

The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming wheat flour as a gruel.

Wheat

The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming sugar (dissolved in water)

Also known as: sugar
Sucrose

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Apparently healthy with no known diseases

You may not qualify if:

  • Known metabolic, cancer, cardiovascular disease/condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sugars

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Mark Haub, PhD

    Kansas State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 2, 2015

First Posted

August 18, 2017

Study Start

September 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

August 18, 2017

Record last verified: 2017-08