- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03254082
Glycemic Response of Sorghum
August 15, 2017 updated by: Mark D. Haub, Kansas State University
Glycemic Response of Cooked Grains Including Sorghum
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Gruel was formed via a 1:9 ratio of grain (30 g) to water (270 ml) and cooked until thickened by placing water and grain mixture in a beaker and placed in a hot water bath (cooked over a stove/heating unit).
The gruel was allowed to cool for 3-5 minutes before eating.
The consistency of the gruel was similar to oatmeal.
Subjects had a resting blood sample collected for assessment of fasting blood glucose, then ate the gruel (or control sucrose, 22g) that was assigned for that day -- they returned for the other gruel meals or sucrose control determined by Latin Square randomization.
Finger stick blood samples where then collected at 30, 60, 90, and 120 minutes after eating the gruel (or sucrose) began.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Apparently healthy with no known diseases
Exclusion Criteria:
- Known metabolic, cancer, cardiovascular disease/condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: F-1000 (fontanelle flour)
Fontenel sorghum flour
|
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.
Other Names:
|
|
Experimental: Sumac
Sumac sorghum 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.
|
|
Experimental: Wheat
Wheat flour
|
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.
|
|
Experimental: MMR
MMR cultivar of sorghum flour -- from MMR Genetics, a company that produces sorghum seed.
|
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.
|
|
Active Comparator: Sucrose
Table sugar
|
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)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood glucose
Time Frame: 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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Haub, PhD, Kansas State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
September 2, 2015
First Submitted That Met QC Criteria
August 15, 2017
First Posted (Actual)
August 18, 2017
Study Record Updates
Last Update Posted (Actual)
August 18, 2017
Last Update Submitted That Met QC Criteria
August 15, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KSUHML10_Sorg
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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