Blood GlucoseNCT03254082
Glycemic Response of Sorghum
A study testing Glycemic response of F-1000, Glycemic response to sumac sorghum flour and Glycemic response to MMR sorghum flour in people with Blood Glucose, run by Kansas State University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose
- What is being tested?
- Glycemic response of F-1000, Glycemic response to sumac sorghum flour and Glycemic response to MMR sorghum flour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy with no known diseases
Who cannot join
- Known metabolic, cancer, cardiovascular disease/condition
About this study
Official title: 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.
Read the 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.
- Conditions
- Blood Glucose
- Being tested
- Glycemic response of F-1000, Glycemic response to sumac sorghum flour, Glycemic response to MMR sorghum flour, Glycemic response to wheat flour, Glycemic response to sucrose
- Keywords
- sorghum health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycemic response of F-1000Other
Also called Fontanelle 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.
Glycemic response to sumac sorghum flourOther
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.
Glycemic response to MMR sorghum flourOther
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.
Glycemic response to wheat flourOther
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.
Glycemic response to sucroseOther
Also called 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)
| Study group | Role | What they receive |
|---|---|---|
| F-1000 (fontanelle flour) | Experimental | Fontenel sorghum flour Receives: Other: Glycemic response of F-1000 |
| Sumac | Experimental | Sumac sorghum flour Receives: Other: Glycemic response to sumac sorghum flour |
| Wheat | Experimental | Wheat flour Receives: Other: Glycemic response to wheat flour |
| MMR | Experimental | MMR cultivar of sorghum flour -- from MMR Genetics, a company that produces sorghum seed. Receives: Other: Glycemic response to MMR sorghum flour |
| Sucrose | Active comparator | Table sugar Receives: Other: Glycemic response to sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
This is an acute (over 2 hours) trial to measure blood glucose (glycemic response) to food.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study startSep 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Collaborators
- United Sorghum Checkoff Program
- Responsible party
- Principal investigator, Mark D. Haub, Kansas State University
- Investigators
- Mark Haub, PhD, Principal investigator, Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254082
- Sponsor's protocol ID
- KSUHML10_Sorg
- Status last verified
- Aug 2017
- First submitted
- 2 Sep 2015
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Response of Cooked Grains Including Sorghum
- ClinicalTrials.gov ID
- NCT03254082
- Acronym / sponsor ID
- KSUHML10_Sorg
- Conditions
- Blood Glucose
- Keywords
- sorghum health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Collaborators
- United Sorghum Checkoff Program
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| F-1000 (fontanelle flour) | Experimental | Other: Glycemic response of F-1000Fontenel sorghum flour |
| Sumac | Experimental | Other: Glycemic response to sumac sorghum flourSumac sorghum flour |
| Wheat | Experimental | Other: Glycemic response to wheat flourWheat flour |
| MMR | Experimental | Other: Glycemic response to MMR sorghum flourMMR cultivar of sorghum flour -- from MMR Genetics, a company that produces sorghum seed. |
| Sucrose | Active comparator | Other: Glycemic response to sucroseTable sugar |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Apparently healthy with no known diseases
Key exclusion criteria (1 listed)
- Known metabolic, cancer, cardiovascular disease/condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycemic response of F-1000Also: Fontanelle flourThe 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 | F-1000 (fontanelle flour) |
| Glycemic response to sumac sorghum flourThe 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. | Other | Sumac |
| Glycemic response to MMR sorghum flourThe 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. | Other | MMR |
| Glycemic response to wheat flourThe 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. | Other | Wheat |
| Glycemic response to sucroseAlso: sugarThe 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 | Sucrose |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Haub, PhD principal investigator
Kansas State University
Questions about this trial
What is this clinical trial studying?
A study testing Glycemic response of F-1000, Glycemic response to sumac sorghum flour and Glycemic response to MMR sorghum flour in people with Blood Glucose, run by Kansas State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.