Blood GlucoseNCT03387345
Barley and Rice Mixture Effects on Blood Glucose
A study testing 100% steel cut barley, 100% barley flakes and 50/50 rice-barley mix in people with Blood Glucose and Dietary Fiber, run by Arizona State University at 1 site in United States.
Trial summary
The purpose of this research was to investigate 5 different formulations of whole grain barley and refined white rice against a control of white bread on post-prandial glycemic response, as well as self-reported hunger/satiety in a randomized cross-over trial. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, Dietary Fiber, Hunger
- What is being tested?
- 100% steel cut barley, 100% barley flakes and 50/50 rice-barley mix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2017to 18 Sep 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, English speaking adults;
- BMI between 18 and 30 kg/m2
Who cannot join
- History of GI malabsorption diseases, food allergy or intolerance to gluten;
- Prediabetes, and/or diabetes, and/or treatment with diabetic medications for any reason;
- Hypertension, hypothyroidism and other chronic disease that affects nutrient metabolism;
- Any women pregnant or lactating, or expecting to become pregnant during the study;
- Individuals with a history of bleeding disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Biomedical Collaborative
Phoenix, Arizona, 85004
About this study
Official title: β-glucan Rich Barley and Rice Mixes and Post-prandial Glycemia - a Dose Response Study
The purpose of this research was to investigate 5 different formulations of whole grain barley and refined white rice against a control of white bread on post-prandial glycemic response, as well as self-reported hunger/satiety in a randomized cross-over trial.
Read the detailed description
Beta-glucan-rich barley has been shown to improve glycemic response, reduce hunger and increase satiety. Nutrient-dense grain mixtures that include a new cultivar of barley (Sustagrain, Ardent Mills, LLC) with exceptionally high dietary fiber content may help individuals meet their dietary fiber needs while minimizing the rapid increase in blood glucose following the consumption of a refined grain product. The primary objective of this study was to compare the effects of five different test meals containing varying amounts of whole-grain barley and refined white rice to white bread on post-prandial blood glucose concentrations. A secondary aim was to evaluate changes in self-reported hunger and satiety following the consumption of each treatment. This study was a single-site, blinded, randomized crossover trial among 24 healthy adults. Each participant consumed the following treatments: 100% Sustagrain barley flakes, 100% Sustagrain steel cut barley , an 80/20 rice-steel cut Sustagrain barley mix, a 50/50 rice-steel cut Sustagrain barley mix, 100% rice, and white bread.
- Conditions
- Blood Glucose, Dietary Fiber, Hunger
- Being tested
- 100% steel cut barley, 100% barley flakes, 50/50 rice-barley mix, 80/20 rice-barley mix, 100% rice
- Keywords
- glucose, dietary fiber, glycemia, whole grain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% steel cut barleyOther
25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC).
100% barley flakesOther
25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC).
50/50 rice-barley mixOther
25 g of available carbohydrate was delivered to participants via a 50/50 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).
80/20 rice-barley mixOther
25 g of available carbohydrate was delivered to participants via a 80/20 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).
100% riceOther
25 g of available carbohydrate was delivered to participants via Goya medium grain white rice
white breadOther
25 g of available carbohydrate was delivered to participants via Sara Lee Classic White Bread (Bimbo Bakeries USA, Inc.)
| Study group | Role | What they receive |
|---|---|---|
| bread-50/50-steelcut-80/20-flake-rice | Experimental | 25 g of available carbohydrate was delivered to participants via (1) white bread, followed by (2) 50/50 rice-barley mix, followed by (3) 100% steel cut barley, followed by (4) 80/20 rice-barley mix, followed by (5) 100% barley flakes, followed by (6) 100% rice Receives: Other: 100% steel cut barley; Other: 100% barley flakes; Other: 50/50 rice-barley mix; Other: 80/20 rice-barley mix; Other: 100% rice; Other: white bread |
| 50/50-steelcut-80/20-flake-rice-bread | Experimental | 25 g of available carbohydrate was delivered to participants via (1) 50/50 rice-barley mix, followed by (2) 100% steel cut barley, followed by (3) 80/20 rice-barley mix, followed by (4) 100% barley flakes, followed by (5) 100% rice, followed by (6) white bread Receives: Other: 100% steel cut barley; Other: 100% barley flakes; Other: 50/50 rice-barley mix; Other: 80/20 rice-barley mix; Other: 100% rice; Other: white bread |
| steelcut-80/20-flake-rice-bread-50/50 | Experimental | 25 g of available carbohydrate was delivered to participants via (1) 100% steel cut barley, followed by (2) 80/20 rice-barley mix, followed by (3) 100% barley flakes, followed by (4) 100% rice, followed by (5) white bread, followed by (6) 50/50 rice-barley mix Receives: Other: 100% steel cut barley; Other: 100% barley flakes; Other: 50/50 rice-barley mix; Other: 80/20 rice-barley mix; Other: 100% rice; Other: white bread |
| 80/20-flake-rice-bread-50/50-steelcut | Experimental | 25 g of available carbohydrate was delivered to participants via (1) 80/20 rice-barley mix, followed by (2) 100% barley flakes, followed by (3) 100% rice, followed by (4) white bread, followed by (5) 50/50 rice-barley mix, followed by (6) 100% steel cut barley Receives: Other: 100% steel cut barley; Other: 100% barley flakes; Other: 50/50 rice-barley mix; Other: 80/20 rice-barley mix; Other: 100% rice; Other: white bread |
| flake-rice-bread-50/50-steelcut-80/20 | Experimental | 25 g of available carbohydrate was delivered to participants via (1) 100% barley flakes, followed by (2) 100% rice, followed by (3) white bread, followed by (4) 50/50 rice-barley mix, followed by (5) 100% steel cut barley, followed by (6) 80/20 rice-barley mix Receives: Other: 100% steel cut barley; Other: 100% barley flakes; Other: 50/50 rice-barley mix; Other: 80/20 rice-barley mix; Other: 100% rice; Other: white bread |
| rice-bread-50/50-steelcut-80/20-flake | Experimental | 25 g of available carbohydrate was delivered to participants via (1) 100% rice, followed by (2) white bread, followed by (3) 50/50 rice-barley mix, followed by (4) 100% steel cut barley, followed by (5) 80/20 rice-barley mix, followed by (6) 100% barley flakes Receives: Other: 100% steel cut barley; Other: 100% barley flakes; Other: 50/50 rice-barley mix; Other: 80/20 rice-barley mix; Other: 100% rice; Other: white bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial glycemia
Incremental area under the curve(iAUC) for plasma glucose concentrations were measured at 0, 15, 30, 45, 60, 90 and 120 min using the trapezoidal method to evaluate the glycemic response to each grain treatment.
Measured: 0 min, 15 min, 30 min, 45min , 60 min, 90 min, 120 min
Secondary outcomes (4)
Self-reported hunger
Visual analog scales were used to evaluate self-reported feelings of hunger using the question "How hungry do you feel?" The scale consisted of a 100-millimeter line with anchors "I am not hungry at all" and "I have never been more hungry" at 0 and 100 millimeters, respectively. Lower numbers represent low feelings of hunger while larger values are characteristic of greater hunger. Hunger was assessed at 0, 15, 30, 60, 90 and 120 minutes to evaluate changes across time for each grain treatment.
Measured: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min
Self-reported satiety
Visual analog scales were used to evaluate self-reported feelings of satiety using the question "How satisfied do you feel?" The scale consisted of a 100-millimeter line with anchors "I am completely empty" and "I cannot eat another bite" at 0 and 100 millimeters, respectively. Lower numbers represent low feelings of satiety while larger values are characteristic of greater satiety. Satiety was assessed at 0, 15, 30, 60, 90 and 120 minutes to evaluate changes across time for each grain treatment.
Measured: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min
Self-reported fullness
Visual analog scales were used to evaluate self-reported feelings of fullness using the question "How full do you feel?" The scale consisted of a 100-millimeter line with anchors "Not at all full" and "Totally full" at 0 and 100 millimeters, respectively. Lower numbers represent low feelings of fullness while larger values are characteristic of greater fullness. Fullness was assessed at 0, 15, 30, 60, 90 and 120 minutes to evaluate changes across time for each grain treatment.
Measured: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min
Self-reported prospective food consumption
Visual analog scales were used to evaluate self-reported feelings toward prospective food consumption using the question "How much do you think you can eat?" The scale consisted of a 100-millimeter line with anchors "Nothing at all" and "A lot" at 0 and 100 millimeters, respectively. Lower numbers represent low ability to eat while larger values are characteristic of greater ability to eat. Prospective food consumption was assessed at 0, 15, 30, 60, 90 and 120 minutes to evaluate changes across time for each grain treatment.
Measured: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start13 Feb 2017
- Primary completion4 Sep 2017
- Study completion18 Sep 2017
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.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Otherwise healthy male and female adults
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Ardent Mills, LLC
- Responsible party
- Principal investigator, Corrie Whisner, Arizona State University
- Investigators
- Corrie M Whisner, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387345
- Sponsor's protocol ID
- STUDY00005413
- Status last verified
- Dec 2017
- First submitted
- 19 Dec 2017
- Last updated
- 2 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- β-glucan Rich Barley and Rice Mixes and Post-prandial Glycemia - a Dose Response Study
- ClinicalTrials.gov ID
- NCT03387345
- Acronym / sponsor ID
- STUDY00005413
- Conditions
- Blood Glucose, Dietary Fiber, Hunger
- Keywords
- glucose, dietary fiber, glycemia, whole grain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Ardent Mills, LLC
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 4 Sep 2017 (actual)
- Study completion
- 18 Sep 2017 (actual)
- First posted
- 2 Jan 2018 (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.
The purpose of this research was to investigate 5 different formulations of whole grain barley and refined white rice against a control of white bread on post-prandial glycemic response, as well as self-reported hunger/satiety in a randomized cross-over trial.
Detailed description
Beta-glucan-rich barley has been shown to improve glycemic response, reduce hunger and increase satiety. Nutrient-dense grain mixtures that include a new cultivar of barley (Sustagrain, Ardent Mills, LLC) with exceptionally high dietary fiber content may help individuals meet their dietary fiber needs while minimizing the rapid increase in blood glucose following the consumption of a refined grain product. The primary objective of this study was to compare the effects of five different test meals containing varying amounts of whole-grain barley and refined white rice to white bread on post-prandial blood glucose concentrations. A secondary aim was to evaluate changes in self-reported hunger and satiety following the consumption of each treatment. This study was a single-site, blinded, randomized crossover trial among 24 healthy adults. Each participant consumed the following treatments: 100% Sustagrain barley flakes, 100% Sustagrain steel cut barley , an 80/20 rice-steel cut Sustagrain barley mix, a 50/50 rice-steel cut Sustagrain barley mix, 100% rice, and white bread.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Otherwise healthy male and female adults
| Arm | Type | Receives |
|---|---|---|
| bread-50/50-steelcut-80/20-flake-rice | Experimental | Other: 100% steel cut barley, Other: 100% barley flakes, Other: 50/50 rice-barley mix, Other: 80/20 rice-barley mix, Other: 100% rice, Other: white bread25 g of available carbohydrate was delivered to participants via (1) white bread, followed by (2) 50/50 rice-barley mix, followed by (3) 100% steel cut barley, followed by (4) 80/20 rice-barley mix, followed by (5) 100% barley flakes, followed by (6) 100% rice |
| 50/50-steelcut-80/20-flake-rice-bread | Experimental | Other: 100% steel cut barley, Other: 100% barley flakes, Other: 50/50 rice-barley mix, Other: 80/20 rice-barley mix, Other: 100% rice, Other: white bread25 g of available carbohydrate was delivered to participants via (1) 50/50 rice-barley mix, followed by (2) 100% steel cut barley, followed by (3) 80/20 rice-barley mix, followed by (4) 100% barley flakes, followed by (5) 100% rice, followed by (6) white bread |
| steelcut-80/20-flake-rice-bread-50/50 | Experimental | Other: 100% steel cut barley, Other: 100% barley flakes, Other: 50/50 rice-barley mix, Other: 80/20 rice-barley mix, Other: 100% rice, Other: white bread25 g of available carbohydrate was delivered to participants via (1) 100% steel cut barley, followed by (2) 80/20 rice-barley mix, followed by (3) 100% barley flakes, followed by (4) 100% rice, followed by (5) white bread, followed by (6) 50/50 rice-barley mix |
| 80/20-flake-rice-bread-50/50-steelcut | Experimental | Other: 100% steel cut barley, Other: 100% barley flakes, Other: 50/50 rice-barley mix, Other: 80/20 rice-barley mix, Other: 100% rice, Other: white bread25 g of available carbohydrate was delivered to participants via (1) 80/20 rice-barley mix, followed by (2) 100% barley flakes, followed by (3) 100% rice, followed by (4) white bread, followed by (5) 50/50 rice-barley mix, followed by (6) 100% steel cut barley |
| flake-rice-bread-50/50-steelcut-80/20 | Experimental | Other: 100% steel cut barley, Other: 100% barley flakes, Other: 50/50 rice-barley mix, Other: 80/20 rice-barley mix, Other: 100% rice, Other: white bread25 g of available carbohydrate was delivered to participants via (1) 100% barley flakes, followed by (2) 100% rice, followed by (3) white bread, followed by (4) 50/50 rice-barley mix, followed by (5) 100% steel cut barley, followed by (6) 80/20 rice-barley mix |
| rice-bread-50/50-steelcut-80/20-flake | Experimental | Other: 100% steel cut barley, Other: 100% barley flakes, Other: 50/50 rice-barley mix, Other: 80/20 rice-barley mix, Other: 100% rice, Other: white bread25 g of available carbohydrate was delivered to participants via (1) 100% rice, followed by (2) white bread, followed by (3) 50/50 rice-barley mix, followed by (4) 100% steel cut barley, followed by (5) 80/20 rice-barley mix, followed by (6) 100% barley flakes |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy, English speaking adults;
- BMI between 18 and 30 kg/m2
Key exclusion criteria (5 listed)
- History of GI malabsorption diseases, food allergy or intolerance to gluten;
- Prediabetes, and/or diabetes, and/or treatment with diabetic medications for any reason;
- Hypertension, hypothyroidism and other chronic disease that affects nutrient metabolism;
- Any women pregnant or lactating, or expecting to become pregnant during the study;
- Individuals with a history of bleeding disorders
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 |
|---|---|---|
| 100% steel cut barley25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC). | Other | 50/50-steelcut-80/20-flake-rice-bread, 80/20-flake-rice-bread-50/50-steelcut, bread-50/50-steelcut-80/20-flake-rice, flake-rice-bread-50/50-steelcut-80/20, rice-bread-50/50-steelcut-80/20-flake, steelcut-80/20-flake-rice-bread-50/50 |
| 100% barley flakes25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC). | Other | 50/50-steelcut-80/20-flake-rice-bread, 80/20-flake-rice-bread-50/50-steelcut, bread-50/50-steelcut-80/20-flake-rice, flake-rice-bread-50/50-steelcut-80/20, rice-bread-50/50-steelcut-80/20-flake, steelcut-80/20-flake-rice-bread-50/50 |
| 50/50 rice-barley mix25 g of available carbohydrate was delivered to participants via a 50/50 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC). | Other | 50/50-steelcut-80/20-flake-rice-bread, 80/20-flake-rice-bread-50/50-steelcut, bread-50/50-steelcut-80/20-flake-rice, flake-rice-bread-50/50-steelcut-80/20, rice-bread-50/50-steelcut-80/20-flake, steelcut-80/20-flake-rice-bread-50/50 |
| 80/20 rice-barley mix25 g of available carbohydrate was delivered to participants via a 80/20 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC). | Other | 50/50-steelcut-80/20-flake-rice-bread, 80/20-flake-rice-bread-50/50-steelcut, bread-50/50-steelcut-80/20-flake-rice, flake-rice-bread-50/50-steelcut-80/20, rice-bread-50/50-steelcut-80/20-flake, steelcut-80/20-flake-rice-bread-50/50 |
| 100% rice25 g of available carbohydrate was delivered to participants via Goya medium grain white rice | Other | 50/50-steelcut-80/20-flake-rice-bread, 80/20-flake-rice-bread-50/50-steelcut, bread-50/50-steelcut-80/20-flake-rice, flake-rice-bread-50/50-steelcut-80/20, rice-bread-50/50-steelcut-80/20-flake, steelcut-80/20-flake-rice-bread-50/50 |
| white bread25 g of available carbohydrate was delivered to participants via Sara Lee Classic White Bread (Bimbo Bakeries USA, Inc.) | Other | 50/50-steelcut-80/20-flake-rice-bread, 80/20-flake-rice-bread-50/50-steelcut, bread-50/50-steelcut-80/20-flake-rice, flake-rice-bread-50/50-steelcut-80/20, rice-bread-50/50-steelcut-80/20-flake, steelcut-80/20-flake-rice-bread-50/50 |
Primary outcome
Post-prandial glycemia
Time frame: 0 min, 15 min, 30 min, 45min , 60 min, 90 min, 120 min
Incremental area under the curve(iAUC) for plasma glucose concentrations were measured at 0, 15, 30, 45, 60, 90 and 120 min using the trapezoidal method to evaluate the glycemic response to each grain treatment.
4 secondary outcomes
Self-reported hunger
Time frame: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min
Self-reported satiety
Time frame: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min
Self-reported fullness
Time frame: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min
Self-reported prospective food consumption
Time frame: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min
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 2 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Corrie M Whisner, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100% steel cut barley, 100% barley flakes and 50/50 rice-barley mix in people with Blood Glucose and Dietary Fiber, run by Arizona State University at 1 site in United States.
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 2 inclusion and 5 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 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Post-prandial glycemia (time frame: 0 min, 15 min, 30 min, 45min , 60 min, 90 min, 120 min). 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 2 Jan 2018.