Diet, HealthyNCT06146322
Barley Beta-glucan, Glycemic Control, and Appetite
A study testing WR, LB and MB in people with Diet, Healthy and Blood Sugar; High, run by Washington State University at 1 site in United States.
Trial summary
Novel barley varieties high in the soluble fiber β-glucan have the capacity to improve population health through improving glycemic control. Sweetened and unsweetened wholegrain barley foods were tested in a randomized, controlled, crossover human clinical trial to assess impact on postprandial appetite and food… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Blood Sugar; High, Diabetes
- What is being tested?
- WR, LB and MB
- Type of treatment
- Pill or oral medicine
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 31 Oct 2020
- 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
- 18-50 years of age
- Body Mass Index (BMI) values of 18.5-40.0 kg/m2
- Normal fasting blood glucose (<100 mg/dL)
Who cannot join
- Use of medications known to be associated with weight change (e.g., beta-blockers)
- Use of steroid pills or shots such as prednisone or cortisone
- Use of nicotine
- Weight change of ten or more pounds in the last three months
- Major daily variation in physical activity (e.g., athletes in training)
- History of extensive small bowel surgery or surgery to treat obesity
Show all 17Show fewer
- History of heart attack, stroke, or bypass
- History of cancer within the last five years (exception: non-melanoma skin cancer)
- Recent or current medical diagnosis or medical treatment that would alter appetite, energy needs, satiety, and/or could impact the results of the trial
- Medical diagnoses of diabetes, cardiovascular disease, high levels of blood lipids, asthma, cold, and flu (exception: hypertension, if treated with medication prescribed more than three months prior to the screening activity)
- Fear of blood or needles
- Dietary restrictions that would interfere with consuming test foods (e.g., gluten intolerance, vegan, corn syrup allergy)
- Following a weight modification diet
- Sensitive to food textures present in the test foods
- Following personal schedules that would not permit attendance at all scheduled testing sessions
- Unable to comprehend the nature of the trial or instructions
- Unable to understand English sufficiently to complete the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington State University
Spokane, Washington, 99202
About this study
Novel barley varieties high in the soluble fiber β-glucan have the capacity to improve population health through improving glycemic control. Sweetened and unsweetened wholegrain barley foods were tested in a randomized, controlled, crossover human clinical trial to assess impact on postprandial appetite and food intake.
- Conditions
- Diet, Healthy, Blood Sugar; High, Diabetes, Appetite and General Nutritional Disorders, Appetitive Behavior
- Being tested
- WR, LB, MB, HB, WR+50g HFCS
- Keywords
- Beta-glucan, Fiber, Glycemic Control, Appetite
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus, Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WROther
Unsweetened preload condition: 240 mL white glutinous rice, 250 kcal, 0 g β-glucan
LBOther
Unsweetened preload condition: 240 mL low β-glucan barley, 250 kcal, ~4 g β-glucan
MBOther
Unsweetened preload condition: 240 mL medium β-glucan barley, 250 kcal, ~5 g β-glucan
HBOther
Unsweetened preload condition: 240 mL high β-glucan barley, 250 kcal, ~6 g β-glucan
WR+50g HFCSOther
Sweetened condition with high fructose corn syrup (HFCS): 240 mL white glutinous rice + 50g HFCS, 391 kcal, 0 g β-glucan
LB + 50 g HFCSOther
Sweetened condition with high fructose corn syrup (HFCS): 240 mL low β-glucan barley + 50 g HFCS, 391 kcal, ~4 g β-glucan
MB + 50 g HFCSOther
Sweetened condition with high fructose corn syrup (HFCS): 240 mL medium β-glucan barley + 50 g HFCS, 391 kcal, ~5 g β-glucan
HB + 50 g HFCSOther
Sweetened condition with high fructose corn syrup (HFCS): 240 mL high β-glucan barley + 50 g HFCS, 391 kcal, ~6 g β-glucan
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycemic response
Blood glucose measured every 15 minutes post-preload ingestion
Measured: 4 hours
Subjective appetite
Self-reported appetite measured using Visual Analogue Scale (VAS) every 15 minutes post-preload ingestion
Measured: 4 hours
Food intake
Food intake at a 16-item ad libitum test meal served 4 hours post-preload ingestion
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Oct 2019
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martine Perrigue, Washington State University
- Investigators
- Martine Perrigue, PhD, RDN, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146322
- Sponsor's protocol ID
- 17735
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 24 Nov 2023
- 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 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barley Beta-glucan, Glycemic Control, and Appetite
- ClinicalTrials.gov ID
- NCT06146322
- Acronym / sponsor ID
- 17735
- Conditions
- Diet, Healthy, Blood Sugar; High, Diabetes, Appetite and General Nutritional Disorders, Appetitive Behavior
- Keywords
- Beta-glucan, Fiber, Glycemic Control, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 24 Nov 2023 (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.
Novel barley varieties high in the soluble fiber β-glucan have the capacity to improve population health through improving glycemic control. Sweetened and unsweetened wholegrain barley foods were tested in a randomized, controlled, crossover human clinical trial to assess impact on postprandial appetite and food intake.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-50 years of age
- Body Mass Index (BMI) values of 18.5-40.0 kg/m2
- Normal fasting blood glucose (<100 mg/dL)
Key exclusion criteria (17 listed)
- Use of medications known to be associated with weight change (e.g., beta-blockers)
- Use of steroid pills or shots such as prednisone or cortisone
- Use of nicotine
- Weight change of ten or more pounds in the last three months
- Major daily variation in physical activity (e.g., athletes in training)
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 |
|---|---|---|
| WRUnsweetened preload condition: 240 mL white glutinous rice, 250 kcal, 0 g β-glucan | Other | – |
| LBUnsweetened preload condition: 240 mL low β-glucan barley, 250 kcal, ~4 g β-glucan | Other | – |
| MBUnsweetened preload condition: 240 mL medium β-glucan barley, 250 kcal, ~5 g β-glucan | Other | – |
| HBUnsweetened preload condition: 240 mL high β-glucan barley, 250 kcal, ~6 g β-glucan | Other | – |
| WR+50g HFCSSweetened condition with high fructose corn syrup (HFCS): 240 mL white glutinous rice + 50g HFCS, 391 kcal, 0 g β-glucan | Other | – |
| LB + 50 g HFCSSweetened condition with high fructose corn syrup (HFCS): 240 mL low β-glucan barley + 50 g HFCS, 391 kcal, ~4 g β-glucan | Other | – |
| MB + 50 g HFCSSweetened condition with high fructose corn syrup (HFCS): 240 mL medium β-glucan barley + 50 g HFCS, 391 kcal, ~5 g β-glucan | Other | – |
| HB + 50 g HFCSSweetened condition with high fructose corn syrup (HFCS): 240 mL high β-glucan barley + 50 g HFCS, 391 kcal, ~6 g β-glucan | Other | – |
Primary outcome
Postprandial glycemic response
Time frame: 4 hours
Blood glucose measured every 15 minutes post-preload ingestion
Subjective appetite
Time frame: 4 hours
Self-reported appetite measured using Visual Analogue Scale (VAS) every 15 minutes post-preload ingestion
Food intake
Time frame: 30 minutes
Food intake at a 16-item ad libitum test meal served 4 hours post-preload ingestion
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 24 Nov 2023.
- 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.
Martine Perrigue, PhD, RDN principal investigator
Washington 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 WR, LB and MB in people with Diet, Healthy and Blood Sugar; High, run by Washington 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 3 inclusion and 17 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 24 Nov 2023. 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?
Postprandial glycemic response (time frame: 4 hours). The study lists 3 primary outcomes in all. 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 24 Nov 2023.