HealthyNCT05556837
Effect of Extruded Cereals Enriched With β-glucan on Postprandial Plasma Glucose and Serum Insulin Responses
A study testing OBG Cereal and BBG Cereal in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Canada.
Trial summary
β-glucan (BG) is a viscous dietary fiber present in barley and oats that, when added to carbohydrate containing foods, reduces the postprandial glycemic response (PPGR), which is considered to be beneficial to health. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- OBG Cereal and BBG Cereal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 4 Mar 2024to 26 Jun 2024
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who are non-pregnant, non-lactating aged 20-65 years of age, inclusive.
- Body mass index 18.0 to 29.9 kg/m², inclusive.
- Nonsmokers (tobacco, cannabis, vaping).
- Fasting glucose concentration <7.0 mmol/L (126 mg/dL), determined by a fasting finger-stick blood sample (plasma) at screening.
- Willing to abstain from unusual levels of food intake, unusual or strenuous exercise, smoking or consuming alcoholic drinks 24 hours before study days.
- Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
- Willing to comply with the protocol.
- Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as the Ontario Health Insurance Plan.
Who cannot join
- Failure to meet any one of the inclusion criteria.
- Systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg at screening.
- Change in body weight of >3.5kg (>7.7 lbs.) within 4 weeks of the screening visit.
- Practicing any extreme dietary habits, as judged by the Investigator (i.e., Atkins diet, very high protein diet, etc.).
- Major trauma or major medical or surgical event within 3 months of screening.
- History or presence of clinically important endocrine, cardiovascular, pulmonary, biliary, or gastrointestinal disorders.
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- The use of medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, thiazolidinediones, metformin, and systemic corticosteroids, or with any condition or use of any medication which might, in the opinion of the Qualified Investigator (QI), either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- Use of supplements containing chromium (intended for glucose management), ginseng or cinnamon, within 3 weeks of screening.
- Changes in the doses of permissible prescription drugs within 3 months of screening or changes in the doses of over-the-counter drugs or permissible supplements within 3 weeks of screening.
- History of cancer in the prior two years, except for non-melanoma skin cancer.
- Recent history (within 12 months of screening) or strong potential for alcohol or substance abuse, where alcohol abuse is defined as > 14 drinks per week (1 drink=12 oz beer, 5 oz wine, or 1.5 oz distilled spirits).
- Known intolerance, sensitivity, or allergy to any ingredients in the study test meals.
- Unwillingness or inability to comply with the experimental procedures and to follow INQUIS health and safety policies.
- Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement, or lifestyle modification.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Extruded Cereals Enriched With β-glucan From Oats or Barley on Postprandial Plasma Glucose and Serum Insulin Responses in Generally Healthy Adults
β-glucan (BG) is a viscous dietary fiber present in barley and oats that, when added to carbohydrate containing foods, reduces the postprandial glycemic response (PPGR), which is considered to be beneficial to health. In 2011, the European Food Safety Authority (EFSA) concluded that 4g of either oat BG (OBG) or barley BG (BBG) per 30g available carbohydrate (avCHO) is required to obtain a reduction in PPGR, however this is an impractically large amount of BG to incorporate into palatable foods. A recent systematic review and meta-analysis found that doses of OBG well below 4g/30g avCHO can significantly reduce PPGR.
It is therefore hypothesized that 25g avCHO portions of cereal containing 1.4-1.5g of either OBG or BBG will elicit a statistically significantly lower PPGR compared to a control cereal containing no BG.
Read the detailed description
Statistical Analysis:
Analysis populations: The intention-to-treat (ITT) population includes all subjects who consumed at least 1 of the 3 test meals in that phase. The per-protocol (PP) population for each phase includes all subjects who completed all 3 tests in that phase with no serious protocol violations. There may also be a group, termed PPDO (dropouts), defined as the PP population plus subjects who competed 1 or 2 of the 3 tests with no serious protocol violations.
Conclusions will be based on the glucose and insulin endpoints for the PP population. To assess the potential impact of excluding those subjects who dropped out after completing 1 or 2 tests, a secondary analysis will be performed for the PP+DO population where the missing values are imputed using methods described by Snedecor and Cochran.
Distribution of data: the methods of analyzing continuous data assume that the data are normally distributed. Normality of distribution will be tested by comparing the actual distribution of the Z scores to the expected distribution using the chi-square test with the data taken to be normally distributed if p>0.05. Non-normally distributed data will be transformed by (in order of preference) log-transformation, square-root-transformation, some other method, until the transformed data are normally distributed.
Primary endpoint: the primary endpoint will be assessed as follows: serum glucose concentrations will be subjected to repeated-measures analysis of variance (ANOVA) using the linear model analyzing for the main effects of time and treatment and the time×treatment interaction. After demonstrating a significant time×treatment interaction (indicating that the pattern of glucose response differs significantly among treatments), the values for iAUC 0-2h will be analyzed by ANOVA for the main effect of treatment; after demonstrating significant heterogeneity, the mean for each of the 2 test cereals will be compared only to that of each respective control cereal using Dunnett's Test to adjust for multiple comparisons. The 2 test cereals will not be compared to each other. The criterion for significance will be two-tailed p<0.05.
Secondary endpoints: the results for insulin iAUC will be assessed as described for the primary endpoint. Serum glucose and insulin concentrations and increments at each time point will be subjected to repeated-measures ANOVA. Upon demonstration of significant heterogeneity, individual means of the test and matched control cereals will be compared using Dunnett's Test to adjust for multiple comparisons. The 2 test cereals will not be compared to each other. The criterion for significance will be two-tailed p<0.05.
Statistical Power:
The average within-individual CV of glucose iAUC elicited by repeated tests of oral glucose is within the range of 22-25% in our previous studies in healthy individuals. To demonstrate that both test cereals differ significantly from the control, each comparison must have 90% power to detect a significant difference in order to obtain 80% power to detect both significant differences (since 0.902 = 0.81). Assuming a SD of 25% and using the normal distribution, n=40 subjects provide 95% power to detect a significant difference of 20% between test and control cereals.
- Conditions
- Healthy
- Being tested
- Control Cereal, OBG Cereal, BBG Cereal
- Keywords
- Postprandial glucose, Postprandial insulin, Beta Glucan, Oats, Barley
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control CerealOther
A portion of cereal (25g available carbohydrate), served with 125ml of 2% milk and 250ml water, will be fed to participants and postprandial glucose and insulin will be measured
OBG CerealOther
A portion of cereal (25g available carbohydrate) containing OBG, served with 125ml of 2% milk and 250ml of water, will be fed to participants and postprandial glucose and insulin will be measured
BBG CerealOther
A portion of cereal (25g available carbohydrate) containing BBG, served with 125ml of 2% milk and 250ml of water, will be fed to participants and postprandial glucose and insulin will be measured
| Study group | Role | What they receive |
|---|---|---|
| Control Cereal | Placebo comparator | A portion of cereal (25g available carbohydrate) that contains no beta-glucan Receives: Other: Control Cereal |
| OBG Cereal | Experimental | A portion of cereal (25g available carbohydrate) that contains approximately 1.4g of oat beta-glucan (OBG) Receives: Other: OBG Cereal |
| BBG Cereal | Experimental | A portion of cereal (25g available carbohydrate) that contains approximately 1.4g of barley beta-glucan (BBG) Receives: Other: BBG Cereal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Glucose Incremental Area under the Curve (iAUC) from 0-2 hours
iAUC, ignoring area below baseline, will be calculated from glucose concentrations in plasma obtained from finger prick blood samples. The mean glucose concentration at -5 and 0 minutes will be taken as the baseline.
Measured: Plasma glucose will be measured for 2 hours after consumption of the cereals (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Secondary outcomes (9)
Postprandial Insulin iAUC from 0-2 hours
iAUC, ignoring area below baseline, will be calculated from insulin concentrations in serum obtained from finger prick blood samples. The mean insulin concentration at -5 and 0 minutes will be taken as the baseline.
Measured: Serum insulin will be measured for 2 hours after consumption of the cereals (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Peak Rise of glucose
the maximum postprandial increments (peak rises) of glucose defined as the maximum concentration achieved minus the baseline (mean of concentrations at -5 and 0 min)
Measured: Glucose will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Peak Rise of insulin
the maximum postprandial increments (peak rises) of insulin defined as the maximum concentration achieved minus the baseline (mean of concentrations at -5 and 0 min)
Measured: Insulin will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Gmax
The maximum postprandial concentration of glucose (Gmax) achieved over the 2h test period
Measured: Glucose will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Imax
The maximum postprandial concentration of insulin (Imax) achieved over the 2h test period
Measured: Insulin will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Time of Gmax
The time when the maximum postprandial concentration of glucose (Gmax) occurred during 2h test period
Measured: Insulin will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Time of Imax
The time when the maximum postprandial concentration of insulin (Imax) occurred during 2h test period
Measured: Insulin will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Glucose concentrations and increments at each time point
Glucose concentrations and increments at each time point
Measured: Glucose will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Insulin concentrations and increments at each time point
Insulin concentrations and increments at each time point
Measured: Glucose and insulin will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start4 Mar 2024
- Primary completion26 Apr 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a double-blinded, randomized, crossover design with all subjects completing all 3 tests.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research, Cereal Partners Worldwide
- Responsible party
- Sponsor
- Investigators
- Thomas Wolever, DM, PhD, Principal investigator, INQUIS Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556837
- Sponsor's protocol ID
- INQ-2203
- Status last verified
- Jun 2025
- First submitted
- 22 Sep 2022
- Last updated
- 1 Jul 2025
- 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extruded Cereals Enriched With β-glucan From Oats or Barley on Postprandial Plasma Glucose and Serum Insulin Responses in Generally Healthy Adults
- ClinicalTrials.gov ID
- NCT05556837
- Acronym / sponsor ID
- INQ-2203
- Conditions
- Healthy
- Keywords
- Postprandial glucose, Postprandial insulin, Beta Glucan, Oats, Barley
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research, Cereal Partners Worldwide
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 27 Sep 2022 (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.
β-glucan (BG) is a viscous dietary fiber present in barley and oats that, when added to carbohydrate containing foods, reduces the postprandial glycemic response (PPGR), which is considered to be beneficial to health. In 2011, the European Food Safety Authority (EFSA) concluded that 4g of either oat BG (OBG) or barley BG (BBG) per 30g available carbohydrate (avCHO) is required to obtain a reduction in PPGR, however this is an impractically large amount of BG to incorporate into palatable foods. A recent systematic review and meta-analysis found that doses of OBG well below 4g/30g avCHO can significantly reduce PPGR.
It is therefore hypothesized that 25g avCHO portions of cereal containing 1.4-1.5g of either OBG or BBG will elicit a statistically significantly lower PPGR compared to a control cereal containing no BG.
Detailed description
Statistical Analysis:
Analysis populations: The intention-to-treat (ITT) population includes all subjects who consumed at least 1 of the 3 test meals in that phase. The per-protocol (PP) population for each phase includes all subjects who completed all 3 tests in that phase with no serious protocol violations. There may also be a group, termed PPDO (dropouts), defined as the PP population plus subjects who competed 1 or 2 of the 3 tests with no serious protocol violations.
Conclusions will be based on the glucose and insulin endpoints for the PP population. To assess the potential impact of excluding those subjects who dropped out after completing 1 or 2 tests, a secondary analysis will be performed for the PP+DO population where the missing values are imputed using methods described by Snedecor and Cochran.
Distribution of data: the methods of analyzing continuous data assume that the data are normally distributed. Normality of distribution will be tested by comparing the actual distribution of the Z scores to the expected distribution using the chi-square test with the data taken to be normally distributed if p>0.05. Non-normally distributed data will be transformed by (in order of preference) log-transformation, square-root-transformation, some other method, until the transformed data are normally distributed.
Primary endpoint: the primary endpoint will be assessed as follows: serum glucose concentrations will be subjected to repeated-measures analysis of variance (ANOVA) using the linear model analyzing for the main effects of time and treatment and the time×treatment interaction. After demonstrating a significant time×treatment interaction (indicating that the pattern of glucose response differs significantly among treatments), the values for iAUC 0-2h will be analyzed by ANOVA for the main effect of treatment; after demonstrating significant heterogeneity, the mean for each of the 2 test cereals will be compared only to that of each respective control cereal using Dunnett's Test to adjust for multiple comparisons. The 2 test cereals will not be compared to each other. The criterion for significance will be two-tailed p<0.05.
Secondary endpoints: the results for insulin iAUC will be assessed as described for the primary endpoint. Serum glucose and insulin concentrations and increments at each time point will be subjected to repeated-measures ANOVA. Upon demonstration of significant heterogeneity, individual means of the test and matched control cereals will be compared using Dunnett's Test to adjust for multiple comparisons. The 2 test cereals will not be compared to each other. The criterion for significance will be two-tailed p<0.05.
Statistical Power:
The average within-individual CV of glucose iAUC elicited by repeated tests of oral glucose is within the range of 22-25% in our previous studies in healthy individuals. To demonstrate that both test cereals differ significantly from the control, each comparison must have 90% power to detect a significant difference in order to obtain 80% power to detect both significant differences (since 0.902 = 0.81). Assuming a SD of 25% and using the normal distribution, n=40 subjects provide 95% power to detect a significant difference of 20% between test and control cereals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study is a double-blinded, randomized, crossover design with all subjects completing all 3 tests.
| Arm | Type | Receives |
|---|---|---|
| Control Cereal | Placebo comparator | Other: Control CerealA portion of cereal (25g available carbohydrate) that contains no beta-glucan |
| OBG Cereal | Experimental | Other: OBG CerealA portion of cereal (25g available carbohydrate) that contains approximately 1.4g of oat beta-glucan (OBG) |
| BBG Cereal | Experimental | Other: BBG CerealA portion of cereal (25g available carbohydrate) that contains approximately 1.4g of barley beta-glucan (BBG) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals who are non-pregnant, non-lactating aged 20-65 years of age, inclusive.
- Body mass index 18.0 to 29.9 kg/m², inclusive.
- Nonsmokers (tobacco, cannabis, vaping).
- Fasting glucose concentration <7.0 mmol/L (126 mg/dL), determined by a fasting finger-stick blood sample (plasma) at screening.
- Willing to abstain from unusual levels of food intake, unusual or strenuous exercise, smoking or consuming alcoholic drinks 24 hours before study days.
Key exclusion criteria (14 listed)
- Failure to meet any one of the inclusion criteria.
- Systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg at screening.
- Change in body weight of >3.5kg (>7.7 lbs.) within 4 weeks of the screening visit.
- Practicing any extreme dietary habits, as judged by the Investigator (i.e., Atkins diet, very high protein diet, etc.).
- Major trauma or major medical or surgical event within 3 months of screening.
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 |
|---|---|---|
| Control CerealA portion of cereal (25g available carbohydrate), served with 125ml of 2% milk and 250ml water, will be fed to participants and postprandial glucose and insulin will be measured | Other | Control Cereal |
| OBG CerealA portion of cereal (25g available carbohydrate) containing OBG, served with 125ml of 2% milk and 250ml of water, will be fed to participants and postprandial glucose and insulin will be measured | Other | OBG Cereal |
| BBG CerealA portion of cereal (25g available carbohydrate) containing BBG, served with 125ml of 2% milk and 250ml of water, will be fed to participants and postprandial glucose and insulin will be measured | Other | BBG Cereal |
Primary outcome
Postprandial Glucose Incremental Area under the Curve (iAUC) from 0-2 hours
Time frame: Plasma glucose will be measured for 2 hours after consumption of the cereals (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
iAUC, ignoring area below baseline, will be calculated from glucose concentrations in plasma obtained from finger prick blood samples. The mean glucose concentration at -5 and 0 minutes will be taken as the baseline.
9 secondary outcomes
Postprandial Insulin iAUC from 0-2 hours
Time frame: Serum insulin will be measured for 2 hours after consumption of the cereals (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Peak Rise of glucose
Time frame: Glucose will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Peak Rise of insulin
Time frame: Insulin will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Gmax
Time frame: Glucose will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Imax
Time frame: Insulin will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Time of Gmax
Time frame: Insulin will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Time of Imax
Time frame: Insulin will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Glucose concentrations and increments at each time point
Time frame: Glucose will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
Insulin concentrations and increments at each time point
Time frame: Glucose and insulin will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)
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 1 Jul 2025.
- 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.
Thomas Wolever, DM, PhD principal investigator
INQUIS Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OBG Cereal and BBG Cereal in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Canada.
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 8 inclusion and 14 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 1 Jul 2025. 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 Canada. 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. Some participants in this study may receive a placebo. 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 Glucose Incremental Area under the Curve (iAUC) from 0-2 hours (time frame: Plasma glucose will be measured for 2 hours after consumption of the cereals (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)). 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 1 Jul 2025.