Blood GlucoseNCT04888559
Effects of a Whole Grain Cereal Product on Blood Glucose Response After 3 Consecutive Meals
A study testing Breakfast product: Whole grain and Breakfast product: Reference in people with Blood Glucose, run by Aventure AB at 1 site in Sweden.
Trial summary
In this pilot study it will be investigated if a whole grain product will improve the glucose response not only when it is eaten at breakfast, but also at the two following meals; lunch and dinner (2nd and 3rd meal effect) in a healthy population. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose
- What is being tested?
- Breakfast product: Whole grain and Breakfast product: Reference
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 6 May 2021to 15 Jun 2021
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female, 35 to 65 years of age
- BMI 22-29 (±0.5) kg/m2
- Agree to maintain consistent dietary habits and physical activity levels for the duration of the study.
- Healthy as determined by medical history and information provided by the volunteer.
- Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits.
- Has given voluntary, written, informed consent to participate in the study.
Who cannot join
- Elevated fasting blood glucose (above 6.1 mmol/L at fasting on visit 1 or 2)
- Women who are pregnant or breast feeding
- Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
- Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the QI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless other is recommended by their physician.
- Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
- Use of antibiotics within 2 weeks of enrollment
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- Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
- Allergy to ingredients included in investigational product, placebo, or standardized meal
- Participants restricted to a vegetarian or vegan diet
- Intolerance to gluten
- Individuals who are averse to capillary blood sampling
- Currently active smokers (or using other tobacco products, and e-cigarettes)
- Unstable medical conditions as determined by QI
- Participation in other clinical research trials
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Acute infection
- Any other condition which in the QI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
Trial locations and contacts
1 site in 1 country.
About this study
In this pilot study it will be investigated if a whole grain product will improve the glucose response not only when it is eaten at breakfast, but also at the two following meals; lunch and dinner (2nd and 3rd meal effect) in a healthy population.
- Conditions
- Blood Glucose
- Being tested
- Breakfast product: Whole grain, Breakfast product: Reference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast product: Whole grainOther
This intervention is a whole grain-based breakfast product containing oats and barley.
Breakfast product: ReferenceOther
This intervention is a rice-based breakfast product.
| Study group | Role | What they receive |
|---|---|---|
| Whole grain breakfast product | Active comparator | Not described Receives: Other: Breakfast product: Whole grain |
| Reference | Placebo comparator | Not described Receives: Other: Breakfast product: Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in capillary blood glucose between whole grain product and reference in the total incremental area under the curve iAUC(0-120 min) for all three meals (Breakfast iAUC0-120 min + Lunch iAUC0-120 min.+ Dinner iAUC0-120 min).
Measured: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
Secondary outcomes (5)
The difference in capillary blood glucose between whole grain product and reference in the 1, 2 and 3-hour incremental area under the curve (iAUC0-60 min, iAUC0-120 min and iAUC0-180 min) after the breakfast meal.
Measured: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products)
The difference in capillary blood glucose between whole grain product and reference in the 1, 2 and 3-hour incremental area under the curve (iAUC0-60 min, iAUC0-120 min and iAUC0-180 min) after the lunch meal.
Measured: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products) and 0-180 min after lunch (standardized meal))
The difference in capillary blood glucose between whole grain product and reference in the 1 and 2-hour incremental area under the curve (iAUC0-60 min and iAUC0-120 min) after the dinner meal.
Measured: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
The difference in capillary blood glucose between whole grain product and reference in 2-hour Cmax(0-120 min) (maximum concentration) after the breakfast, lunch and dinner meals respectively.
Measured: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
The difference in capillary blood glucose between whole grain product and reference in 2-hour Tmax(0-120 min) (the time to maximum concentration) after the breakfast, lunch and dinner meals respectively.
Measured: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start6 May 2021
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aventure AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Glucanova AB
- Responsible party
- Sponsor
- Investigators
- Kristina Andersson, PhD, Principal investigator, Aventure AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888559
- Sponsor's protocol ID
- TSP2101
- Status last verified
- Jun 2021
- First submitted
- 4 May 2021
- Last updated
- 29 Jun 2021
- Results posted
- 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 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Whole Grain Cereal Product on Blood Glucose Response After 3 Consecutive Meals
- ClinicalTrials.gov ID
- NCT04888559
- Acronym / sponsor ID
- TSP2101
- Conditions
- Blood Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Aventure ABIndustry (pharma, biotech, devices)
- Collaborators
- Glucanova AB
- Study start
- 6 May 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 17 May 2021 (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.
In this pilot study it will be investigated if a whole grain product will improve the glucose response not only when it is eaten at breakfast, but also at the two following meals; lunch and dinner (2nd and 3rd meal effect) in a healthy population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole grain breakfast product | Active comparator | Other: Breakfast product: Whole grain |
| Reference | Placebo comparator | Other: Breakfast product: Reference |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female, 35 to 65 years of age
- BMI 22-29 (±0.5) kg/m2
- Agree to maintain consistent dietary habits and physical activity levels for the duration of the study.
- Healthy as determined by medical history and information provided by the volunteer.
- Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits.
Key exclusion criteria (17 listed)
- Elevated fasting blood glucose (above 6.1 mmol/L at fasting on visit 1 or 2)
- Women who are pregnant or breast feeding
- Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
- Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the QI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless other is recommended by their physician.
- Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
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 |
|---|---|---|
| Breakfast product: Whole grainThis intervention is a whole grain-based breakfast product containing oats and barley. | Other | Whole grain breakfast product |
| Breakfast product: ReferenceThis intervention is a rice-based breakfast product. | Other | Reference |
Primary outcome
The difference in capillary blood glucose between whole grain product and reference in the total incremental area under the curve iAUC(0-120 min) for all three meals (Breakfast iAUC0-120 min + Lunch iAUC0-120 min.+ Dinner iAUC0-120 min).
Time frame: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
5 secondary outcomes
The difference in capillary blood glucose between whole grain product and reference in the 1, 2 and 3-hour incremental area under the curve (iAUC0-60 min, iAUC0-120 min and iAUC0-180 min) after the breakfast meal.
Time frame: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products)
The difference in capillary blood glucose between whole grain product and reference in the 1, 2 and 3-hour incremental area under the curve (iAUC0-60 min, iAUC0-120 min and iAUC0-180 min) after the lunch meal.
Time frame: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products) and 0-180 min after lunch (standardized meal))
The difference in capillary blood glucose between whole grain product and reference in the 1 and 2-hour incremental area under the curve (iAUC0-60 min and iAUC0-120 min) after the dinner meal.
Time frame: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
The difference in capillary blood glucose between whole grain product and reference in 2-hour Cmax(0-120 min) (maximum concentration) after the breakfast, lunch and dinner meals respectively.
Time frame: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
The difference in capillary blood glucose between whole grain product and reference in 2-hour Tmax(0-120 min) (the time to maximum concentration) after the breakfast, lunch and dinner meals respectively.
Time frame: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
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 29 Jun 2021.
- 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.
Kristina Andersson, PhD principal investigator
Aventure AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast product: Whole grain and Breakfast product: Reference in people with Blood Glucose, run by Aventure AB at 1 site in Sweden.
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 6 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 29 Jun 2021. 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 Sweden. 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?
The difference in capillary blood glucose between whole grain product and reference in the total incremental area under the curve iAUC(0-120 min) for all three meals (Breakfast iAUC0-120 min + Lunch iAUC0-120 min.+ Dinner iAUC0-120 min). (time frame: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))). 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 29 Jun 2021.