Blood Glucose ResponseNCT05291806
Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response
A study testing Reference Product, Wholegrain product Dose A and Wholegrain product Dose B in people with Blood Glucose Response, run by Aventure AB at 1 site in Sweden.
Trial summary
The aim of this study is to investigate second meal effects of a wholegrain cereal product on blood glucose response. The wholegrain cereal product will be consumed in the evening and blood glucose analyzed after a standardized breakfast meal the following morning. 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 Response
- What is being tested?
- Reference Product, Wholegrain product Dose A and Wholegrain product Dose B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteSweden
- Study dates
- 17 Mar 2022to 13 Jun 2022
- 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 18.5-29.9 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, 2, 3 or 4)
- 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
Show all 18Show fewer
- Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
- Allergy to ingredients included in investigational product, reference, or standardized meal
- Participants restricted to a vegetarian or vegan diet
- Intolerance to gluten
- Individuals who are averse to venous catheterization or 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
The aim of this study is to investigate second meal effects of a wholegrain cereal product on blood glucose response. The wholegrain cereal product will be consumed in the evening and blood glucose analyzed after a standardized breakfast meal the following morning.
- Conditions
- Blood Glucose Response
- Being tested
- Reference Product, Wholegrain product Dose A, Wholegrain product Dose B, Wholegrain product Dose A, cut kernels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference ProductOther
This intervention is based on white rice.
Wholegrain product Dose AOther
This wholegrain intervention contains whole cereal kernels.
Wholegrain product Dose BOther
This wholegrain intervention contains whole cereal kernels.
Wholegrain product Dose A, cut kernelsOther
This wholegrain intervention contains cut cereal kernels.
| Study group | Role | What they receive |
|---|---|---|
| Reference | Placebo comparator | Not described Receives: Other: Reference Product |
| Whole cereal kernels Dose A | Active comparator | Not described Receives: Other: Wholegrain product Dose A |
| Whole cereal kernels Dose B | Active comparator | Not described Receives: Other: Wholegrain product Dose B |
| Cut cereal kernels Dose A | Active comparator | Not described Receives: Other: Wholegrain product Dose A, cut kernels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial capillary blood glucose iAUC (0-120 min)
The change in capillary blood glucose between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
Measured: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Secondary outcomes (11)
Postprandial capillary blood glucose Cmax
The change in capillary blood glucose between wholegrain products and reference in 2-hour Cmax(0-120 min) (maximum concentration) after the breakfast meal.
Measured: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Postprandial capillary blood glucose Tmax
The change in capillary blood glucose between wholegrain products and reference in 2-hour Tmax(0-120 min) (the time to maximum concentration) after the breakfast meal.
Measured: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Fasting capillary blood glucose
The change in fasting capillary blood glucose the morning after consuming either wholegrain products or reference.
Measured: Outcome measures will be assessed just before the standardized meal is consumed.
Postprandial capillary blood glucose iAUC (0-60 min)
The change in capillary blood glucose between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
Measured: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Postprandial capillary blood glucose 2-hour iPeak(0-120 min) (incremental maximum value)
The change in capillary blood glucose between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal.
Measured: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Postprandial Insulin iAUC(0-120 min)
The change in venous blood insulin between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
Measured: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Postprandial Insulin Cmax
The change in venous blood insulin between wholegrain products and reference in Cmax after the standardized breakfast meal.
Measured: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Postprandial Insulin Tmax
The change in venous blood insulin between wholegrain products and reference in Tmax after the standardized breakfast meal.
Measured: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Fasting Insulin
The change in fasting venous blood insulin the morning after consuming either wholegrain products or reference.
Measured: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Postprandial insulin iAUC (0-60 min)
The change in venous blood insulin between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
Measured: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Postprandial venous blood insulin 2-hour iPeak(0-120 min) (incremental maximum value)
The change in venous blood insulin between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal.
Measured: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start17 Mar 2022
- Primary completion13 Jun 2022
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose ResponseStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aventure AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291806
- Sponsor's protocol ID
- TSP2201
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 5 Jul 2022
- 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 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response
- ClinicalTrials.gov ID
- NCT05291806
- Acronym / sponsor ID
- TSP2201
- Conditions
- Blood Glucose Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Aventure ABIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 23 Mar 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.
The aim of this study is to investigate second meal effects of a wholegrain cereal product on blood glucose response. The wholegrain cereal product will be consumed in the evening and blood glucose analyzed after a standardized breakfast meal the following morning.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Reference | Placebo comparator | Other: Reference Product |
| Whole cereal kernels Dose A | Active comparator | Other: Wholegrain product Dose A |
| Whole cereal kernels Dose B | Active comparator | Other: Wholegrain product Dose B |
| Cut cereal kernels Dose A | Active comparator | Other: Wholegrain product Dose A, cut kernels |
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 18.5-29.9 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 (18 listed)
- Elevated fasting blood glucose (above 6.1 mmol/L at fasting on visit 1, 2, 3 or 4)
- 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 |
|---|---|---|
| Reference ProductThis intervention is based on white rice. | Other | Reference |
| Wholegrain product Dose AThis wholegrain intervention contains whole cereal kernels. | Other | Whole cereal kernels Dose A |
| Wholegrain product Dose BThis wholegrain intervention contains whole cereal kernels. | Other | Whole cereal kernels Dose B |
| Wholegrain product Dose A, cut kernelsThis wholegrain intervention contains cut cereal kernels. | Other | Cut cereal kernels Dose A |
Primary outcome
Postprandial capillary blood glucose iAUC (0-120 min)
Time frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
The change in capillary blood glucose between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
11 secondary outcomes
Postprandial capillary blood glucose Cmax
Time frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Postprandial capillary blood glucose Tmax
Time frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Fasting capillary blood glucose
Time frame: Outcome measures will be assessed just before the standardized meal is consumed.
Postprandial capillary blood glucose iAUC (0-60 min)
Time frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Postprandial capillary blood glucose 2-hour iPeak(0-120 min) (incremental maximum value)
Time frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Postprandial Insulin iAUC(0-120 min)
Time frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Postprandial Insulin Cmax
Time frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Postprandial Insulin Tmax
Time frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Fasting Insulin
Time frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Postprandial insulin iAUC (0-60 min)
Time frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Postprandial venous blood insulin 2-hour iPeak(0-120 min) (incremental maximum value)
Time frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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 5 Jul 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reference Product, Wholegrain product Dose A and Wholegrain product Dose B in people with Blood Glucose Response, 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 18 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 5 Jul 2022. 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?
Postprandial capillary blood glucose iAUC (0-120 min) (time frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.). 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 5 Jul 2022.