Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response

June 29, 2022 updated by: Aventure AB
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden
        • Aventure AB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or Female, 35 to 65 years of age
  2. BMI 18.5-29.9 kg/m2
  3. Agree to maintain consistent dietary habits and physical activity levels for the duration of the study.
  4. Healthy as determined by medical history and information provided by the volunteer.
  5. Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits.
  6. Has given voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

  1. Elevated fasting blood glucose (above 6.1 mmol/L at fasting on visit 1, 2, 3 or 4)
  2. Women who are pregnant or breast feeding
  3. Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
  4. 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.
  5. Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
  6. Use of antibiotics within 2 weeks of enrollment
  7. Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
  8. Allergy to ingredients included in investigational product, reference, or standardized meal
  9. Participants restricted to a vegetarian or vegan diet
  10. Intolerance to gluten
  11. Individuals who are averse to venous catheterization or capillary blood sampling
  12. Currently active smokers (or using other tobacco products, and e-cigarettes)
  13. Unstable medical conditions as determined by QI
  14. Participation in other clinical research trials
  15. Individuals who are cognitively impaired and/or who are unable to give informed consent
  16. Acute infection

  17. 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

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Reference
Other: Reference Product
This intervention is based on white rice.
Active Comparator: Whole cereal kernels Dose A
Other: Wholegrain product Dose A
This wholegrain intervention contains whole cereal kernels.
Active Comparator: Whole cereal kernels Dose B
Other: Wholegrain product Dose B
This wholegrain intervention contains whole cereal kernels.
Active Comparator: Cut cereal kernels Dose A
Other: Wholegrain product Dose A, cut kernels
This wholegrain intervention contains cut cereal kernels.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postprandial capillary blood glucose Cmax
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 2-hour Cmax(0-120 min) (maximum concentration) after the breakfast meal.
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.
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.
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.
The change in fasting capillary blood glucose the morning after consuming either wholegrain products or reference.
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.
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.
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.
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.
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.
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.
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.
The change in venous blood insulin between wholegrain products and reference in Cmax after the standardized breakfast meal.
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.
The change in venous blood insulin between wholegrain products and reference in Tmax after the standardized breakfast meal.
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.
The change in fasting venous blood insulin the morning after consuming either wholegrain products or reference.
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.
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.
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.
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.
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fasting GLP-1
Time Frame: Outcome measures will be assessed just before the standardized meal is consumed.
The change in fasting GLP-1 the morning after consuming either wholegrain products or reference.
Outcome measures will be assessed just before the standardized meal is consumed.
GLP-1 iAUC(0-120 min)
Time Frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
The change in GLP-1 between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
GLP-1 iAUC(0-60 min)
Time Frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
The change in GLP-1 between wholegrain products and reference in the1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
GLP-1 Cmax
Time Frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
The changein GLP-1 between wholegrain products and reference in Cmax after the standardized breakfast meal.
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
GLP-1 Tmax
Time Frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
The change in GLP-1 between wholegrain products and reference in Tmax after the standardized breakfast meal.
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
Fasting PYY
Time Frame: Outcome measures will be assessed just before the standardized meal is consumed.
The change in fasting PYY the morning after consuming either wholegrain products or reference.
Outcome measures will be assessed just before the standardized meal is consumed.
PYY 2-hour mean concentration
Time Frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
The change in PYY between the wholegrain products and the reference in the 2-hour mean concentration after the breakfast meal.
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
PYY 1-hour mean concentration
Time Frame: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
The change in PYY between the wholegrain products and the reference in the 1-hour mean concentration after the breakfast meal.
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aventure AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TSP2201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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