Evaluation of Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products

July 2, 2019 updated by: Aventure AB

A Randomized, Single-blind, Crossover Study to Evaluate Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products

The objective of this study is to investigate the effect on postprandial glycaemia in a healthy population after intake of milk and oat based products.

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.

Detailed Description

Postprandial glycaemia, insulinaemia and GLP-1 will be measured after intake of test meals with equal amount of carbohydrates (adjusted using bread) and equal amount of total water.

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.
20

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

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female 20 to 40 years of age
  2. BMI 20-27 (±0.5) 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 (at or above 6.1 mmol/L at fasting on visit 2, 3, 4 or 5)
  2. Elevated fasting insulin (above 25 mIE/L)
  3. Women who are pregnant or breast feeding
  4. Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the SI
  5. 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 SI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless recommended by their physician.
  6. Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
  7. Use of antibiotics within 2 weeks of enrollment
  8. Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
  9. Allergy to ingredients included in investigational product, placebo or standardized meal
  10. Participants restricted to a vegetarian or vegan diet
  11. Intolerance to lactose or gluten
  12. Individuals who are averse to venous catheterization or capillary blood sampling
  13. Currently active smokers (or using other tobacco products, and e-cigarettes)
  14. Unstable medical conditions as determined by SI
  15. Participation in other clinical research trials
  16. Individuals who are cognitively impaired and/or who are unable to give informed consent
  17. Acute infection
  18. Any other condition which in the SI'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: Double

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: Bread reference
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread.
Other: Bread reference
Commercially available white wheat bread
Other: Product 1: Milk
Developed reference product based on milk
Other: Product 2: Full fat milk + oat
Developed product based on full fat milk with addition of oat
Other: Product 3: Skim milk + oat, high fibre
Developed product based on skim milk with addition of oat giving a high fiber content to the product
Other: Product 4: Skim milk + oat, low fibre
Developed product based on skim milk with addition of oat giving a lower fiber content to the product
Experimental: Product 1: Milk
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on milk.
Other: Bread reference
Commercially available white wheat bread
Other: Product 1: Milk
Developed reference product based on milk
Other: Product 2: Full fat milk + oat
Developed product based on full fat milk with addition of oat
Other: Product 3: Skim milk + oat, high fibre
Developed product based on skim milk with addition of oat giving a high fiber content to the product
Other: Product 4: Skim milk + oat, low fibre
Developed product based on skim milk with addition of oat giving a lower fiber content to the product
Experimental: Product 2: Full fat milk + oat
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on full fat milk and oat with high fiber content.
Other: Bread reference
Commercially available white wheat bread
Other: Product 1: Milk
Developed reference product based on milk
Other: Product 2: Full fat milk + oat
Developed product based on full fat milk with addition of oat
Other: Product 3: Skim milk + oat, high fibre
Developed product based on skim milk with addition of oat giving a high fiber content to the product
Other: Product 4: Skim milk + oat, low fibre
Developed product based on skim milk with addition of oat giving a lower fiber content to the product
Experimental: Product 3: Skim milk + oat, high fibre
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with high fiber content.
Other: Bread reference
Commercially available white wheat bread
Other: Product 1: Milk
Developed reference product based on milk
Other: Product 2: Full fat milk + oat
Developed product based on full fat milk with addition of oat
Other: Product 3: Skim milk + oat, high fibre
Developed product based on skim milk with addition of oat giving a high fiber content to the product
Other: Product 4: Skim milk + oat, low fibre
Developed product based on skim milk with addition of oat giving a lower fiber content to the product
Experimental: Product 4: Skim milk + oat, low fibre
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with low fiber content.
Other: Bread reference
Commercially available white wheat bread
Other: Product 1: Milk
Developed reference product based on milk
Other: Product 2: Full fat milk + oat
Developed product based on full fat milk with addition of oat
Other: Product 3: Skim milk + oat, high fibre
Developed product based on skim milk with addition of oat giving a high fiber content to the product
Other: Product 4: Skim milk + oat, low fibre
Developed product based on skim milk with addition of oat giving a lower fiber content to the product

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 glycaemia capillary
Time Frame: 0-120 min after consumption
Primary outcome is the difference in the two-hour incremental area under the curve (iAUC (0 - 120 min)) for capillary blood glucose between product 1-4 and the bread reference.
0-120 min after consumption

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 glycaemia intravenous
Time Frame: 0-120 min
The difference in the two-hour iAUC (0 - 120 min) for intravenous blood glucose between product 1-4 and the bread reference.
0-120 min
Postprandial Cmax capillary glucose
Time Frame: 0-180 min
The difference in the three-hour Cmax (0 - 180 min) of capillary blood glucose between product 1-4 and the bread reference.
0-180 min
Postprandial Cmax venous glucose
Time Frame: 0-180 min
The difference in the three-hour Cmax (0 - 180 min) of intravenous blood glucose between product 1-4 and the bread reference.
0-180 min
Postprandial glycaemia capillary
Time Frame: 0-180 min
The difference in the three-hour iAUC (0 - 180 min) of capillary blood glucose between product 1-4 and the bread reference.
0-180 min
Postprandial glycaemia venous
Time Frame: 0-180 min
The difference in the three-hour iAUC (0 - 180 min) of intravenous blood glucose between product 1-4 and the bread reference.
0-180 min
Postprandial glycaemia capillary
Time Frame: 0-60 min
The difference in the one-hour iAUC (0 - 60 min) of capillary blood glucose between product 1-4 and the bread reference.
0-60 min
Postprandial glycaemia venous
Time Frame: 0-60 min
The difference in the one-hour iAUC (0 - 60 min) of intravenous blood glucose between product 1-4 and the bread reference.
0-60 min
Postprandial glycaemia Tmax capillary
Time Frame: 0-180 min
The difference in the Tmax (the time to maximum concentration) of capillary blood glucose between product 1-4 and the bread reference.
0-180 min
Postprandial glycaemia Tmax venous
Time Frame: 0-180 min
The difference in the Tmax of intravenous blood glucose between product 1-4 and the bread reference.
0-180 min
Postprandial insulinaemia
Time Frame: 0-180 min
The difference in the three-hour iAUC (0 - 180 min) of intravenous blood insulin between product 1-4 and the bread reference.
0-180 min
Postprandial insulinaemia
Time Frame: 0-120 min
The difference in the two-hour iAUC (0 - 120 min) of intravenous blood insulin between product 1-4 and the bread reference.
0-120 min
Postprandial insulinaemia
Time Frame: 0-60 min
The difference in the one-hour iAUC (0 - 60 min) of intravenous blood insulin between product 1-4 and the bread reference.
0-60 min
Postprandial insulinaemia Cmax
Time Frame: 0-180 min
The difference in the three-hour Cmax (0 - 180 min) of intravenous blood insulin between product 1-4 and the bread reference.
0-180 min
Postprandial insulinaemia Tmax
Time Frame: 0-180 min
The difference in the Tmax of intravenous blood insulin between product 1-4 and the bread reference.
0-180 min
Postprandial GLP-1 bread reference
Time Frame: 0-60 min
The difference in the one-hour iAUC (0 - 60 min) of intravenous blood GLP-1 between product 1-4 and the bread reference.
0-60 min
Postprandial GLP-1, yoghurt control
Time Frame: 0-60 min
The difference in the one-hour iAUC (0 - 60 min) of intravenous blood GLP-1 between products 2-4 and product 1.
0-60 min
Postprandial GLP-1 Cmax bread reference
Time Frame: 0-60 min
The difference in the one-hour Cmax (0 - 60 min) of intravenous blood GLP-1 between product 1-4 and the bread reference.
0-60 min
Postprandial GLP-1 Cmax yoghurt control
Time Frame: 0-60 min
The difference in the one-hour Cmax (0 - 60 min) of intravenous blood GLP-1 between products 2-4 and product 1.
0-60 min

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.
October 4, 2018

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.
March 5, 2019

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.
March 5, 2019

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).
October 24, 2018

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.
October 25, 2018

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.
October 29, 2018

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, 2019

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.
July 2, 2019

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.
October 1, 2018

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.
  • TR1801

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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