HealthyNCT03722641
Evaluation of Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products
A study testing Bread reference, Product 1: Milk and Product 2: Full fat milk + oat in people with Healthy, run by Aventure AB at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Bread reference, Product 1: Milk and Product 2: Full fat milk + oat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 4 Oct 2018to 5 Mar 2019
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female 20 to 40 years of age
- BMI 20-27 (±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 (at or above 6.1 mmol/L at fasting on visit 2, 3, 4 or 5)
- Elevated fasting insulin (above 25 mIE/L)
- 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 SI
- 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.
- Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
Show all 18Show fewer
- Use of antibiotics within 2 weeks of enrollment
- 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 lactose or 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 SI
- 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 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Bread reference, Product 1: Milk, Product 2: Full fat milk + oat, Product 3: Skim milk + oat, high fibre, Product 4: Skim milk + oat, low fibre
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bread referenceOther
Commercially available white wheat bread
Product 1: MilkOther
Developed reference product based on milk
Product 2: Full fat milk + oatOther
Developed product based on full fat milk with addition of oat
Product 3: Skim milk + oat, high fibreOther
Developed product based on skim milk with addition of oat giving a high fiber content to the product
Product 4: Skim milk + oat, low fibreOther
Developed product based on skim milk with addition of oat giving a lower fiber content to the product
| Study group | Role | What they receive |
|---|---|---|
| Bread reference | Placebo comparator | A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread. Receives: Other: Bread reference; Other: Product 1: Milk; Other: Product 2: Full fat milk + oat; Other: Product 3: Skim milk + oat, high fibre; Other: Product 4: Skim milk + oat, low fibre |
| Product 1: Milk | Experimental | A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on milk. Receives: Other: Bread reference; Other: Product 1: Milk; Other: Product 2: Full fat milk + oat; Other: Product 3: Skim milk + oat, high fibre; Other: Product 4: Skim milk + oat, low fibre |
| Product 2: Full fat milk + oat | Experimental | 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. Receives: Other: Bread reference; Other: Product 1: Milk; Other: Product 2: Full fat milk + oat; Other: Product 3: Skim milk + oat, high fibre; Other: Product 4: Skim milk + oat, low fibre |
| Product 3: Skim milk + oat, high fibre | Experimental | 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. Receives: Other: Bread reference; Other: Product 1: Milk; Other: Product 2: Full fat milk + oat; Other: Product 3: Skim milk + oat, high fibre; Other: Product 4: Skim milk + oat, low fibre |
| Product 4: Skim milk + oat, low fibre | Experimental | 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. Receives: Other: Bread reference; Other: Product 1: Milk; Other: Product 2: Full fat milk + oat; Other: Product 3: Skim milk + oat, high fibre; Other: Product 4: Skim milk + oat, low fibre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycaemia capillary
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.
Measured: 0-120 min after consumption
Secondary outcomes (18)
Postprandial glycaemia intravenous
The difference in the two-hour iAUC (0 - 120 min) for intravenous blood glucose between product 1-4 and the bread reference.
Measured: 0-120 min
Postprandial Cmax capillary glucose
The difference in the three-hour Cmax (0 - 180 min) of capillary blood glucose between product 1-4 and the bread reference.
Measured: 0-180 min
Postprandial Cmax venous glucose
The difference in the three-hour Cmax (0 - 180 min) of intravenous blood glucose between product 1-4 and the bread reference.
Measured: 0-180 min
Postprandial glycaemia capillary
The difference in the three-hour iAUC (0 - 180 min) of capillary blood glucose between product 1-4 and the bread reference.
Measured: 0-180 min
Postprandial glycaemia venous
The difference in the three-hour iAUC (0 - 180 min) of intravenous blood glucose between product 1-4 and the bread reference.
Measured: 0-180 min
Postprandial glycaemia capillary
The difference in the one-hour iAUC (0 - 60 min) of capillary blood glucose between product 1-4 and the bread reference.
Measured: 0-60 min
Postprandial glycaemia venous
The difference in the one-hour iAUC (0 - 60 min) of intravenous blood glucose between product 1-4 and the bread reference.
Measured: 0-60 min
Postprandial glycaemia Tmax capillary
The difference in the Tmax (the time to maximum concentration) of capillary blood glucose between product 1-4 and the bread reference.
Measured: 0-180 min
Postprandial glycaemia Tmax venous
The difference in the Tmax of intravenous blood glucose between product 1-4 and the bread reference.
Measured: 0-180 min
Postprandial insulinaemia
The difference in the three-hour iAUC (0 - 180 min) of intravenous blood insulin between product 1-4 and the bread reference.
Measured: 0-180 min
Postprandial insulinaemia
The difference in the two-hour iAUC (0 - 120 min) of intravenous blood insulin between product 1-4 and the bread reference.
Measured: 0-120 min
Postprandial insulinaemia
The difference in the one-hour iAUC (0 - 60 min) of intravenous blood insulin between product 1-4 and the bread reference.
Measured: 0-60 min
Postprandial insulinaemia Cmax
The difference in the three-hour Cmax (0 - 180 min) of intravenous blood insulin between product 1-4 and the bread reference.
Measured: 0-180 min
Postprandial insulinaemia Tmax
The difference in the Tmax of intravenous blood insulin between product 1-4 and the bread reference.
Measured: 0-180 min
Postprandial GLP-1 bread reference
The difference in the one-hour iAUC (0 - 60 min) of intravenous blood GLP-1 between product 1-4 and the bread reference.
Measured: 0-60 min
Postprandial GLP-1, yoghurt control
The difference in the one-hour iAUC (0 - 60 min) of intravenous blood GLP-1 between products 2-4 and product 1.
Measured: 0-60 min
Postprandial GLP-1 Cmax bread reference
The difference in the one-hour Cmax (0 - 60 min) of intravenous blood GLP-1 between product 1-4 and the bread reference.
Measured: 0-60 min
Postprandial GLP-1 Cmax yoghurt control
The difference in the one-hour Cmax (0 - 60 min) of intravenous blood GLP-1 between products 2-4 and product 1.
Measured: 0-60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start4 Oct 2018
- Primary completion5 Mar 2019
- Study completion5 Mar 2019
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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 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
- NCT03722641
- Sponsor's protocol ID
- TR1801
- Status last verified
- Oct 2018
- First submitted
- 24 Oct 2018
- Last updated
- 5 Jul 2019
- 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 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Crossover Study to Evaluate Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products
- ClinicalTrials.gov ID
- NCT03722641
- Acronym / sponsor ID
- TR1801
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aventure ABIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 5 Mar 2019 (actual)
- First posted
- 29 Oct 2018 (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 objective of this study is to investigate the effect on postprandial glycaemia in a healthy population after intake of milk and oat based products.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Bread reference | Placebo comparator | Other: Bread reference, Other: Product 1: Milk, Other: Product 2: Full fat milk + oat, Other: Product 3: Skim milk + oat, high fibre, Other: Product 4: Skim milk + oat, low fibreA standardized (50 grams carbohydrates) breakfast meal will be provided based on bread. |
| Product 1: Milk | Experimental | Other: Bread reference, Other: Product 1: Milk, Other: Product 2: Full fat milk + oat, Other: Product 3: Skim milk + oat, high fibre, Other: Product 4: Skim milk + oat, low fibreA standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on milk. |
| Product 2: Full fat milk + oat | Experimental | Other: Bread reference, Other: Product 1: Milk, Other: Product 2: Full fat milk + oat, Other: Product 3: Skim milk + oat, high fibre, Other: Product 4: Skim milk + oat, low fibreA 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. |
| Product 3: Skim milk + oat, high fibre | Experimental | Other: Bread reference, Other: Product 1: Milk, Other: Product 2: Full fat milk + oat, Other: Product 3: Skim milk + oat, high fibre, Other: Product 4: Skim milk + oat, low fibreA 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. |
| Product 4: Skim milk + oat, low fibre | Experimental | Other: Bread reference, Other: Product 1: Milk, Other: Product 2: Full fat milk + oat, Other: Product 3: Skim milk + oat, high fibre, Other: Product 4: Skim milk + oat, low fibreA 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female 20 to 40 years of age
- BMI 20-27 (±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 (18 listed)
- Elevated fasting blood glucose (at or above 6.1 mmol/L at fasting on visit 2, 3, 4 or 5)
- Elevated fasting insulin (above 25 mIE/L)
- 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 SI
- 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.
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 |
|---|---|---|
| Bread referenceCommercially available white wheat bread | Other | Bread reference, Product 1: Milk, Product 2: Full fat milk + oat, Product 3: Skim milk + oat, high fibre, Product 4: Skim milk + oat, low fibre |
| Product 1: MilkDeveloped reference product based on milk | Other | Bread reference, Product 1: Milk, Product 2: Full fat milk + oat, Product 3: Skim milk + oat, high fibre, Product 4: Skim milk + oat, low fibre |
| Product 2: Full fat milk + oatDeveloped product based on full fat milk with addition of oat | Other | Bread reference, Product 1: Milk, Product 2: Full fat milk + oat, Product 3: Skim milk + oat, high fibre, Product 4: Skim milk + oat, low fibre |
| Product 3: Skim milk + oat, high fibreDeveloped product based on skim milk with addition of oat giving a high fiber content to the product | Other | Bread reference, Product 1: Milk, Product 2: Full fat milk + oat, Product 3: Skim milk + oat, high fibre, Product 4: Skim milk + oat, low fibre |
| Product 4: Skim milk + oat, low fibreDeveloped product based on skim milk with addition of oat giving a lower fiber content to the product | Other | Bread reference, Product 1: Milk, Product 2: Full fat milk + oat, Product 3: Skim milk + oat, high fibre, Product 4: Skim milk + oat, low fibre |
Primary outcome
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.
18 secondary outcomes
Postprandial glycaemia intravenous
Time frame: 0-120 min
Postprandial Cmax capillary glucose
Time frame: 0-180 min
Postprandial Cmax venous glucose
Time frame: 0-180 min
Postprandial glycaemia capillary
Time frame: 0-180 min
Postprandial glycaemia venous
Time frame: 0-180 min
Postprandial glycaemia capillary
Time frame: 0-60 min
Postprandial glycaemia venous
Time frame: 0-60 min
Postprandial glycaemia Tmax capillary
Time frame: 0-180 min
Postprandial glycaemia Tmax venous
Time frame: 0-180 min
Postprandial insulinaemia
Time frame: 0-180 min
Postprandial insulinaemia
Time frame: 0-120 min
Postprandial insulinaemia
Time frame: 0-60 min
Postprandial insulinaemia Cmax
Time frame: 0-180 min
Postprandial insulinaemia Tmax
Time frame: 0-180 min
Postprandial GLP-1 bread reference
Time frame: 0-60 min
Postprandial GLP-1, yoghurt control
Time frame: 0-60 min
Postprandial GLP-1 Cmax bread reference
Time frame: 0-60 min
Postprandial GLP-1 Cmax yoghurt control
Time frame: 0-60 min
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 2019.
- 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 Bread reference, Product 1: Milk and Product 2: Full fat milk + oat in people with Healthy, 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 2019. 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 glycaemia capillary (time frame: 0-120 min after consumption). 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 2019.