Postprandial Glucose RegulationNCT04542265
Health Effects of Oat and Oat Bioactive in Human
A study testing Effects of Oat and Oat Components on Cardiometabolic risk variables in people with Postprandial Glucose Regulation, run by Lund University at 1 site in Sweden.
Trial summary
Aim of the study is to investigate health effects of oats and oat derived components, in human intervention studies, with the purpose to build new knowledge for development of cardiometabolic protective foods Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Glucose Regulation
- What is being tested?
- Effects of Oat and Oat Components on Cardiometabolic risk variables
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 28 Aug 2020to 18 Dec 2020
- 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
- healthy adults
- BMI 18,5 - 28
- non smokers
- consuming a non-vegetarian diet that follows the Nordic guidances
Who cannot join
- Fasting blood glucose concentration >6.1 mmol/l
- Known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome), gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies. Further no antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Food Technology, engineering and Nutrition, LTH, Lund University
Lund, 22100
About this study
Official title: Dose Response Effects of Oat Bioactive in Healthy Adults
Aim of the study is to investigate health effects of oats and oat derived components, in human intervention studies, with the purpose to build new knowledge for development of cardiometabolic protective foods
Read the detailed description
The overall goal is to increase the knowledge which can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the primary purpose of this project is to evaluate effects in healthy humans on cardiometabolic test markers of oat and oat based product. The new knowledge will form a base for the development of oat based food products with added health values.
- Conditions
- Postprandial Glucose Regulation
- Being tested
- Effects of Oat and Oat Components on Cardiometabolic risk variables
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effects of Oat and Oat Components on Cardiometabolic risk variablesCombination product
Oat and oat bioactive components consumed as breakfast meal.
| Study group | Role | What they receive |
|---|---|---|
| Oat product 1 | Experimental | The test portion is based on 50 gram available carbohydrates with added vegetable oil A. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning. Receives: Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variables |
| Oat product 2 | Experimental | The test portion is based on 50 gram available carbohydrates with added vegetable oil B. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning. Receives: Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variables |
| Oat product 3 | Experimental | The test portion is based on 50 gram available carbohydrates with added vegetable oil A + vegetable oil B. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning. Receives: Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variables |
| Control Product | Placebo comparator | The test portion is based on 50 gram available carbohydrates without added vegetable oil. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning. Receives: Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose regulation
Postprandial blood glucose regulation (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 5.5 hours after consumption of test products.
Measured: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Secondary outcomes (6)
Serum insulin
Acute effects of postprandial serum insulin concentrations (incremental area under the curve) after intake of the test products.
Measured: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
plasma GLP-1 (glucagon-like peptide-1 )
Gastro-intestinale hormones involved in appetite and metabolic regulation
Measured: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Plasma PYY (peptide tyrosine tyrosine)
Gastro-intestinale hormones involved in appetite and metabolic regulation
Measured: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
IL (interleukin)-6
Inflammatory markers in blood
Measured: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Serum triglycerides
Cardiometabolic risk markers
Measured: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Serum Free Fatty Acids
Cardiometabolic risk markers
Measured: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start28 Aug 2020
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial Glucose RegulationStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Foundation for Strategic Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542265
- Sponsor's protocol ID
- Protokoll 2018/8b
- Status last verified
- Feb 2021
- First submitted
- 4 Sep 2020
- Last updated
- 8 Feb 2021
- 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 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response Effects of Oat Bioactive in Healthy Adults
- ClinicalTrials.gov ID
- NCT04542265
- Acronym / sponsor ID
- Protokoll 2018/8b
- Conditions
- Postprandial Glucose Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Swedish Foundation for Strategic Research
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 9 Sep 2020 (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.
Aim of the study is to investigate health effects of oats and oat derived components, in human intervention studies, with the purpose to build new knowledge for development of cardiometabolic protective foods
Detailed description
The overall goal is to increase the knowledge which can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the primary purpose of this project is to evaluate effects in healthy humans on cardiometabolic test markers of oat and oat based product. The new knowledge will form a base for the development of oat based food products with added health values.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oat product 1 | Experimental | Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variablesThe test portion is based on 50 gram available carbohydrates with added vegetable oil A. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning. |
| Oat product 2 | Experimental | Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variablesThe test portion is based on 50 gram available carbohydrates with added vegetable oil B. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning. |
| Oat product 3 | Experimental | Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variablesThe test portion is based on 50 gram available carbohydrates with added vegetable oil A + vegetable oil B. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning. |
| Control Product | Placebo comparator | Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variablesThe test portion is based on 50 gram available carbohydrates without added vegetable oil. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy adults
- BMI 18,5 - 28
- non smokers
- consuming a non-vegetarian diet that follows the Nordic guidances
Key exclusion criteria (2 listed)
- Fasting blood glucose concentration >6.1 mmol/l
- Known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome), gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies. Further no antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study
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 |
|---|---|---|
| Effects of Oat and Oat Components on Cardiometabolic risk variablesOat and oat bioactive components consumed as breakfast meal. | Combination product | Control Product, Oat product 1, Oat product 2, Oat product 3 |
Primary outcome
Blood glucose regulation
Time frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Postprandial blood glucose regulation (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 5.5 hours after consumption of test products.
6 secondary outcomes
Serum insulin
Time frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
plasma GLP-1 (glucagon-like peptide-1 )
Time frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Plasma PYY (peptide tyrosine tyrosine)
Time frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
IL (interleukin)-6
Time frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Serum triglycerides
Time frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Serum Free Fatty Acids
Time frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
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 8 Feb 2021.
- Individual participant dataSharing planned: No
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 Effects of Oat and Oat Components on Cardiometabolic risk variables in people with Postprandial Glucose Regulation, run by Lund University 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 4 inclusion and 2 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 8 Feb 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?
Blood glucose regulation (time frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)). 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 8 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.