HealthyNCT05801653
Health Effects of Oat Bioactives (Betaglucan) in Human
A study testing Effects of Oat and Oat Components on Cardiometabolic risk variables in people with Healthy, 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
- Healthy
- 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
- 8 Mar 2023to 10 Aug 2023
- 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 Kg/m2 Non smokers Consuming a non-vegetarian diet that follows the Nordic diet recommendation.
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.
- 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, Skåne County, 22100
About this study
Official title: Health Effects of Oat and Oat Bioactives in Human
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
- Healthy
- 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 variablesDietary supplement
Oat and oat bioactive components consumed as breakfast meal.
| Study group | Role | What they receive |
|---|---|---|
| Oat meal 1 | Experimental | The test portion is based on 30 gram available carbohydrates with added x amount oat betaglucan. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning Receives: Dietary Supplement: Effects of Oat and Oat Components on Cardiometabolic risk variables |
| Oat meal 2 | Experimental | The test portion is based on 30 gram available carbohydrates with added y amount of oat betaglucan. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning Receives: Dietary Supplement: Effects of Oat and Oat Components on Cardiometabolic risk variables |
| Oat meal 3 | Experimental | The test portion is based on 30 gram available carbohydrates with added z amount of oat betaglucan. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning Receives: Dietary Supplement: Effects of Oat and Oat Components on Cardiometabolic risk variables |
| Reference | Placebo comparator | The test portion is based on 30 gram available carbohydrates without added oat betaglucan. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning Receives: Dietary Supplement: 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: Time Frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Secondary outcomes (1)
Serum insulin
Acute effects of postprandial serum insulin concentrations (incremental area under the curve) after intake of the test products.
Measured: Time Frame: 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 posted6 Apr 2023
- Study start8 Mar 2023
- Primary completion15 Jun 2023
- Study completion10 Aug 2023
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.
- 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
- Investigators
- Anne Nilsson, Principal investigator, Department of Food Technology, Engineering and Nutrition, Lund Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801653
- Sponsor's protocol ID
- Dnr. 2018/658 (del 4)
- Status last verified
- Oct 2023
- First submitted
- 24 Mar 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Raw data
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of Oat and Oat Bioactives in Human
- ClinicalTrials.gov ID
- NCT05801653
- Acronym / sponsor ID
- Dnr. 2018/658 (del 4)
- Conditions
- Healthy
- 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
- 8 Mar 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 6 Apr 2023 (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 meal 1 | Experimental | Dietary Supplement: Effects of Oat and Oat Components on Cardiometabolic risk variablesThe test portion is based on 30 gram available carbohydrates with added x amount oat betaglucan. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning |
| Oat meal 2 | Experimental | Dietary Supplement: Effects of Oat and Oat Components on Cardiometabolic risk variablesThe test portion is based on 30 gram available carbohydrates with added y amount of oat betaglucan. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning |
| Oat meal 3 | Experimental | Dietary Supplement: Effects of Oat and Oat Components on Cardiometabolic risk variablesThe test portion is based on 30 gram available carbohydrates with added z amount of oat betaglucan. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning |
| Reference | Placebo comparator | Dietary Supplement: Effects of Oat and Oat Components on Cardiometabolic risk variablesThe test portion is based on 30 gram available carbohydrates without added oat betaglucan. 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 (1 listed)
- Healthy adults BMI 18.5 - 28 Kg/m2 Non smokers Consuming a non-vegetarian diet that follows the Nordic diet recommendation.
Key exclusion criteria (3 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.
- 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. | Dietary supplement | Oat meal 1, Oat meal 2, Oat meal 3, Reference |
Primary outcome
Blood glucose regulation
Time frame: 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.
1 secondary outcome
Serum insulin
Time frame: 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 4 Oct 2023.
- Individual participant dataSharing planned: No. Raw data
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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.
Anne Nilsson principal investigator
Department of Food Technology, Engineering and Nutrition, Lund Univesity
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 Healthy, 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 1 inclusion and 3 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 4 Oct 2023. 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: 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 4 Oct 2023.