Postprandial Glucose RegulationNCT03830736
Health Effects of Oats and Oat Bioactive in Human
A study testing Oat Beverage 1, Oat Beverage 2 and Oat Beverage 3 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?
- Oat Beverage 1, Oat Beverage 2 and Oat Beverage 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 18 Feb 2019to 30 Dec 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
- healthy adults
- BMI 18,5 - 25
- 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: Effects of Oat and Oat Components on Cardiometabolic- and Cognitive Test Variables
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
- Oat Beverage 1, Oat Beverage 2, Oat Beverage 3, Oat Beverage 4, Control product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oat Beverage 1Combination product
Oat based beverage with added different concentration of extracted oat component.
Oat Beverage 2Combination product
Oat based beverage with added different concentration of extracted oat component.
Oat Beverage 3Combination product
Oat based beverage with added different concentration of extracted oat component.
Oat Beverage 4Combination product
Oat based beverage with added different concentration of extracted oat component.
Control productCombination product
Glucose based beverage without added test components is used as control product
| Study group | Role | What they receive |
|---|---|---|
| Control product | Placebo comparator | A glucose solution (glucose and water) based on 42 gram carbohydrates. Receives: Combination Product: Control product |
| Oat Beverage 1 | Experimental | The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning. Receives: Combination Product: Oat Beverage 1 |
| Oat Beverage 2 | Experimental | The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning. Receives: Combination Product: Oat Beverage 2 |
| Oat Beverage 3 | Experimental | The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning. Receives: Combination Product: Oat Beverage 3 |
| Oat Beverage 4 | Experimental | The test product is an oat based beverage. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning. Receives: Combination Product: Oat Beverage 4 |
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 (5)
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)
IL (interleukin)-6
Inflammatory markers in blood
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- 1beta
Inflammatory markers in blood
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 posted5 Feb 2019
- Study start18 Feb 2019
- Primary completion30 May 2019
- Study completion30 Dec 2019
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
- Model description
- a randomized blinded cross-over study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Foundation for Strategic Research
- Responsible party
- Principal investigator, Anne Nilsson, Lund University
- Investigators
- Anne Nilsson, Study chair, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830736
- Sponsor's protocol ID
- Protokoll 2018/8
- Status last verified
- Apr 2020
- First submitted
- 30 Jan 2019
- Last updated
- 1 May 2020
- 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 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oat and Oat Components on Cardiometabolic- and Cognitive Test Variables
- ClinicalTrials.gov ID
- NCT03830736
- Acronym / sponsor ID
- Protokoll 2018/8
- Conditions
- Postprandial Glucose Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Swedish Foundation for Strategic Research
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 5 Feb 2019 (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
- 5
- Model description
- a randomized blinded cross-over study
| Arm | Type | Receives |
|---|---|---|
| Control product | Placebo comparator | Combination Product: Control productA glucose solution (glucose and water) based on 42 gram carbohydrates. |
| Oat Beverage 1 | Experimental | Combination Product: Oat Beverage 1The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning. |
| Oat Beverage 2 | Experimental | Combination Product: Oat Beverage 2The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning. |
| Oat Beverage 3 | Experimental | Combination Product: Oat Beverage 3The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning. |
| Oat Beverage 4 | Experimental | Combination Product: Oat Beverage 4The test product is an oat based beverage. The test portion is based on 42 gram available carbohydrates and 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 - 25
- 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 |
|---|---|---|
| Oat Beverage 1Oat based beverage with added different concentration of extracted oat component. | Combination product | Oat Beverage 1 |
| Oat Beverage 2Oat based beverage with added different concentration of extracted oat component. | Combination product | Oat Beverage 2 |
| Oat Beverage 3Oat based beverage with added different concentration of extracted oat component. | Combination product | Oat Beverage 3 |
| Oat Beverage 4Oat based beverage with added different concentration of extracted oat component. | Combination product | Oat Beverage 4 |
| Control productGlucose based beverage without added test components is used as control product | Combination product | Control product |
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.
5 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)
IL (interleukin)-6
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- 1beta
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 1 May 2020.
- Individual participant dataSharing planned: No
Related trials for Postprandial Glucose Regulation
Recruiting
Effects of Wheat Flour Milling Method on Glycemic Response and Gastrointestinal Symptoms
Gastrointestinal Irritation, Nutrition, Healthy
Not yet recruiting
The Impact of a Daily Dietary Supplement on Glycemic Control in Individuals With Overweight or Obesity
Glycemic Control, Appetite Regulation
Recruiting
Effect of SugarLock® Peanut Skin Extract on Postprandial Blood Glucose Control
Blood Sugar (Glucose) Control, Postprandial Glucose
Recruiting
Effects of GLP-1 Formula on GLP-1 and Glucose Regulation
Overweight
Recruiting
POTS-FLOW: Interplay Between Gut Hormones and Autonomic Postprandial Blood Flow Regulation in Patients With POTS
Postural Orthostatic Tachycardia Syndrome (POTS), Healthy
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 study chair
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oat Beverage 1, Oat Beverage 2 and Oat Beverage 3 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 1 May 2020. 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 1 May 2020.