HealthyNCT06148974
Effects of Plant Polar Lipids on Glucose Tolerance
A study testing Polar lipid 1, Polar lipid 2 and Non-polar lipids in people with Healthy, run by Anne Nilsson at 1 site in Sweden.
Trial summary
In this randomized controlled trial, two different plant polar lipids are investigated with respect to their potential to affect acute and second meal glucose tolerance and appetite sensations. The effects are compared with a common non-polar commercial oil. The lipids are consumed spread on a white wheat bread. 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?
- Polar lipid 1, Polar lipid 2 and Non-polar lipids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteSweden
- Study dates
- 6 Dec 2023to 25 Jan 2024
- 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
- Apparently healthy men and women
- non-smokers
- between 20-40 years of age
- BMI between 18,5-30 kg/m2
- No known metabolic disorders or food allergies.
- The test subjects should follow a normal diet in accordance with the Nordic Nutrition Recommendations.
Who cannot join
- Fasting blood glucose ≥6.1 mmol/L
- Use of antibiotics or probiotics in the last three months or during the study period.
- Smoking
- Blood donation during the last two months and during the study.
- Food allergies or food intolerances
- Cardiovascular diseases
- Metabolic diseases
- Inflammatory bowel diseases.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Lund University, dep of Food Technology, Engineering, and Nutrition
Lund, Välj..., 22100
About this study
Official title: Effects of Oat and Oat Components on Cardiometabolic- and Cognitive Test Variables
In this randomized controlled trial, two different plant polar lipids are investigated with respect to their potential to affect acute and second meal glucose tolerance and appetite sensations. The effects are compared with a common non-polar commercial oil. The lipids are consumed spread on a white wheat bread. A white wheat bread without added lipids is included as a control product. The test products are consumed at breakfast, and test variables are investigated in the postprandial period after the test breakfast and also after a second meal standard lunch.
- Conditions
- Healthy
- Being tested
- Polar lipid 1, Polar lipid 2, Non-polar lipids, No lipids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polar lipid 1Dietary supplement
15g plant polar lipids from plant source 1. The lipid supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).
Polar lipid 2Dietary supplement
15g plant polar lipids from plant source 2. The lipid supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).
Non-polar lipidsDietary supplement
15g non-polar plant lipids from plant source 1. The lipids supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).
No lipidsOther
A commercial white wheat flour bread as a source of available carbohydrates (50 g), without added lipids.
| Study group | Role | What they receive |
|---|---|---|
| Polar lipid 1 | Experimental | 15 g Plant polar lip 1 consumed with a white wheat bread including 50 g available carbohydrates Receives: Dietary Supplement: Polar lipid 1 |
| Polar lipid 2 | Experimental | 15 g Plant polar lipids 2 consumed with a white wheat bread including 50 g available carbohydrates Receives: Dietary Supplement: Polar lipid 2 |
| non-polar lipids | Active comparator | 15 g commonly consumed non-polar lipids consumed with a white wheat bread including 50 g available carbohydrates Receives: Dietary Supplement: Non-polar lipids |
| no lipids | Placebo comparator | A white wheat bread including 50 g available carbohydrates Receives: Other: No lipids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose concentration (glucose tolerance)
Test products will be consumed at breakfast. Blood glucose will be determined repeatedly after the breakfast and also following a standardised lunch. The primary outcome measures for glucose concentrations are incremental areas under the curve after the test breakfast and after the standardised lunch
Measured: 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.
Secondary outcomes (4)
Serum insulin concentrations
Test products will be consumed at breakfast. Insulin will be determined repeatedly after the breakfast and also following a standardised lunch. The primary outcome measures for insulin are incremental areas under the curve after the test breakfast and after the standardised lunch
Measured: 5.5 hours. Fasting (time =0), 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.
Subjective hunger sensations
Test products will be consumed at breakfast. Subjective appetite variables will be determined repeatedly after the breakfast and also following a standardised lunch. The secondary outcome measures are areas under the curve after the test breakfast and after the standardised lunch. Subjective appetite variables will be determined using a 100 mm Visual Analogue Scale (VAS).
Measured: 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.
Subjective satiety sensations
Test products will be consumed at breakfast. Subjective appetite variables will be determined repeatedly after the breakfast and also following a standardised lunch. The secondary outcome measures are areas under the curve after the test breakfast and after the standardised lunch. Subjective appetite variables will be determined using a 100 mm Visual Analogue Scale (VAS).
Measured: 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.
Subjective sensations of desire to eat
Test products will be consumed at breakfast. Subjective appetite variables will be determined repeatedly after the breakfast and also following a standardised lunch. The secondary outcome measures are areas under the curve after the test breakfast and after the standardised lunch. Subjective appetite variables will be determined using a 100 mm Visual Analogue Scale (VAS).
Measured: 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start6 Dec 2023
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne Nilsson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anne Nilsson, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148974
- Sponsor's protocol ID
- Prot.2018/8-23
- Status last verified
- Jan 2024
- First submitted
- 20 Nov 2023
- Last updated
- 26 Jan 2024
- Results posted
- 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 26 Jan 2024. 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
- NCT06148974
- Acronym / sponsor ID
- Prot.2018/8-23
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Anne NilssonUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 28 Nov 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.
In this randomized controlled trial, two different plant polar lipids are investigated with respect to their potential to affect acute and second meal glucose tolerance and appetite sensations. The effects are compared with a common non-polar commercial oil. The lipids are consumed spread on a white wheat bread. A white wheat bread without added lipids is included as a control product. The test products are consumed at breakfast, and test variables are investigated in the postprandial period after the test breakfast and also after a second meal standard lunch.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Polar lipid 1 | Experimental | Dietary Supplement: Polar lipid 115 g Plant polar lip 1 consumed with a white wheat bread including 50 g available carbohydrates |
| Polar lipid 2 | Experimental | Dietary Supplement: Polar lipid 215 g Plant polar lipids 2 consumed with a white wheat bread including 50 g available carbohydrates |
| non-polar lipids | Active comparator | Dietary Supplement: Non-polar lipids15 g commonly consumed non-polar lipids consumed with a white wheat bread including 50 g available carbohydrates |
| no lipids | Placebo comparator | Other: No lipidsA white wheat bread including 50 g available carbohydrates |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Apparently healthy men and women
- non-smokers
- between 20-40 years of age
- BMI between 18,5-30 kg/m2
- No known metabolic disorders or food allergies.
Key exclusion criteria (8 listed)
- Fasting blood glucose ≥6.1 mmol/L
- Use of antibiotics or probiotics in the last three months or during the study period.
- Smoking
- Blood donation during the last two months and during the study.
- Food allergies or food intolerances
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 |
|---|---|---|
| Polar lipid 115g plant polar lipids from plant source 1. The lipid supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g). | Dietary supplement | Polar lipid 1 |
| Polar lipid 215g plant polar lipids from plant source 2. The lipid supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g). | Dietary supplement | Polar lipid 2 |
| Non-polar lipids15g non-polar plant lipids from plant source 1. The lipids supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g). | Dietary supplement | non-polar lipids |
| No lipidsA commercial white wheat flour bread as a source of available carbohydrates (50 g), without added lipids. | Other | no lipids |
Primary outcome
Blood glucose concentration (glucose tolerance)
Time frame: 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.
Test products will be consumed at breakfast. Blood glucose will be determined repeatedly after the breakfast and also following a standardised lunch. The primary outcome measures for glucose concentrations are incremental areas under the curve after the test breakfast and after the standardised lunch
4 secondary outcomes
Serum insulin concentrations
Time frame: 5.5 hours. Fasting (time =0), 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.
Subjective hunger sensations
Time frame: 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.
Subjective satiety sensations
Time frame: 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.
Subjective sensations of desire to eat
Time frame: 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.
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 26 Jan 2024.
- 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 Polar lipid 1, Polar lipid 2 and Non-polar lipids in people with Healthy, run by Anne Nilsson 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 8 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 26 Jan 2024. 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 concentration (glucose tolerance) (time frame: 5.5 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 225 minutes, 240 minutes, 255 minutes, 270 minutes, 300 minutes, and 330 minutes.). 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 26 Jan 2024.