Healthy SubjectsNCT05844085
Effects of Plant-based Polar Lipids on Acute and Second Meal Glucose Tolerance and Appetite Sensations
A study testing Non-polar lipids, No lipids and Polar lipids low in people with Healthy Subjects and Diet Intervention, run by Lund University at 1 site in Sweden.
Trial summary
The overall goal of the project is to increase 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Diet Intervention
- What is being tested?
- Non-polar lipids, No lipids and Polar lipids low
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 5 May 2023to 6 Jun 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
- 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
- CVD
- Metabolic diseases
- Inflammatory bowel diseases.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
The Human Trial Facility, Food Technology, Engineering and Nutrition, LTH, Lund University
Lund, Välj..., 22100
About this study
Official title: Effects of Oat and Oat Components on Cardiometabolic- and Cognitive Test Variables
The overall goal of the project is to increase 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 is to evaluate effects on cardiometabolic test markers of bioactive compounds in healthy humans. Previously the investigators reported beneficial effects of oat polar lipids on cardiometabolic risk markers. In this study the effects previously observed will be compared with cardiometabolic effects of another plant based lipid.
- Conditions
- Healthy Subjects, Diet Intervention
- Being tested
- Non-polar lipids, No lipids, Polar lipids low, Polar lipids high
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-polar lipidsOther
The shame comparator lipid intervention product contains no polar lipids. The lipids are mixed with a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. The total amounts of lipids are15g, and the total amounts of available carbohydrates are 50 g.
No lipidsOther
The placebo comparator contains no added lipids. The product contains a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. The total amounts of available carbohydrates are 50 g.
Polar lipids lowDietary supplement
The experimental intervention product contains 7,5 g plant based lipids polar lipids and 7.5 g plant based lipids non polarlipids. The lipids are mixed with a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. TThe total amounts of available carbohydrates are 50 g.
Polar lipids highDietary supplement
The experimental intervention product contains15 g plant based polar lipids. The lipids are mixed with a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. The total amounts of available carbohydrates are 50 g.
| Study group | Role | What they receive |
|---|---|---|
| Non-polar lipids | Sham comparator | A food product containing 15 g plant-based non-polar lipids. The fat is consumed blended with a carbohydrate source containing 50 g available carbohydrates. Receives: Other: Non-polar lipids |
| No Lipids | Placebo comparator | Reference product. A carbohydrate source containing 50 g available carbohydrates. Receives: Other: No lipids |
| Polar Lipids low | Experimental | A food product containing 15 g plant-based lipids, of which 50% is polar lipids and 50% is non-polar lipids.The fat is consumed blended with a carbohydrate source containing 50 g available carbohydrates. Receives: Dietary Supplement: Polar lipids low |
| Polar Lipids high | Experimental | A food product containing 15 g plant-based lipids, of which 100 % is polar lipids. The fat is consumed blended with a carbohydrate source containing 50 g available carbohydrates. Receives: Dietary Supplement: Polar lipids high |
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 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 (3)
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 posted6 May 2023
- Study start5 May 2023
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Randomized, controlled, crossover trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Nilsson, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844085
- Sponsor's protocol ID
- Prot.2018/8-Dnr.2018/658
- Status last verified
- Jun 2023
- First submitted
- 4 Apr 2023
- Last updated
- 8 Jun 2023
- 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 Jun 2023. 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
- NCT05844085
- Acronym / sponsor ID
- Prot.2018/8-Dnr.2018/658
- Conditions
- Healthy Subjects, Diet Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 6 May 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.
The overall goal of the project is to increase 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 is to evaluate effects on cardiometabolic test markers of bioactive compounds in healthy humans. Previously the investigators reported beneficial effects of oat polar lipids on cardiometabolic risk markers. In this study the effects previously observed will be compared with cardiometabolic effects of another plant based lipid.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Randomized, controlled, crossover trial
| Arm | Type | Receives |
|---|---|---|
| Non-polar lipids | Sham comparator | Other: Non-polar lipidsA food product containing 15 g plant-based non-polar lipids. The fat is consumed blended with a carbohydrate source containing 50 g available carbohydrates. |
| No Lipids | Placebo comparator | Other: No lipidsReference product. A carbohydrate source containing 50 g available carbohydrates. |
| Polar Lipids low | Experimental | Dietary Supplement: Polar lipids lowA food product containing 15 g plant-based lipids, of which 50% is polar lipids and 50% is non-polar lipids.The fat is consumed blended with a carbohydrate source containing 50 g available carbohydrates. |
| Polar Lipids high | Experimental | Dietary Supplement: Polar lipids highA food product containing 15 g plant-based lipids, of which 100 % is polar lipids. The fat is consumed blended with a carbohydrate source containing 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 |
|---|---|---|
| Non-polar lipidsThe shame comparator lipid intervention product contains no polar lipids. The lipids are mixed with a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. The total amounts of lipids are15g, and the total amounts of available carbohydrates are 50 g. | Other | Non-polar lipids |
| No lipidsThe placebo comparator contains no added lipids. The product contains a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. The total amounts of available carbohydrates are 50 g. | Other | No Lipids |
| Polar lipids lowThe experimental intervention product contains 7,5 g plant based lipids polar lipids and 7.5 g plant based lipids non polarlipids. The lipids are mixed with a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. TThe total amounts of available carbohydrates are 50 g. | Dietary supplement | Polar Lipids low |
| Polar lipids highThe experimental intervention product contains15 g plant based polar lipids. The lipids are mixed with a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. The total amounts of available carbohydrates are 50 g. | Dietary supplement | Polar Lipids high |
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 are incremental areas under the curve after the test breakfast and after the standardised lunch
3 secondary outcomes
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 8 Jun 2023.
- 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 Non-polar lipids, No lipids and Polar lipids low in people with Healthy Subjects and Diet Intervention, 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 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 8 Jun 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 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 8 Jun 2023.