Diabete Type 2NCT05276128
Effects of Plant Based Lipids on Glucose Regulation and Cognitive Variables
A study testing lipids in people with Diabete Type 2 and Obesity, run by Lund University at 2 sites in Sweden.
Trial summary
The overall goal is to increase the knowledge that 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
- Diabete Type 2, Obesity
- What is being tested?
- lipids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesSweden
- Study dates
- 20 Mar 2022to 27 Apr 2022
- 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 subjects
- Between 20 and 40 years old
- Body mass index between 19-28 kg / m2),
- Consuming a non-vegetarian diet generally in line with the Nordic nutrition recommendations.
Who cannot join
- Fasting blood glucose concentration >6.1 mmol/L
- Known metabolic or gastrointestinal disorder (eg diabetes, high cholesterol, high blood pressure, IBS), or other disease that may affect the study results.
- Regular medication, except for long-term and stable medication for the lack or reduced production of thyroid hormone (eg Levaxin).
- Antibiotics or probiotics for at least four weeks before the start of the study,
- The use of tobacco products
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Anne Nilsson
Lund, Välj..., 22100
The Human Trial Facility, Food Technology engineering and Nutrition, Lund University
Lund, Välj..., 22100
About this study
Official title: Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic- and Cognitive Test Variables
The overall goal is to increase the knowledge that 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 acute postprandial glucose regulation of plant based lipids. Due to the tight connection between cardiometabolic health and cognitive functions, a secondary issue is to investigate effects of test foods on cognitive test variables and mood parameters.
- Conditions
- Diabete Type 2, Obesity
- Being tested
- lipids
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipidsDietary supplement
Investigations of dose-response effects of 3 different doses of an bioactive plant based lipid consumed at breakfast, after overnight fasting. Total amounts of lipids in each test portion are 15g, and the lower doses are supplemented with a control lipid to sum upp to 15 g total lipids. A control product with15g control lipids and without active lipids is also included. The lipids are supplemented to a white wheat bread, corresponding to 50 g available starch. A White wheat bread portion without lipid supplementation is included as a well studied reference product.
| Study group | Role | What they receive |
|---|---|---|
| WWB Reference | Other | White wheat bread (WWB) without lipid supplements. The effects of this high glycaemic product on postprandial glucose and insulin responses are well studied. Receives: Dietary Supplement: lipids |
| WWB 5g active lipids | Experimental | WWB supplemented with 5 g active lipids, and 10 g control lipids Receives: Dietary Supplement: lipids |
| WWB 10g active lipids | Experimental | WWB supplemented with 10g active lipids, and 5 g control lipids Receives: Dietary Supplement: lipids |
| WWB 15g active lipids | Experimental | WWB supplemented with 15g active lipids, and 0 g control lipids Receives: Dietary Supplement: lipids |
| WWB 15 g control lipids | Active comparator | WWB supplemented with 15g control lipids Receives: Dietary Supplement: lipids |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose tolerance
Postprandial blood glucose responses
Measured: 3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Secondary outcomes (3)
Insulin responses
Postprandial insulin responses
Measured: 3 hours. Fasting (time =0 minutes), 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Mood variables
Registration of subjective mood ratings (valence and activity) on 0-100 mm Visual Analogue Scales (VAS) at fasting and thereafter every hour until 180 min. Extremes of the sensations of the variables is at the two ends of the scales, i.e. 0 mm relates to the extrem of low senations sensations and 100 mm correspond to the highest sensation of the variables.
Measured: 60 minutes after start of test product, after 120 minutes and after 180 minutes
Appetite sensations
Subjective sensations of hunger, satiety, and desire to eat are registered on 0-100 mm VAS scales. Extremes of the sensations of the variables is at the two ends of the scales, i.e. 0 mm relates to the extrem of low senations sensations and 100 mm correspond to the highest sensation of the variables.
Measured: 3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start20 Mar 2022
- Primary completion27 Apr 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies 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
- 17 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
- NCT05276128
- Sponsor's protocol ID
- 2018/658
- Status last verified
- Apr 2022
- First submitted
- 2 Mar 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make Individual Participant Data (IPD) and related data dictionaries available. The data will be published in a scientific journal as supplementary material simultaneously as the study results. The test persons names are coded and no individual participant can be identified.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic- and Cognitive Test Variables
- ClinicalTrials.gov ID
- NCT05276128
- Acronym / sponsor ID
- 2018/658
- Conditions
- Diabete Type 2, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 11 Mar 2022 (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 is to increase the knowledge that 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 acute postprandial glucose regulation of plant based lipids. Due to the tight connection between cardiometabolic health and cognitive functions, a secondary issue is to investigate effects of test foods on cognitive test variables and mood parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| WWB Reference | Other | Dietary Supplement: lipidsWhite wheat bread (WWB) without lipid supplements. The effects of this high glycaemic product on postprandial glucose and insulin responses are well studied. |
| WWB 5g active lipids | Experimental | Dietary Supplement: lipidsWWB supplemented with 5 g active lipids, and 10 g control lipids |
| WWB 10g active lipids | Experimental | Dietary Supplement: lipidsWWB supplemented with 10g active lipids, and 5 g control lipids |
| WWB 15g active lipids | Experimental | Dietary Supplement: lipidsWWB supplemented with 15g active lipids, and 0 g control lipids |
| WWB 15 g control lipids | Active comparator | Dietary Supplement: lipidsWWB supplemented with 15g control lipids |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Apparently healthy subjects
- Between 20 and 40 years old
- Body mass index between 19-28 kg / m2),
- Consuming a non-vegetarian diet generally in line with the Nordic nutrition recommendations.
Key exclusion criteria (5 listed)
- Fasting blood glucose concentration >6.1 mmol/L
- Known metabolic or gastrointestinal disorder (eg diabetes, high cholesterol, high blood pressure, IBS), or other disease that may affect the study results.
- Regular medication, except for long-term and stable medication for the lack or reduced production of thyroid hormone (eg Levaxin).
- Antibiotics or probiotics for at least four weeks before the start of the study,
- The use of tobacco products
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 |
|---|---|---|
| lipidsInvestigations of dose-response effects of 3 different doses of an bioactive plant based lipid consumed at breakfast, after overnight fasting. Total amounts of lipids in each test portion are 15g, and the lower doses are supplemented with a control lipid to sum upp to 15 g total lipids. A control product with15g control lipids and without active lipids is also included. The lipids are supplemented to a white wheat bread, corresponding to 50 g available starch. A White wheat bread portion without lipid supplementation is included as a well studied reference product. | Dietary supplement | WWB 10g active lipids, WWB 15 g control lipids, WWB 15g active lipids, WWB 5g active lipids, WWB Reference |
Primary outcome
glucose tolerance
Time frame: 3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Postprandial blood glucose responses
3 secondary outcomes
Insulin responses
Time frame: 3 hours. Fasting (time =0 minutes), 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Mood variables
Time frame: 60 minutes after start of test product, after 120 minutes and after 180 minutes
Appetite sensations
Time frame: 3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 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 28 Apr 2022.
- Individual participant dataSharing planned: Yes. There is a plan to make Individual Participant Data (IPD) and related data dictionaries available. The data will be published in a scientific journal as supplementary material simultaneously as the study results. The test persons names are coded and no individual participant can be identified.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lipids in people with Diabete Type 2 and Obesity, run by Lund University at 2 sites 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 5 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 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
glucose tolerance (time frame: 3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 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 28 Apr 2022.