Healthy SubjectsNCT05177172
Effect of Oat Compounds on Postprandial Glucose Response
A study testing High beta glucans, Low beta glucans and Low beta glucans + low polar lipids in people with Healthy Subjects, run by Lund University at 1 site in Sweden.
Trial summary
In this project we will investigate synergistic effects of oat polar lipids and beta glucans on postprandial glucose tolerance 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
- What is being tested?
- High beta glucans, Low beta glucans and Low beta glucans + low polar lipids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2021to 19 Jan 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
- healthy
- BMI 20-28 kg/m2
- Diet which follows the Nordic Nutrition Recommendations (non-vegetarian)
Who cannot join
- fasting glucose > 6.1 mmol/L
- metabolic diseases
- gastrointestinal disease
- chronic and/or psychological disease
- food allergy
- Vegetarian or vegan diets, or other special diets
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Lund University, Food Technology, Engineering and Nutrition
Lund, 22100
About this study
Official title: Synergistic Effect of Oat Beta-glucans and Oat Polar Lipids on Postprandial Glucose Response
In this project we will investigate synergistic effects of oat polar lipids and beta glucans on postprandial glucose tolerance
- Conditions
- Healthy Subjects
- Being tested
- High beta glucans, Low beta glucans, Low beta glucans + low polar lipids, Polar lipids, Control
- Keywords
- Prevention, food, diabetes type 2, postprandial glucose regulation, appetite, oat, polar lipids, obesity, glucose tolerance
- Medical subject headings
- Diabetes Mellitus, Type 2, Gyrate Atrophy, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High beta glucansOther
higher dose betaglucans
Low beta glucansOther
lower dose beta glucans
Low beta glucans + low polar lipidsOther
low dose betaglucans in a combination with low dose of polar lipids
Polar lipidsOther
low dose polar lipids
ControlOther
No beta glucans or polar lipids
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | White wheat flour bread Receives: Other: Control |
| High betaglucans | Experimental | White wheat flour bread included beta glucans with the highest amounts in this study Receives: Other: High beta glucans |
| Low beta glucans | Experimental | White wheat flour bread included beta glucans with the lowest amounts in this study Receives: Other: Low beta glucans |
| Low beta glucans + low polar lipids | Experimental | White wheat flour bread included a combination of the lowest amounts of beta glucans and polar lipids Receives: Other: Low beta glucans + low polar lipids |
| low polar lipids | Experimental | White wheat flour bread included polar lipids Receives: Other: Polar lipids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance
Postprandial glucose concentrations (mmol/L). The incremental area under the curve will be calculated and expressed as mmol*minutes/litre.
Measured: 3 hours. Fasting (time =0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Secondary outcomes (1)
Subjective appetite variables
Postprandial sensation of hunger, satiety, and desire to eat will be determined with a 100 millimeter visual analogue scale (VAS). The left end of the VAS scale represent "not at all" (e.g. hungry) and right end of the scale represented "extremely". One scale for each parameter will be used. The total area under the curve will be calculated, and the results will be expressed as millimeter*minutes.
Measured: 3 hours. Fasting (time =0 minutes), 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 posted4 Jan 2022
- Study start1 Dec 2021
- Primary completion19 Jan 2022
- Study completion19 Jan 2022
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
- Randomised food study in healthy subjects
- 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
- NCT05177172
- Sponsor's protocol ID
- Scanoats
- Status last verified
- Jan 2022
- First submitted
- 1 Dec 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be available after request
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effect of Oat Beta-glucans and Oat Polar Lipids on Postprandial Glucose Response
- ClinicalTrials.gov ID
- NCT05177172
- Acronym / sponsor ID
- Scanoats
- Conditions
- Healthy Subjects
- Keywords
- Prevention, food, diabetes type 2, postprandial glucose regulation, appetite, oat, polar lipids, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 4 Jan 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.
In this project we will investigate synergistic effects of oat polar lipids and beta glucans on postprandial glucose tolerance
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Randomised food study in healthy subjects
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: ControlWhite wheat flour bread |
| High betaglucans | Experimental | Other: High beta glucansWhite wheat flour bread included beta glucans with the highest amounts in this study |
| Low beta glucans | Experimental | Other: Low beta glucansWhite wheat flour bread included beta glucans with the lowest amounts in this study |
| Low beta glucans + low polar lipids | Experimental | Other: Low beta glucans + low polar lipidsWhite wheat flour bread included a combination of the lowest amounts of beta glucans and polar lipids |
| low polar lipids | Experimental | Other: Polar lipidsWhite wheat flour bread included polar lipids |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy
- BMI 20-28 kg/m2
- Diet which follows the Nordic Nutrition Recommendations (non-vegetarian)
Key exclusion criteria (6 listed)
- fasting glucose > 6.1 mmol/L
- metabolic diseases
- gastrointestinal disease
- chronic and/or psychological disease
- food allergy
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 |
|---|---|---|
| High beta glucanshigher dose betaglucans | Other | High betaglucans |
| Low beta glucanslower dose beta glucans | Other | Low beta glucans |
| Low beta glucans + low polar lipidslow dose betaglucans in a combination with low dose of polar lipids | Other | Low beta glucans + low polar lipids |
| Polar lipidslow dose polar lipids | Other | low polar lipids |
| ControlNo beta glucans or polar lipids | Other | Control |
Primary outcome
Glucose tolerance
Time frame: 3 hours. Fasting (time =0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Postprandial glucose concentrations (mmol/L). The incremental area under the curve will be calculated and expressed as mmol*minutes/litre.
1 secondary outcome
Subjective appetite variables
Time frame: 3 hours. Fasting (time =0 minutes), 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 21 Jan 2022.
- Individual participant dataSharing planned: Yes. Will be available after request
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Healthy Participants
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 High beta glucans, Low beta glucans and Low beta glucans + low polar lipids in people with Healthy Subjects, 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 3 inclusion and 6 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 21 Jan 2022. 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?
Glucose tolerance (time frame: 3 hours. Fasting (time =0 minutes), 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 21 Jan 2022.