Diet Prevention of Metabolic DiseasesNCT03944343
Prebiotic Effects on Glucose Tolerance
A study testing Cereal based products in people with Diet Prevention of Metabolic Diseases, run by Lund University at 1 site in Sweden.
Trial summary
The primary purpose of this project is to evaluate effects in healthy humans on glucose tolerance of cereal products with high amounts of fermentable dietary fibre. Secondary issues are to investigate effects of the test foods on subjective appetite variables, mood variables and gut microbiota composition. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Prevention of Metabolic Diseases
- What is being tested?
- Cereal based products
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteSweden
- Study dates
- 15 Oct 2019to 24 Jun 2020
- 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
- BMI 18.5 - 25 kg/m2
- age 20-40 years
- normal diet
- healthy
Who cannot join
- fasting blood glucose >6.1
- diagnosed or known disease
- known gastrointestinal disorder
- food allergies or intolerance
- special diet regiments
- smokers
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: Validation of a New Antidiabetic Food Concept Based on the Modulation of the Intestinal Flora
The primary purpose of this project is to evaluate effects in healthy humans on glucose tolerance of cereal products with high amounts of fermentable dietary fibre. Secondary issues are to investigate effects of the test foods on subjective appetite variables, mood variables and gut microbiota composition. The test food products will be consumed in the evening and test variables will be determined the next morning. The study will apply a randomized crossover study design.
- Conditions
- Diet Prevention of Metabolic Diseases
- Being tested
- Cereal based products
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cereal based productsOther
The cereal products are made from common Swedish cereals.
| Study group | Role | What they receive |
|---|---|---|
| Reference product | Sham comparator | Commercial cereals and a commercial yogurt Receives: Other: Cereal based products |
| Test product A | Experimental | Specific designed cereals A and yogurt Receives: Other: Cereal based products |
| Test product B | Experimental | Specific designed cereals B and yogurt Receives: Other: Cereal based products |
| Test product C | Experimental | Specific designed cereals C and yogurt Receives: Other: Cereal based products |
| Test product D | Experimental | Specific designed cereals D and yogurt Receives: Other: Cereal based products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance
The incremental (3 hours) blood glucose area under the curve after a standardized breakfast, following consumption of the test- or reference products the previous evening. Glucose concentrations will be analysed from capillary blood at fasting and at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min and 180 min after the standardized breakfast.
Measured: 3 hours
Secondary outcomes (3)
Subjective appetite variables
Determination of appetite variables (satiety, hunger and desire to eat) at fasting in the morning and after the standardized breakfast following consumption of the test- or reference products the previous evening. The appetite sensations will be determined at fasting and then at 30 min, 60 min, 90 min, 120 min, 150 min and at 180 min. The variables will be determined by registration on a 0-100 mm visual analogue scales (VAS). Higher ratings are considered to be better for the rating of satiety meanwhile lower ratings are considered to be better for hunger and desire to eat.
Measured: 3 hours
Mood parameters
Determination of mood variables (activity and valence) at fasting in the morning and after the andardized breakfast, following consumption of the test- or reference products the previous evening. The mood variables will be determined at fasting and then at 60 min, 120 min and at 180 min. The variables will be determined by registration on a 0-100 mm visual analogue scales (VAS).
Measured: 3 hours
Breath hydrogen
Determination of breath hydrogen concentrations will be performed at fasting and after the standardized breakfast, following consumption of the test- or reference products the previous evening. Breath hydrogen will be determined at fasting and then at 30 min, 60 min, 90 min, 120 min, 150 min and at 180 min. Breath hydrogen will be measured by exhaling in a portable measuring device.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start15 Oct 2019
- Primary completion15 Jun 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet Prevention of Metabolic DiseasesStudies 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
- Model description
- Randomized crossover study design. Healthy young adult volunteers.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Nilsson, Lund University
- Investigators
- Anne Nilsson, associate professor, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944343
- Sponsor's protocol ID
- 2018/1
- Status last verified
- Jun 2020
- First submitted
- 8 May 2019
- Last updated
- 25 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Antidiabetic Food Concept Based on the Modulation of the Intestinal Flora
- ClinicalTrials.gov ID
- NCT03944343
- Acronym / sponsor ID
- 2018/1
- Conditions
- Diet Prevention of Metabolic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 9 May 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.
The primary purpose of this project is to evaluate effects in healthy humans on glucose tolerance of cereal products with high amounts of fermentable dietary fibre. Secondary issues are to investigate effects of the test foods on subjective appetite variables, mood variables and gut microbiota composition. The test food products will be consumed in the evening and test variables will be determined the next morning. The study will apply a randomized crossover study design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Randomized crossover study design. Healthy young adult volunteers.
| Arm | Type | Receives |
|---|---|---|
| Reference product | Sham comparator | Other: Cereal based productsCommercial cereals and a commercial yogurt |
| Test product A | Experimental | Other: Cereal based productsSpecific designed cereals A and yogurt |
| Test product B | Experimental | Other: Cereal based productsSpecific designed cereals B and yogurt |
| Test product C | Experimental | Other: Cereal based productsSpecific designed cereals C and yogurt |
| Test product D | Experimental | Other: Cereal based productsSpecific designed cereals D and yogurt |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI 18.5 - 25 kg/m2
- age 20-40 years
- normal diet
- healthy
Key exclusion criteria (6 listed)
- fasting blood glucose >6.1
- diagnosed or known disease
- known gastrointestinal disorder
- food allergies or intolerance
- special diet regiments
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 |
|---|---|---|
| Cereal based productsThe cereal products are made from common Swedish cereals. | Other | Reference product, Test product A, Test product B, Test product C, Test product D |
Primary outcome
Glucose tolerance
Time frame: 3 hours
The incremental (3 hours) blood glucose area under the curve after a standardized breakfast, following consumption of the test- or reference products the previous evening. Glucose concentrations will be analysed from capillary blood at fasting and at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min and 180 min after the standardized breakfast.
3 secondary outcomes
Subjective appetite variables
Time frame: 3 hours
Mood parameters
Time frame: 3 hours
Breath hydrogen
Time frame: 3 hours
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 25 Jun 2020.
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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.
Anne Nilsson, associate professor principal investigator
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 Cereal based products in people with Diet Prevention of Metabolic Diseases, 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 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 25 Jun 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?
Glucose tolerance (time frame: 3 hours). 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 25 Jun 2020.