Glucose ToleranceNCT03423381
Dietary Fibre and Metabolic Benefits
A study testing Cereal product 1, Cereal product 2 and Cereal product 3 in people with Glucose Tolerance, run by Lund University at 1 site in Sweden.
Trial summary
The aim of the project is to study the connection between bacterial fermentation in the colon of prebiotic substrates and effects on systemic metabolism and appetite i healthy humans Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Tolerance
- What is being tested?
- Cereal product 1, Cereal product 2 and Cereal product 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- 30 May 2018to 28 Feb 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults
- BMI<30
- non smokers
- consuming a non-vegetarian diet that follows the Nordic guidances
Who cannot join
- fasting blood glucose >6.1 mmol/L
- known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome), gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies. Further no antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Food Technology, engineering and Nutrition, LTH, Lund University
Lund, 22100
About this study
Official title: Validation of a New Antidiabetic Food Concept Based on Modulation of the Gut Microbiota
The aim of the project is to study the connection between bacterial fermentation in the colon of prebiotic substrates and effects on systemic metabolism and appetite i healthy humans
Read the detailed description
The purpose with this project is to study the association between bacterial fermentation in the colon of specific mixtures of cereal dietary fiber and effects on systemic metabolism and appetite regulation. For this purpose, short term studies are performed in healthy adult subjects. Different cereals, cereal blends and from cereal extracted dietary fiber will be studied, as well as effects of different processing of the cereals. Cardiometabolic test markers and colonic fermentation metabolites will be followed up to 14 h after intake of the test substrates, and gut microbiota composition will be determined prior to and after the interventions.
- Conditions
- Glucose Tolerance
- Being tested
- Cereal product 1, Cereal product 2, Cereal product 3, Cereal product 4, Cereal product 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cereal product 1Other
Cereal products based on rye, barley, wheat, oat, and corn
Cereal product 2Other
Cereal products based on rye, barley, wheat, oat, and corn
Cereal product 3Other
Cereal products based on rye, barley, wheat, oat, and corn
Cereal product 4Other
Cereal products based on rye, barley, wheat, oat, and corn
Cereal product 5Other
Cereal products based on rye, barley, wheat, oat, and corn
Control productOther
A cereal based product with low concentrations of df
| Study group | Role | What they receive |
|---|---|---|
| Cereal product 1 | Experimental | Cereal based müsli no. 1, made from typical Swedish cereals. All experimental products have different types and amounts of dietary fibre (df). The test portion is consumed as a single evening meal prior to determinations of test variables in the morning. Receives: Other: Cereal product 1 |
| Cereal product 2 | Experimental | Cereal based muesli no. 2 made from typical Swedish cereals. All experimental products have different types and amounts of df. The test portion is consumed as a single evening meal prior to determinations of test variables in the morning. Receives: Other: Cereal product 2 |
| Cereal product 3 | Experimental | Cereal based muesli no.3 made from typical Swedish cereals. All experimental products have different types and amounts of df.The test portion is consumed as a single evening meal prior to determinations of test variables in the morning. Receives: Other: Cereal product 3 |
| Cereal product 4 | Experimental | Cereal based muesli no. 4 made from typical Swedish cereals. All experimental products have different types and amounts of df. The test portion is consumed as a single evening meal prior to determinations of test variables in the morning. Receives: Other: Cereal product 4 |
| Cereal product 5 | Experimental | Cereal based muesli no. 5 made from typical Swedish cereals. All experimental products have different types and amounts of df. The test portion is consumed as a single evening meal prior to determinations of test variables in the morning. Receives: Other: Cereal product 5 |
| Control product | Placebo comparator | A cereal based product with low concentrations of df. The control portion is consumed as a single evening meal prior to determinations of test variables in the morning. Receives: Other: Control product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose regulation
Postprandial blood glucose regulation (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 14 h after consumption of test products.
Measured: 0-14 h after intake
Secondary outcomes (11)
serum insulin
Postprandial serum insulin concentrations (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 14 h after consumption of test products.
Measured: 0-14 h after intake
gut microbiota composition
effects on gut microbiota composition after intake of prebiotics
Measured: first stool delivered from14 h after intake
plasma GLP-1 (glucagon-like peptide-1 ), PYY (peptide tyrosine tyrosine), Ghrelin
Gastro-intestinale hormones involved in appetite and metabolic regulation
Measured: 0-14 h after intake
plasma: CRP (C reactive protein ), IL (interleukin)-6, IL-18, IL-8, IL-1, IL-10, LBP (lipopolysaccharide-binding protein), (PAI-1plasminogen activator inhibitor)
Inflammatory markers in blood
Measured: 0-14 h after intake
plasma GLP-2
gut hormone involved in gut mucosa integrity
Measured: 0-14 h after intake
plasma SCFA (short-chain fatty acid)
colonic fermentation metabolites
Measured: 0-14 h after intake
blood lipids
cholesterol and free fatty acids in plasma
Measured: 0-14 h after intake
plasma adiponectin
hormone involved in metabolic regulation
Measured: 0-14 h after intake
plasma BDNF (Brain-derived neurotrophic factor)
signal protein important for brain functions, but also involved in metabolic regulation
Measured: 0-14 h after intake
plasma neurotensin
a neuro peptide peptides involved in appetite and metabolic regulation
Measured: 0-14 h after intake
plasma Nesfatin-1
a neuro peptide that participates in the regulation of hunger and fat storage.
Measured: 0-14 h after intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start30 May 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Glucose ToleranceStudies 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
- Crossover randomised
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Vinnova, Öste Venture AB
- Responsible party
- Principal investigator, Anne Nilsson, Lund University
- Investigators
- Anne Nilsson, PhD, Principal investigator, Food Technology, engineering, and Nutrition, LTH, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423381
- Sponsor's protocol ID
- 2017-03575
- Other IDs
- 2017
- Status last verified
- Mar 2019
- First submitted
- 29 Dec 2017
- Last updated
- 25 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nilsson AC, Ostman EM, Knudsen KE, Holst JJ, Bjorck IM. A cereal-based evening meal rich in indigestible carbohydrates increases plasma butyrate the next morning. J Nutr. 2010 Nov;140(11):1932-6. doi: 10.3945/jn.110.123604. Epub 2010 Sep 1.
PubMed 20810606Nilsson AC, Johansson-Boll EV, Bjorck IM. Increased gut hormones and insulin sensitivity index following a 3-d intervention with a barley kernel-based product: a randomised cross-over study in healthy middle-aged subjects. Br J Nutr. 2015 Sep 28;114(6):899-907. doi: 10.1017/S0007114515002524. Epub 2015 Aug 11.
PubMed 26259632Kovatcheva-Datchary P, Nilsson A, Akrami R, Lee YS, De Vadder F, Arora T, Hallen A, Martens E, Bjorck I, Backhed F. Dietary Fiber-Induced Improvement in Glucose Metabolism Is Associated with Increased Abundance of Prevotella. Cell Metab. 2015 Dec 1;22(6):971-82. doi: 10.1016/j.cmet.2015.10.001. Epub 2015 Nov 6.
PubMed 26552345Sandberg JC, Bjorck IM, Nilsson AC. Rye-Based Evening Meals Favorably Affected Glucose Regulation and Appetite Variables at the Following Breakfast; A Randomized Controlled Study in Healthy Subjects. PLoS One. 2016 Mar 18;11(3):e0151985. doi: 10.1371/journal.pone.0151985. eCollection 2016.
PubMed 26990559Sandberg JC, Bjorck IME, Nilsson AC. Effects of whole grain rye, with and without resistant starch type 2 supplementation, on glucose tolerance, gut hormones, inflammation and appetite regulation in an 11-14.5 hour perspective; a randomized controlled study in healthy subjects. Nutr J. 2017 Apr 21;16(1):25. doi: 10.1186/s12937-017-0246-5.
PubMed 28431559Nilsson AC, Ostman EM, Holst JJ, Bjorck IM. Including indigestible carbohydrates in the evening meal of healthy subjects improves glucose tolerance, lowers inflammatory markers, and increases satiety after a subsequent standardized breakfast. J Nutr. 2008 Apr;138(4):732-9. doi: 10.1093/jn/138.4.732.
PubMed 18356328
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Antidiabetic Food Concept Based on Modulation of the Gut Microbiota
- ClinicalTrials.gov ID
- NCT03423381
- Acronym / sponsor ID
- 2017-03575
- Conditions
- Glucose Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Vinnova, Öste Venture AB
- Study start
- 30 May 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 6 Feb 2018 (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 aim of the project is to study the connection between bacterial fermentation in the colon of prebiotic substrates and effects on systemic metabolism and appetite i healthy humans
Detailed description
The purpose with this project is to study the association between bacterial fermentation in the colon of specific mixtures of cereal dietary fiber and effects on systemic metabolism and appetite regulation. For this purpose, short term studies are performed in healthy adult subjects. Different cereals, cereal blends and from cereal extracted dietary fiber will be studied, as well as effects of different processing of the cereals. Cardiometabolic test markers and colonic fermentation metabolites will be followed up to 14 h after intake of the test substrates, and gut microbiota composition will be determined prior to and after the interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- Crossover randomised
| Arm | Type | Receives |
|---|---|---|
| Cereal product 1 | Experimental | Other: Cereal product 1Cereal based müsli no. 1, made from typical Swedish cereals. All experimental products have different types and amounts of dietary fibre (df). The test portion is consumed as a single evening meal prior to determinations of test variables in the morning. |
| Cereal product 2 | Experimental | Other: Cereal product 2Cereal based muesli no. 2 made from typical Swedish cereals. All experimental products have different types and amounts of df. The test portion is consumed as a single evening meal prior to determinations of test variables in the morning. |
| Cereal product 3 | Experimental | Other: Cereal product 3Cereal based muesli no.3 made from typical Swedish cereals. All experimental products have different types and amounts of df.The test portion is consumed as a single evening meal prior to determinations of test variables in the morning. |
| Cereal product 4 | Experimental | Other: Cereal product 4Cereal based muesli no. 4 made from typical Swedish cereals. All experimental products have different types and amounts of df. The test portion is consumed as a single evening meal prior to determinations of test variables in the morning. |
| Cereal product 5 | Experimental | Other: Cereal product 5Cereal based muesli no. 5 made from typical Swedish cereals. All experimental products have different types and amounts of df. The test portion is consumed as a single evening meal prior to determinations of test variables in the morning. |
| Control product | Placebo comparator | Other: Control productA cereal based product with low concentrations of df. The control portion is consumed as a single evening meal prior to determinations of test variables in the morning. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- healthy adults
- BMI<30
- non smokers
- consuming a non-vegetarian diet that follows the Nordic guidances
Key exclusion criteria (2 listed)
- fasting blood glucose >6.1 mmol/L
- known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome), gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies. Further no antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study.
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 product 1Cereal products based on rye, barley, wheat, oat, and corn | Other | Cereal product 1 |
| Cereal product 2Cereal products based on rye, barley, wheat, oat, and corn | Other | Cereal product 2 |
| Cereal product 3Cereal products based on rye, barley, wheat, oat, and corn | Other | Cereal product 3 |
| Cereal product 4Cereal products based on rye, barley, wheat, oat, and corn | Other | Cereal product 4 |
| Cereal product 5Cereal products based on rye, barley, wheat, oat, and corn | Other | Cereal product 5 |
| Control productA cereal based product with low concentrations of df | Other | Control product |
Primary outcome
Blood glucose regulation
Time frame: 0-14 h after intake
Postprandial blood glucose regulation (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 14 h after consumption of test products.
11 secondary outcomes
serum insulin
Time frame: 0-14 h after intake
gut microbiota composition
Time frame: first stool delivered from14 h after intake
plasma GLP-1 (glucagon-like peptide-1 ), PYY (peptide tyrosine tyrosine), Ghrelin
Time frame: 0-14 h after intake
plasma: CRP (C reactive protein ), IL (interleukin)-6, IL-18, IL-8, IL-1, IL-10, LBP (lipopolysaccharide-binding protein), (PAI-1plasminogen activator inhibitor)
Time frame: 0-14 h after intake
plasma GLP-2
Time frame: 0-14 h after intake
plasma SCFA (short-chain fatty acid)
Time frame: 0-14 h after intake
blood lipids
Time frame: 0-14 h after intake
plasma adiponectin
Time frame: 0-14 h after intake
plasma BDNF (Brain-derived neurotrophic factor)
Time frame: 0-14 h after intake
plasma neurotensin
Time frame: 0-14 h after intake
plasma Nesfatin-1
Time frame: 0-14 h after intake
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 Mar 2019.
- Background: PubMed 20810606Nilsson AC, Ostman EM, Knudsen KE, Holst JJ, Bjorck IM. A cereal-based evening meal rich in indigestible carbohydrates increases plasma butyrate the next morning. J Nutr. 2010 Nov;140(11):1932-6. doi: 10.3945/jn.110.123604. Epub 2010 Sep 1.
- Background: PubMed 26259632Nilsson AC, Johansson-Boll EV, Bjorck IM. Increased gut hormones and insulin sensitivity index following a 3-d intervention with a barley kernel-based product: a randomised cross-over study in healthy middle-aged subjects. Br J Nutr. 2015 Sep 28;114(6):899-907. doi: 10.1017/S0007114515002524. Epub 2015 Aug 11.
- Background: PubMed 26552345Kovatcheva-Datchary P, Nilsson A, Akrami R, Lee YS, De Vadder F, Arora T, Hallen A, Martens E, Bjorck I, Backhed F. Dietary Fiber-Induced Improvement in Glucose Metabolism Is Associated with Increased Abundance of Prevotella. Cell Metab. 2015 Dec 1;22(6):971-82. doi: 10.1016/j.cmet.2015.10.001. Epub 2015 Nov 6.
- Background: PubMed 26990559Sandberg JC, Bjorck IM, Nilsson AC. Rye-Based Evening Meals Favorably Affected Glucose Regulation and Appetite Variables at the Following Breakfast; A Randomized Controlled Study in Healthy Subjects. PLoS One. 2016 Mar 18;11(3):e0151985. doi: 10.1371/journal.pone.0151985. eCollection 2016.
- Background: PubMed 28431559Sandberg JC, Bjorck IME, Nilsson AC. Effects of whole grain rye, with and without resistant starch type 2 supplementation, on glucose tolerance, gut hormones, inflammation and appetite regulation in an 11-14.5 hour perspective; a randomized controlled study in healthy subjects. Nutr J. 2017 Apr 21;16(1):25. doi: 10.1186/s12937-017-0246-5.
- Background: PubMed 18356328Nilsson AC, Ostman EM, Holst JJ, Bjorck IM. Including indigestible carbohydrates in the evening meal of healthy subjects improves glucose tolerance, lowers inflammatory markers, and increases satiety after a subsequent standardized breakfast. J Nutr. 2008 Apr;138(4):732-9. doi: 10.1093/jn/138.4.732.
- 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.
Anne Nilsson, PhD principal investigator
Food Technology, engineering, and Nutrition, LTH, 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 product 1, Cereal product 2 and Cereal product 3 in people with Glucose Tolerance, 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 2 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 Mar 2019. 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 regulation (time frame: 0-14 h after intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03423381, which also lists 6 linked publications.
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 Mar 2019.