Post Prandial Blood GlucoseNCT03293693
Intake of Beta-glucan and Postprandial Regulation of Blood Glucose Metabolism in Healthy Subjects
A study testing 0.5 g beta-glucan, 3.5 g beta-glucan and 8 g beta-glucan in people with Post Prandial Blood Glucose and Gut Microbiota, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
The overall aim is to investigate the intake of beta-glucan in relation to glucose metabolism and satiety in a postprandial study with healthy subjects. The potential effects will be related to changes in the gut microbiota, the circulating levels of short chain fatty acids, inflammation and gene expression in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Prandial Blood Glucose, Gut Microbiota, Satiety
- What is being tested?
- 0.5 g beta-glucan, 3.5 g beta-glucan and 8 g beta-glucan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2016to Jun 2017
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 18,5 and 27 kg/m2
- Fasting plasma glucose ≤ 6.1 mmol/l
Who cannot join
- Chronic metabolic diseases such as diabetes type 1 and 2, coronary heart disease and cancer the last 6 months.
- Intestinal diseases such as chrons disease, ulcerative colitis and irritable bowel syndrome.
- Food allergy and intolerances towards grain and dairy products.
- Pregnant and lactating
- Smokers
- Fasting blood glucose ≥ 6.1 mmol/L
Show all 15Show fewer
- CRP > 10 mg/L, measured at baseline (visit 0)
- BMI <18,5 and >27 kg/m2
- Planned weight reduction and or ± 5% weight change over the past three months.
- Use of antibiotics last 3 months before study entry and during the study period
- Use of probiotics the last month before study entry and during the study period
- Blood donor last 2 months before study entry and or during the study period
- Not willing to end the use of dietary supplements four weeks prior to study entry and throughout the study period
- Alcohol consumption > 40g / day
- Hormone treatments (except contraceptives)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beta-glucan and Blood Glucose
The overall aim is to investigate the intake of beta-glucan in relation to glucose metabolism and satiety in a postprandial study with healthy subjects. The potential effects will be related to changes in the gut microbiota, the circulating levels of short chain fatty acids, inflammation and gene expression in peripheral mononuclear blood cells
Read the detailed description
The intervention study will have a fixed order, cross-over design with three test meals containing low (0.5 g / 100 g of product), medium (3.5 g / 100 g of product) and high (8 g / 100 g product) amount of beta -glucans, respectively. The test meals are in the form of cereals. All participants will eat the three test meals three constitutive days with 2 weeks apart. At day four, the participants will perform a postprandial glucose test (OGTT, 75 g glucose in 150 ml water) at Oslo and Akershus University College. Blood samples will be taken before and at different time points after glucose test.
At the screening visit the participants will be asked to limit the intake of dietary fiber from grains two weeks prior to the baseline visit (0) and during the study. Otherwise, participants will be asked not to change their diet and exercise habits during the study period.
At the baseline visit (visit 0) an OGTT will be performed. OGTT will also be performed at visit 1, 3 and 5 after intake of low, medium and high beta-glucan, respectively.
The participants will receive the test meals at visit 1, 2 and 4.
- Conditions
- Post Prandial Blood Glucose, Gut Microbiota, Satiety
- Being tested
- 0.5 g beta-glucan, 3.5 g beta-glucan, 8 g beta-glucan
- Keywords
- beta-glucan, Blood glucose, Gut microbiota, Satiety, Dietary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 g beta-glucanOther
Dietary cross-over study with beta-glucan fiber
3.5 g beta-glucanOther
Dietary cross-over study with beta-glucan fiber
8 g beta-glucanOther
Dietary cross-over study with beta-glucan fiber
| Study group | Role | What they receive |
|---|---|---|
| Test meal 1 | Experimental | Test meal with 0.5 g beta-glucan Receives: Other: 0.5 g beta-glucan |
| Test meal 2 | Experimental | Test meal with 3.5 g beta-glucan Receives: Other: 3.5 g beta-glucan |
| Test meal 3 | Experimental | Test meal with 8 g beta-glucan Receives: Other: 8 g beta-glucan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial blood glucose response
Blood glucose response after OGTT
Measured: At day 4
Postprandial insulin response
insulin response after OGTT
Measured: At day 4
Secondary outcomes (12)
H2 breath response
H2 breath response after OGTT
Measured: At day 4
Free fatty acids
Plasma free fatty acids are measured after intake of test meals
Measured: At day 4
Microbiota analyses in feces
Microbiota analyses in feces are measured before and after intake of test meals. Change in microbiota will be analysed
Measured: At day 4
Serum triglyceride response
Triglyceride response are measured are measured after OGTT
Measured: At day 4
Serum cholesterol
Serum cholesterol are measured fasting after intake of test meals
Measured: At day 4
hunger and satiety hormones (e.g. GLP1)
The response in hunger and satiety hormones after OGTT
Measured: At day 4
Inflammatory markers (e.g. CRP)
Response in Inflammatory markers are measured after OGTT
Measured: At day 4
mRNA analyses in PBMC (RT-PCR)
PBMC are collected before and after OGTT. The change in mRNA level will be analyzed
Measured: At day 4
Quantitative assessment of metabolites in urine
Morning urine are collected before and after intake of test meals. Metabolites in urine will be quantified using UHPLC-qTOF-MS. Change in metabolites before and after test meals will be analyzed
Measured: At day 4
Quantitative assessment of metabolites in plasma
Plasma for metabolome analyses are collected after intake of test meals. Metabolites in plasma will be quantified using UHPLC-qTOF-MS.
Measured: At day 4
Visual analogue scale (VAS)
Subjective hunger and satiety will be estimated after intake of test meals for one day
Measured: At day 1
Visual analogue scale (VAS)
Subjective hunger and satiety will be estimated after intake of test meals for three days
Measured: At day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study startOct 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Prandial Blood GlucoseStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Intervention With cross-over design. Three test meals will be tested.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Mills DA, Nofima, University of Oslo
- Responsible party
- Sponsor
- Investigators
- Mari CW Myhrstad, PhD, Principal investigator, Oslo and Akershus University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293693
- Sponsor's protocol ID
- 2016/648
- Status last verified
- Sep 2017
- First submitted
- 10 Mar 2017
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Telle-Hansen VH, Gaundal L, Hogvard B, Ulven SM, Holven KB, Byfuglien MG, Mage I, Knutsen SH, Ballance S, Rieder A, Rud I, Myhrstad MCW. A Three-Day Intervention With Granola Containing Cereal Beta-Glucan Improves Glycemic Response and Changes the Gut Microbiota in Healthy Individuals: A Crossover Study. Front Nutr. 2022 Apr 28;9:796362. doi: 10.3389/fnut.2022.796362. eCollection 2022.
PubMed 35578615
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-glucan and Blood Glucose
- ClinicalTrials.gov ID
- NCT03293693
- Acronym / sponsor ID
- 2016/648
- Conditions
- Post Prandial Blood Glucose, Gut Microbiota, Satiety
- Keywords
- beta-glucan, Blood glucose, Gut microbiota, Satiety, Dietary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Mills DA, Nofima, University of Oslo
- Study start
- Oct 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 26 Sep 2017 (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 aim is to investigate the intake of beta-glucan in relation to glucose metabolism and satiety in a postprandial study with healthy subjects. The potential effects will be related to changes in the gut microbiota, the circulating levels of short chain fatty acids, inflammation and gene expression in peripheral mononuclear blood cells
Detailed description
The intervention study will have a fixed order, cross-over design with three test meals containing low (0.5 g / 100 g of product), medium (3.5 g / 100 g of product) and high (8 g / 100 g product) amount of beta -glucans, respectively. The test meals are in the form of cereals. All participants will eat the three test meals three constitutive days with 2 weeks apart. At day four, the participants will perform a postprandial glucose test (OGTT, 75 g glucose in 150 ml water) at Oslo and Akershus University College. Blood samples will be taken before and at different time points after glucose test.
At the screening visit the participants will be asked to limit the intake of dietary fiber from grains two weeks prior to the baseline visit (0) and during the study. Otherwise, participants will be asked not to change their diet and exercise habits during the study period.
At the baseline visit (visit 0) an OGTT will be performed. OGTT will also be performed at visit 1, 3 and 5 after intake of low, medium and high beta-glucan, respectively.
The participants will receive the test meals at visit 1, 2 and 4.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Intervention With cross-over design. Three test meals will be tested.
| Arm | Type | Receives |
|---|---|---|
| Test meal 1 | Experimental | Other: 0.5 g beta-glucanTest meal with 0.5 g beta-glucan |
| Test meal 2 | Experimental | Other: 3.5 g beta-glucanTest meal with 3.5 g beta-glucan |
| Test meal 3 | Experimental | Other: 8 g beta-glucanTest meal with 8 g beta-glucan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI between 18,5 and 27 kg/m2
- Fasting plasma glucose ≤ 6.1 mmol/l
Key exclusion criteria (15 listed)
- Chronic metabolic diseases such as diabetes type 1 and 2, coronary heart disease and cancer the last 6 months.
- Intestinal diseases such as chrons disease, ulcerative colitis and irritable bowel syndrome.
- Food allergy and intolerances towards grain and dairy products.
- Pregnant and lactating
- Smokers
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 |
|---|---|---|
| 0.5 g beta-glucanDietary cross-over study with beta-glucan fiber | Other | Test meal 1 |
| 3.5 g beta-glucanDietary cross-over study with beta-glucan fiber | Other | Test meal 2 |
| 8 g beta-glucanDietary cross-over study with beta-glucan fiber | Other | Test meal 3 |
Primary outcome
Postprandial blood glucose response
Time frame: At day 4
Blood glucose response after OGTT
Postprandial insulin response
Time frame: At day 4
insulin response after OGTT
12 secondary outcomes
H2 breath response
Time frame: At day 4
Free fatty acids
Time frame: At day 4
Microbiota analyses in feces
Time frame: At day 4
Serum triglyceride response
Time frame: At day 4
Serum cholesterol
Time frame: At day 4
hunger and satiety hormones (e.g. GLP1)
Time frame: At day 4
Inflammatory markers (e.g. CRP)
Time frame: At day 4
mRNA analyses in PBMC (RT-PCR)
Time frame: At day 4
Quantitative assessment of metabolites in urine
Time frame: At day 4
Quantitative assessment of metabolites in plasma
Time frame: At day 4
Visual analogue scale (VAS)
Time frame: At day 1
Visual analogue scale (VAS)
Time frame: At day 3
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 26 Sep 2017.
- Derived from this study: PubMed 35578615Telle-Hansen VH, Gaundal L, Hogvard B, Ulven SM, Holven KB, Byfuglien MG, Mage I, Knutsen SH, Ballance S, Rieder A, Rud I, Myhrstad MCW. A Three-Day Intervention With Granola Containing Cereal Beta-Glucan Improves Glycemic Response and Changes the Gut Microbiota in Healthy Individuals: A Crossover Study. Front Nutr. 2022 Apr 28;9:796362. doi: 10.3389/fnut.2022.796362. eCollection 2022.
Related trials for Post Prandial Blood Glucose
Not yet recruiting
Effect of Proso Millet-Based Bread on Postprandial Glycemic Response in Adults With Type 2 Diabetes
Tip 2 Diabetes Mellitus
Recruiting
Relaxing Virtual Reality Use and Blood Glucose Response to Food (ReViR) Study
Post Prandial Blood Glucose, Feasibility Pilot Study
Active, not recruiting
How Fig Polyphenols Affect Blood Sugar and Insulin Levels After Eating in Adults at Risk for Diabetes
Pre Diabetic
Not yet recruiting
Glycemic Effects of Meals - Repeatability Trial With Continuous Glucose Monitoring
Glucose Response
Recruiting
Determining the Effect of Food Ordering on Blood Glucose In Gestational Diabetes Mellitus (DEFI-GDM)
Gestational Diabetes Mellitus (GDM)
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.
Mari CW Myhrstad, PhD principal investigator
Oslo and Akershus University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.5 g beta-glucan, 3.5 g beta-glucan and 8 g beta-glucan in people with Post Prandial Blood Glucose and Gut Microbiota, run by Oslo Metropolitan University at 1 site in Norway.
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 2 inclusion and 15 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 26 Sep 2017. 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 Norway. 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?
Postprandial blood glucose response (time frame: At day 4). The study lists 2 primary outcomes in all. 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 NCT03293693, which also lists 1 linked publication.
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 26 Sep 2017.