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Intake of Beta-glucan and Postprandial Regulation of Blood Glucose Metabolism in Healthy Subjects

Beta-glucan and Blood Glucose

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03293693
Enrollment
14
Registered
2017-09-26
Start date
2016-10-31
Completion date
2017-06-30
Last updated
2017-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Microbiota, Post Prandial Blood Glucose, Satiety

Keywords

beta-glucan, Blood glucose, Gut microbiota, Satiety, Dietary intervention

Brief 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 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.

Interventions

OTHER0.5 g beta-glucan

Dietary cross-over study with beta-glucan fiber

OTHER3.5 g beta-glucan

Dietary cross-over study with beta-glucan fiber

OTHER8 g beta-glucan

Dietary cross-over study with beta-glucan fiber

Sponsors

Mills DA
CollaboratorINDUSTRY
Nofima
CollaboratorOTHER
University of Oslo
CollaboratorOTHER
Oslo Metropolitan University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Intervention With cross-over design. Three test meals will be tested.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI between 18,5 and 27 kg/m2 * Fasting plasma glucose ≤ 6.1 mmol/l

Exclusion criteria

* 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 * 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)

Design outcomes

Primary

MeasureTime frameDescription
Postprandial blood glucose responseAt day 4Blood glucose response after OGTT
Postprandial insulin responseAt day 4insulin response after OGTT

Secondary

MeasureTime frameDescription
Microbiota analyses in fecesAt day 4Microbiota analyses in feces are measured before and after intake of test meals. Change in microbiota will be analysed
Serum triglyceride responseAt day 4Triglyceride response are measured are measured after OGTT
Serum cholesterolAt day 4Serum cholesterol are measured fasting after intake of test meals
hunger and satiety hormones (e.g. GLP1)At day 4The response in hunger and satiety hormones after OGTT
H2 breath responseAt day 4H2 breath response after OGTT
mRNA analyses in PBMC (RT-PCR)At day 4PBMC are collected before and after OGTT. The change in mRNA level will be analyzed
Quantitative assessment of metabolites in urineAt day 4Morning 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
Quantitative assessment of metabolites in plasmaAt day 4Plasma for metabolome analyses are collected after intake of test meals. Metabolites in plasma will be quantified using UHPLC-qTOF-MS.
Visual analogue scale (VAS)At day 1Subjective hunger and satiety will be estimated after intake of test meals for one day
Inflammatory markers (e.g. CRP)At day 4Response in Inflammatory markers are measured after OGTT
Free fatty acidsAt day 4Plasma free fatty acids are measured after intake of test meals

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026