Clinical trial NCT03293693: Intake of Beta-glucan and Postprandial Regulation of Blood Glucose Metabolism in Healthy Subjects
Official title: Beta-glucan and Blood Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Prandial Blood Glucose
Gut Microbiota
Satiety
Keywords: beta-glucan
Blood glucose
Gut microbiota
Satiety
Dietary intervention
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: Mills DA
name: Nofima
name: University of Oslo
First posted: 2017-09-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Intervention With cross-over design. Three test meals will be tested.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Postprandial blood glucose response
timeFrame: At day 4
measure: Postprandial insulin response
timeFrame: At day 4
Secondary outcomes:
measure: H2 breath response
timeFrame: At day 4
measure: Free fatty acids
timeFrame: At day 4
measure: Microbiota analyses in feces
timeFrame: At day 4
measure: Serum triglyceride response
timeFrame: At day 4
measure: Serum cholesterol
timeFrame: At day 4
measure: hunger and satiety hormones (e.g. GLP1)
timeFrame: At day 4
measure: Inflammatory markers (e.g. CRP)
timeFrame: At day 4
measure: mRNA analyses in PBMC (RT-PCR)
timeFrame: At day 4
measure: Quantitative assessment of metabolites in urine
timeFrame: At day 4
measure: Quantitative assessment of metabolites in plasma
timeFrame: At day 4
measure: Visual analogue scale (VAS)
timeFrame: At day 1
measure: Visual analogue scale (VAS)
timeFrame: At day 3
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo and Akershus university College
Study officials:
affiliation: Oslo and Akershus University College
name: Mari CW Myhrstad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.