Beta-glucan and Blood Glucose
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Postprandial insulin response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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)
Arms & Interventions
Test meal 1
Test meal with 0.5 g beta-glucan
Intervention: 0.5 g beta-glucan (Other)
Test meal 2
Test meal with 3.5 g beta-glucan
Intervention: 3.5 g beta-glucan (Other)
Test meal 3
Test meal with 8 g beta-glucan
Intervention: 8 g beta-glucan (Other)
Outcomes
Primary Outcomes
Postprandial insulin response
Time Frame: At day 4
insulin response after OGTT
Postprandial blood glucose response
Time Frame: At day 4
Blood glucose response after OGTT
Secondary Outcomes
- Free fatty acids(At day 4)
- Microbiota analyses in feces(At day 4)
- Quantitative assessment of metabolites in urine(At day 4)
- H2 breath response(At day 4)
- Serum triglyceride response(At day 4)
- Inflammatory markers (e.g. CRP)(At day 4)
- mRNA analyses in PBMC (RT-PCR)(At day 4)
- Serum cholesterol(At day 4)
- hunger and satiety hormones (e.g. GLP1)(At day 4)
- Quantitative assessment of metabolites in plasma(At day 4)
- Visual analogue scale (VAS)(At day 3)