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

Gut Microbiota Clinical Trial

Official title:

Beta-glucan and Blood Glucose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293693
• Other study ID #: 2016/648
• Status: Completed
• Phase: N/A
• First received: March 10, 2017
• Last updated: September 25, 2017
• Start date: October 2016
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: Oslo and Akershus University College of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 peripheral mononuclear blood cells

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gut Microbiota
• Post Prandial Blood Glucose
• Satiety

Intervention

Other:
• 0.5 g beta-glucan
Dietary cross-over study with beta-glucan fiber
• 3.5 g beta-glucan
Dietary cross-over study with beta-glucan fiber
• 8 g beta-glucan
Dietary cross-over study with beta-glucan fiber

Locations

Country	Name	City	State
Norway	Oslo and Akershus university College	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Oslo and Akershus University College of Applied Sciences	Mills DA, NOFIMA, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial blood glucose response	Blood glucose response after OGTT	At day 4
Primary	Postprandial insulin response	insulin response after OGTT	At day 4
Secondary	H2 breath response	H2 breath response after OGTT	At day 4
Secondary	Free fatty acids	Plasma free fatty acids are measured after intake of test meals	At day 4
Secondary	Microbiota analyses in feces	Microbiota analyses in feces are measured before and after intake of test meals. Change in microbiota will be analysed	At day 4
Secondary	Serum triglyceride response	Triglyceride response are measured are measured after OGTT	At day 4
Secondary	Serum cholesterol	Serum cholesterol are measured fasting after intake of test meals	At day 4
Secondary	hunger and satiety hormones (e.g. GLP1)	The response in hunger and satiety hormones after OGTT	At day 4
Secondary	Inflammatory markers (e.g. CRP)	Response in Inflammatory markers are measured after OGTT	At day 4
Secondary	mRNA analyses in PBMC (RT-PCR)	PBMC are collected before and after OGTT. The change in mRNA level will be analyzed	At day 4
Secondary	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	At day 4
Secondary	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.	At day 4
Secondary	Visual analogue scale (VAS)	Subjective hunger and satiety will be estimated after intake of test meals for one day	At day 1
Secondary	Visual analogue scale (VAS)	Subjective hunger and satiety will be estimated after intake of test meals for three days	At day 3