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

Overview

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

Full Title of Study: “Beta-glucan and Blood Glucose”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2017

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

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

Arms, Groups and Cohorts

  • Experimental: Test meal 1
    • Test meal with 0.5 g beta-glucan
  • Experimental: Test meal 2
    • Test meal with 3.5 g beta-glucan
  • Experimental: Test meal 3
    • Test meal with 8 g beta-glucan

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • H2 breath response
    • Time Frame: At day 4
    • H2 breath response after OGTT
  • Free fatty acids
    • Time Frame: At day 4
    • Plasma free fatty acids are measured after intake of test meals
  • Microbiota analyses in feces
    • Time Frame: At day 4
    • Microbiota analyses in feces are measured before and after intake of test meals. Change in microbiota will be analysed
  • Serum triglyceride response
    • Time Frame: At day 4
    • Triglyceride response are measured are measured after OGTT
  • Serum cholesterol
    • Time Frame: At day 4
    • Serum cholesterol are measured fasting after intake of test meals
  • hunger and satiety hormones (e.g. GLP1)
    • Time Frame: At day 4
    • The response in hunger and satiety hormones after OGTT
  • Inflammatory markers (e.g. CRP)
    • Time Frame: At day 4
    • Response in Inflammatory markers are measured after OGTT
  • mRNA analyses in PBMC (RT-PCR)
    • Time Frame: At day 4
    • PBMC are collected before and after OGTT. The change in mRNA level will be analyzed
  • Quantitative assessment of metabolites in urine
    • Time Frame: At day 4
    • 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
  • Quantitative assessment of metabolites in plasma
    • Time Frame: At day 4
    • Plasma for metabolome analyses are collected after intake of test meals. Metabolites in plasma will be quantified using UHPLC-qTOF-MS.
  • Visual analogue scale (VAS)
    • Time Frame: At day 1
    • Subjective hunger and satiety will be estimated after intake of test meals for one day
  • Visual analogue scale (VAS)
    • Time Frame: At day 3
    • Subjective hunger and satiety will be estimated after intake of test meals for three days

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Oslo Metropolitan University
  • Collaborator
    • Mills DA
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mari CW Myhrstad, PhD, Principal Investigator, Oslo and Akershus university College

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.