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

September 25, 2017 updated by: Oslo Metropolitan University

Beta-glucan and Blood Glucose

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

Study Overview

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Oslo, Norway, 0130
        • Oslo and Akershus University College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test meal 1
Test meal with 0.5 g beta-glucan
Dietary cross-over study with beta-glucan fiber
Experimental: Test meal 2
Test meal with 3.5 g beta-glucan
Dietary cross-over study with beta-glucan fiber
Experimental: Test meal 3
Test meal with 8 g beta-glucan
Dietary cross-over study with beta-glucan fiber

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial blood glucose response
Time Frame: At day 4
Blood glucose response after OGTT
At day 4
Postprandial insulin response
Time Frame: At day 4
insulin response after OGTT
At day 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H2 breath response
Time Frame: At day 4
H2 breath response after OGTT
At day 4
Free fatty acids
Time Frame: At day 4
Plasma free fatty acids are measured after intake of test meals
At day 4
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
At day 4
Serum triglyceride response
Time Frame: At day 4
Triglyceride response are measured are measured after OGTT
At day 4
Serum cholesterol
Time Frame: At day 4
Serum cholesterol are measured fasting after intake of test meals
At day 4
hunger and satiety hormones (e.g. GLP1)
Time Frame: At day 4
The response in hunger and satiety hormones after OGTT
At day 4
Inflammatory markers (e.g. CRP)
Time Frame: At day 4
Response in Inflammatory markers are measured after OGTT
At day 4
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
At day 4
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
At day 4
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.
At day 4
Visual analogue scale (VAS)
Time Frame: At day 1
Subjective hunger and satiety will be estimated after intake of test meals for one day
At day 1
Visual analogue scale (VAS)
Time Frame: At day 3
Subjective hunger and satiety will be estimated after intake of test meals for three days
At day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mari CW Myhrstad, PhD, Oslo and Akershus University College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (Actual)

September 26, 2017

Study Record Updates

Last Update Posted (Actual)

September 26, 2017

Last Update Submitted That Met QC Criteria

September 25, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2016/648

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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