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

NCT ID: NCT03293693

Last Updated: 2017-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Post Prandial Blood Glucose Gut Microbiota Satiety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Intervention With cross-over design. Three test meals will be tested.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Test meal 1

Test meal with 0.5 g beta-glucan

Group Type EXPERIMENTAL

0.5 g beta-glucan

Intervention Type OTHER

Dietary cross-over study with beta-glucan fiber

Test meal 2

Test meal with 3.5 g beta-glucan

Group Type EXPERIMENTAL

3.5 g beta-glucan

Intervention Type OTHER

Dietary cross-over study with beta-glucan fiber

Test meal 3

Test meal with 8 g beta-glucan

Group Type EXPERIMENTAL

8 g beta-glucan

Intervention Type OTHER

Dietary cross-over study with beta-glucan fiber

Interventions

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0.5 g beta-glucan

Dietary cross-over study with beta-glucan fiber

Intervention Type OTHER

3.5 g beta-glucan

Dietary cross-over study with beta-glucan fiber

Intervention Type OTHER

8 g beta-glucan

Dietary cross-over study with beta-glucan fiber

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mills DA

INDUSTRY

Sponsor Role collaborator

Nofima

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

Oslo Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mari CW Myhrstad, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo and Akershus University College

Locations

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Oslo and Akershus university College

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 35578615 (View on PubMed)

Other Identifiers

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2016/648

Identifier Type: -

Identifier Source: org_study_id