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Completed

NCT Number: NCT03293693

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo and Akershus university College

Oslo, 0130, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

0.5 g beta-glucan

Other

Dietary cross-over study with beta-glucan fiber

3.5 g beta-glucan

Other

Dietary cross-over study with beta-glucan fiber

8 g beta-glucan

Other

Dietary cross-over study with beta-glucan fiber

Primary outcomes

  1. Postprandial blood glucose response

    Time frame: At day 4

    Blood glucose response after OGTT

  2. Postprandial insulin response

    Time frame: At day 4

    insulin response after OGTT

Secondary outcomes

  1. H2 breath response

    Time frame: At day 4

    H2 breath response after OGTT

  2. Free fatty acids

    Time frame: At day 4

    Plasma free fatty acids are measured after intake of test meals

  3. 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

  4. Serum triglyceride response

    Time frame: At day 4

    Triglyceride response are measured are measured after OGTT

  5. Serum cholesterol

    Time frame: At day 4

    Serum cholesterol are measured fasting after intake of test meals

  6. hunger and satiety hormones (e.g. GLP1)

    Time frame: At day 4

    The response in hunger and satiety hormones after OGTT

  7. Inflammatory markers (e.g. CRP)

    Time frame: At day 4

    Response in Inflammatory markers are measured after OGTT

  8. 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

  9. 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

  10. 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.

  11. Visual analogue scale (VAS)

    Time frame: At day 1

    Subjective hunger and satiety will be estimated after intake of test meals for one day

  12. Visual analogue scale (VAS)

    Time frame: At day 3

    Subjective hunger and satiety will be estimated after intake of test meals for three days

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Collaborators

  • Mills DA
  • Nofima
  • University of Oslo

Registry information

Official study title

Beta-glucan and Blood Glucose

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 26, 2017
Registry last updated
Sep 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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