Effect of Dietary Fibre and Whole Grain on the Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01316354
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : April 19, 2012
University of Aarhus
Information provided by (Responsible Party):
AnneMarie Kruse, Aarhus University Hospital

Brief Summary:

Sedentary lifestyles and increasing obesity are main causes of the global increase in the prevalence of the metabolic syndrome (Mets) and type 2 diabetic (T2DM). Diet quality, particularly composition of carbohydrate play also a significant role. The glycemic index (GI) describes in relative terms rise of blood glucose after ingestion of carbohydrate-rich food. Purified dietary fibre as β-glucan (BG) has been shown to reduce GI and affect levels of satiety hormones. In contrast, our knowledge of the physiological effects of arabinoxylans (AX), which constitute a substantial part of dietary fibre in cereal products, is limited. The investigators also lack a deeper understanding of the importance of whole grain (whole grain with whole kernels, and purified dietary fibre) in relation to Mets and T2DM.

Hypothesis: The composition of dietary carbohydrates can be designed so that they improve the glycemic and insulinaemic responses and increase satiety feeling. This can be detected in metabolic parameters in subjects with Mets.

The aim of our study is in subjects with Mets to compare the effect of acute consumption of bread rich in (a) purified AX, (b) purified BG, (c) rye bread with whole kernels (RK), with a (d) control group with consumption of white bread (WB).

The primary endpoint is GI. Secondary endpoints are the following items: glycemic load, insulin index, glucose, insulin, glucagon, inflammatory markers, incretins, rate of gastric emptying, and metabolomics. Also satiety feeling will be measured.

This project will improve opportunities for identifying and designing foods with low GI that is particularly suited to people who are at high risk of developing T2DM. The investigators also expect to gain a greater understanding of the metabolic fingerprint, as seen after ingestion of low-GI foods and thereby gain a molecular understanding of how low-GI foods affect health by altering metabolic processes. This will give us a deeper insight into the metabolic processes that are necessary for maintaining normal glucose homeostasis.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Other: Bread types Not Applicable

Detailed Description:
Using a cross-over design, 12 subjects with Mets will consume test meals containing the four different bread types. Blood samples will be collected over 4,5 hours after ingestion of test meals containing around 145 g of each bread type, equivalent to 50 g available carbohydrate and 3 dl + 2 dl water on four different days in randomized order. Visual Analog Scale (VAS) will be used for determination of subjective satiety feeling and a subsequent meal will be served to estimate prospective food consumption.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Arabinoxylan and Beta-glucan Compared With Whole Grain and Whole Meal Bread in Subjects With the Metabolic Syndrome
Study Start Date : August 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: Beta-glucan
Bread with purified beta-glucan
Other: Bread types
Bread with 50 g available carbohydrate
Experimental: Rye kernels
Rye bread with kernels
Other: Bread types
Bread with 50 g available carbohydrate
Experimental: White bread
White bread
Other: Bread types
Bread with 50 g available carbohydrate
Experimental: Arabinoxylan
Bread with Purified arabinoxylan
Other: Bread types
Bread with 50 g available carbohydrate

Primary Outcome Measures :
  1. Glycaemic index of breads with arabinoxylan and beta-glucan compared with whole grain breads in subject with the metabolic syndrome [ Time Frame: 4,5 hours ]

Secondary Outcome Measures :
  1. Glycemic response and satiety [ Time Frame: 4,5 hours ]
    glycemic load, insulin index, glucose, insulin, incretins, inflammatory markers, rate of gastric emptying, metabolomics, and satiety feeling

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • central obesity (Female > 94 cm; Male > 80 cm) with two of the following: -- fasting triglyceride (> 1,7 mmol/L)

    • HDL-cholesterol: (Female: < 1,03 mmol/L; Male: < 1,29 mmol/L)
    • blood pressure (≥ 130/85 mmHg)
    • fasting plasma glucose (≥ 5,6 mmol/L)) Subjects who are in medical treatment with lipid and blood pressure-lowering drugs can continue with their habitual treatment provided that the treatment is stable throughout the trial.

Exclusion Criteria:

  • fasting plasma glucose > 7,0 mmol/l
  • fasting plasma triglyceride > 5,0 mmol/l
  • blood pressure > 160/100 mmHg
  • legal incapacity
  • endocrine, cardiovascular or kidney disease
  • BMI > 38kg/m2
  • corticosteroid treatment
  • alcohol or drug addiction
  • pregnancy or lactation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01316354

Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
University of Aarhus
Principal Investigator: Kjeld Hermansen, Professor Aarhus University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AnneMarie Kruse, Professor Kjeld Hermansen, Aarhus University Hospital Identifier: NCT01316354     History of Changes
Other Study ID Numbers: CERN-BioFunCarb
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: April 19, 2012
Last Verified: April 2012

Keywords provided by AnneMarie Kruse, Aarhus University Hospital:
Beta glucan
Whole grain
Dietary fibre
Metabolic syndrome
Glycemic index

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases