Effect of Dietary Fibre and Whole Grain on the Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
AnneMarie Kruse, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01316354
First received: March 15, 2011
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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 Intervention
Metabolic Syndrome
Other: Bread types

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycemic response and satiety [ Time Frame: 4,5 hours ] [ Designated as safety issue: No ]
    glycemic load, insulin index, glucose, insulin, incretins, inflammatory markers, rate of gastric emptying, metabolomics, and satiety feeling


Enrollment: 15
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316354

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

No publications provided by Aarhus University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AnneMarie Kruse, Professor Kjeld Hermansen, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01316354     History of Changes
Other Study ID Numbers: CERN-BioFunCarb
Study First Received: March 15, 2011
Last Updated: April 18, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Aarhus University Hospital:
Arabinoxylan
Beta glucan
Whole grain
Dietary fibre
Metabolic syndrome
Glycemic index
Satiety

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

ClinicalTrials.gov processed this record on August 19, 2014