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

March 15, 2011
April 18, 2012
August 2011
December 2011   (final data collection date for primary outcome measure)
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 ]
Glycaemic index of breads with arabinoxylan and beta-glucan compared with whole grain breads in subject with the metabolic syndrome [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01316354 on ClinicalTrials.gov Archive Site
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
Glycemic response and satiety [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
glycemic load, insulin index, glucose, insulin, incretins, rate of gastric emptying, metabolomics, and satiety feeling
Not Provided
Not Provided
 
Effect of Dietary Fibre and Whole Grain on the Metabolic Syndrome
Effect of Arabinoxylan and Beta-glucan Compared With Whole Grain and Whole Meal Bread in Subjects With the Metabolic Syndrome

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Metabolic Syndrome
Other: Bread types
Bread with 50 g available carbohydrate
  • Experimental: Beta-glucan
    Bread with purified beta-glucan
    Intervention: Other: Bread types
  • Experimental: Rye kernels
    Rye bread with kernels
    Intervention: Other: Bread types
  • Experimental: White bread
    White bread
    Intervention: Other: Bread types
  • Experimental: Arabinoxylan
    Bread with Purified arabinoxylan
    Intervention: Other: Bread types
Nielsen KL, Hartvigsen ML, Hedemann MS, Lærke HN, Hermansen K, Bach Knudsen KE. Similar metabolic responses in pigs and humans to breads with different contents and compositions of dietary fibers: a metabolomics study. Am J Clin Nutr. 2014 Apr;99(4):941-9. doi: 10.3945/ajcn.113.074724. Epub 2014 Jan 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01316354
CERN-BioFunCarb
Yes
AnneMarie Kruse, Aarhus University Hospital
Aarhus University Hospital
University of Aarhus
Principal Investigator: Kjeld Hermansen, Professor Aarhus University Hospital
Aarhus University Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP