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Effect of Dietary Fibre and Whole Grain on the Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Bread types
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Arabinoxylan, Beta glucan, Whole grain, Dietary fibre, Metabolic syndrome, Glycemic index, Satiety

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Beta-glucan

Rye kernels

White bread

Arabinoxylan

Arm Description

Bread with purified beta-glucan

Rye bread with kernels

White bread

Bread with Purified arabinoxylan

Outcomes

Primary Outcome Measures

Glycaemic index of breads with arabinoxylan and beta-glucan compared with whole grain breads in subject with the metabolic syndrome

Secondary Outcome Measures

Glycemic response and satiety
glycemic load, insulin index, glucose, insulin, incretins, inflammatory markers, rate of gastric emptying, metabolomics, and satiety feeling

Full Information

First Posted
March 15, 2011
Last Updated
April 18, 2012
Sponsor
Aarhus University Hospital
Collaborators
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01316354
Brief Title
Effect of Dietary Fibre and Whole Grain on the Metabolic Syndrome
Official Title
Effect of Arabinoxylan and Beta-glucan Compared With Whole Grain and Whole Meal Bread in Subjects With the Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
Collaborators
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Arabinoxylan, Beta glucan, Whole grain, Dietary fibre, Metabolic syndrome, Glycemic index, Satiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beta-glucan
Arm Type
Experimental
Arm Description
Bread with purified beta-glucan
Arm Title
Rye kernels
Arm Type
Experimental
Arm Description
Rye bread with kernels
Arm Title
White bread
Arm Type
Experimental
Arm Description
White bread
Arm Title
Arabinoxylan
Arm Type
Experimental
Arm Description
Bread with Purified arabinoxylan
Intervention Type
Other
Intervention Name(s)
Bread types
Intervention Description
Bread with 50 g available carbohydrate
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Glycemic response and satiety
Description
glycemic load, insulin index, glucose, insulin, incretins, inflammatory markers, rate of gastric emptying, metabolomics, and satiety feeling
Time Frame
4,5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjeld Hermansen, Professor
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
27387922
Citation
Krishnan S, Hendriks HF, Hartvigsen ML, de Graaf AA. Feed-forward neural network model for hunger and satiety related VAS score prediction. Theor Biol Med Model. 2016 Jul 7;13(1):17. doi: 10.1186/s12976-016-0043-4.
Results Reference
derived
PubMed Identifier
24477039
Citation
Nielsen KL, Hartvigsen ML, Hedemann MS, Laerke 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.
Results Reference
derived

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Effect of Dietary Fibre and Whole Grain on the Metabolic Syndrome

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