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Effect of Arabinoxylan and Rye Kernels on Second Meal Responses

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Arabinoxylan
Rye kernel
Arabinoxylan and rye kernels
Semolina
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 Arabinxylan, Rye kernels, whole grain, Dietary fibre, Metabolic syndrome, Glycemic response, Colon fermentation, Second meal effekt, 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:

  1. fasting triglyceride (> 1,7 mmol/L),
  2. HDL-cholesterol: (Female:< 1,03 mmol/L; Male:< 1,29 mmol/L),
  3. blood pressure (≥ 130/85 mmHg) and
  4. 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 and
  • 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

Arabinoxylan

rye kernels

arabinoxylan and rye kernels

semolina

Arm Description

Porridge rich in arabinoxylan. 50 g available carbohydrate

Porridge made from rye kernels. 50 g available carbohydrate

Porridge made of rye kernels and arabinoxylan. 50g available carbohydrate

Semoline porridge. 50 g available carbohydrate

Outcomes

Primary Outcome Measures

Glucose response after second meal

Secondary Outcome Measures

Plasma response after second meal
Plasma insulin, incretins, ghrelin, short chain fatty acids, freee fatty acids, inflammation markers, and metabolomics.
Plasma response after test meal
Plasma glucose, insulin, incretins, short chain fatty acids, free fatty acids, metabolomisc.
Breath hydrogen after second meal
Breath hydrogen as marker for colon fermentation
Breath hydrogen after testmeal
Breath hydrogen as marker for colen fermentation
Satiety feeling after second meal
Satiety feeling after test meal

Full Information

First Posted
April 18, 2012
Last Updated
June 18, 2013
Sponsor
Aarhus University Hospital
Collaborators
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01583270
Brief Title
Effect of Arabinoxylan and Rye Kernels on Second Meal Responses
Official Title
Effect of Arabinoxylan and Rye Kernels on Second Meal Responses in Subjects With the Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (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
No

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. Barley, oat and rye may in addition to reducing the acute post prandial glucose response also reduce glucose response at a subsequent meal. Purified dietary fibre has been shown to reduce GI and affect levels of satiety hormones. In contrast, our knowledge of the physiological effect of arabinoxylan, which constitute a substantial part of dietary fibre in cereal products, is limited in relation to second meal effects. The investigators also lack knowledge of the second meal effect of arabinoxyan in combination with rye kernels. Hypothesis: Porridge rich in arabinoxylan and/or whole rye kernels can increase the formation of short chain fatty acids and improve the glycemic response. The aim of the present study is to compare the effect of porridge test meals based on purified arabinoxylan, rye kernels, a combination of arabinoxylan and rye kernels, and semolina porridge as control on acute postprandial response as well as response at a subsequent standardized meal. The study will be conducted in subjects with the metabolic syndrome. The primary endpoint is glucose response. Secondary endpoints are the following items: insulin, incretins, inflammatory markers, ghrelin, free fatty acids, metabolomics, breath hydrogen and subjective satiety feeling. 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, 15 subjects with Mets will consume test meals containing four different porridges in randomized order. Blood samples will be collected over 2 hours after ingestion of test meals and 2 hours after ingestion of a standard second lunch meal served 4 hours after the test meals. The amount of porridge and the standard lunch are equivalent to 50 g available carbohydrate. Visual Analog Scale (VAS) will be used for determination of subjective satiety feeling and measurements of breath hydrogen will be used as a marker for colon fermentation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Arabinxylan, Rye kernels, whole grain, Dietary fibre, Metabolic syndrome, Glycemic response, Colon fermentation, Second meal effekt, 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
Arabinoxylan
Arm Type
Experimental
Arm Description
Porridge rich in arabinoxylan. 50 g available carbohydrate
Arm Title
rye kernels
Arm Type
Experimental
Arm Description
Porridge made from rye kernels. 50 g available carbohydrate
Arm Title
arabinoxylan and rye kernels
Arm Type
Experimental
Arm Description
Porridge made of rye kernels and arabinoxylan. 50g available carbohydrate
Arm Title
semolina
Arm Type
Experimental
Arm Description
Semoline porridge. 50 g available carbohydrate
Intervention Type
Dietary Supplement
Intervention Name(s)
Arabinoxylan
Other Intervention Name(s)
Dietary fibre.
Intervention Description
Porridge rich in arabinoxylan
Intervention Type
Dietary Supplement
Intervention Name(s)
Rye kernel
Other Intervention Name(s)
Whole grain. Rye. Kernels.
Intervention Description
Porridge made of rye kernels
Intervention Type
Dietary Supplement
Intervention Name(s)
Arabinoxylan and rye kernels
Other Intervention Name(s)
dietary fibre. whole grain. rye kernels.
Intervention Description
Porridgde made of rye kernels and arabinoxylan
Intervention Type
Dietary Supplement
Intervention Name(s)
Semolina
Other Intervention Name(s)
Wheat.
Intervention Description
Semoline porridge. control meal.
Primary Outcome Measure Information:
Title
Glucose response after second meal
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Plasma response after second meal
Description
Plasma insulin, incretins, ghrelin, short chain fatty acids, freee fatty acids, inflammation markers, and metabolomics.
Time Frame
2 hours
Title
Plasma response after test meal
Description
Plasma glucose, insulin, incretins, short chain fatty acids, free fatty acids, metabolomisc.
Time Frame
2 hours
Title
Breath hydrogen after second meal
Description
Breath hydrogen as marker for colon fermentation
Time Frame
2 hours
Title
Breath hydrogen after testmeal
Description
Breath hydrogen as marker for colen fermentation
Time Frame
2 hours
Title
Satiety feeling after second meal
Time Frame
2 hours
Title
Satiety feeling after test meal
Time Frame
2 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) and 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 and 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

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