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Effect of Arabinoxylan and Rye Kernels on Second Meal Responses

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: NCT01583270
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : June 19, 2013
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. 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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Arabinoxylan Dietary Supplement: Rye kernel Dietary Supplement: Arabinoxylan and rye kernels Dietary Supplement: Semolina Not Applicable

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.

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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 Rye Kernels on Second Meal Responses in Subjects With the Metabolic Syndrome
Study Start Date : April 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arabinoxylan
Porridge rich in arabinoxylan. 50 g available carbohydrate
Dietary Supplement: Arabinoxylan
Porridge rich in arabinoxylan
Other Name: Dietary fibre.

Experimental: rye kernels
Porridge made from rye kernels. 50 g available carbohydrate
Dietary Supplement: Rye kernel
Porridge made of rye kernels
Other Name: Whole grain. Rye. Kernels.

Experimental: arabinoxylan and rye kernels
Porridge made of rye kernels and arabinoxylan. 50g available carbohydrate
Dietary Supplement: Arabinoxylan and rye kernels
Porridgde made of rye kernels and arabinoxylan
Other Name: dietary fibre. whole grain. rye kernels.

Experimental: semolina
Semoline porridge. 50 g available carbohydrate
Dietary Supplement: Semolina
Semoline porridge. control meal.
Other Name: Wheat.

Primary Outcome Measures :
  1. Glucose response after second meal [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. Plasma response after second meal [ Time Frame: 2 hours ]
    Plasma insulin, incretins, ghrelin, short chain fatty acids, freee fatty acids, inflammation markers, and metabolomics.

  2. Plasma response after test meal [ Time Frame: 2 hours ]
    Plasma glucose, insulin, incretins, short chain fatty acids, free fatty acids, metabolomisc.

  3. Breath hydrogen after second meal [ Time Frame: 2 hours ]
    Breath hydrogen as marker for colon fermentation

  4. Breath hydrogen after testmeal [ Time Frame: 2 hours ]
    Breath hydrogen as marker for colen fermentation

  5. Satiety feeling after second meal [ Time Frame: 2 hours ]
  6. Satiety feeling after test meal [ Time Frame: 2 hours ]

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

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.

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): NCT01583270

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Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
University of Aarhus
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Principal Investigator: Kjeld Hermansen, Professor Aarhus University Hospital
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Responsible Party: AnneMarie Kruse, Professor Kjeld Hermansen, Aarhus University Hospital Identifier: NCT01583270    
Other Study ID Numbers: CERN-biofuncarb second meal
2101-08-0068 ( Other Grant/Funding Number: Danish council for strategic research )
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013
Keywords provided by AnneMarie Kruse, Aarhus University Hospital:
Rye kernels
whole grain
Dietary fibre
Metabolic syndrome
Glycemic response
Colon fermentation
Second meal effekt
Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases