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NCT Number: NCT01583270

Effect of Arabinoxylan and Rye Kernels on Second Meal Responses

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arabinoxylan

Dietary Supplement

Porridge rich in arabinoxylan

Other names: Dietary fibre.

Rye kernel

Dietary Supplement

Porridge made of rye kernels

Other names: Whole grain. Rye. Kernels.

Arabinoxylan and rye kernels

Dietary Supplement

Porridgde made of rye kernels and arabinoxylan

Other names: dietary fibre. whole grain. rye kernels.

Semolina

Dietary Supplement

Semoline porridge. control meal.

Other names: Wheat.

Primary outcomes

  1. Glucose response after second meal

    Time frame: 2 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • University of Aarhus

Registry information

Official study title

Effect of Arabinoxylan and Rye Kernels on Second Meal Responses in Subjects With the Metabolic Syndrome

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 24, 2012
Registry last updated
Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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