Effect of Arabinoxylan and Rye Kernels on Second Meal Responses

Study Overview
=================
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.

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

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Arabinoxylan
* Dietary Supplement: Rye kernel
* Dietary Supplement: Arabinoxylan and rye kernels
* Dietary Supplement: Semolina


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arabinoxylan<br>Porridge rich in arabinoxylan. 50 g available carbohydrate | Dietary Supplement: Arabinoxylan<br>* Porridge rich in arabinoxylan<br>* Other names: Dietary fibre.;|
| Experimental: rye kernels<br>Porridge made from rye kernels. 50 g available carbohydrate | Dietary Supplement: Rye kernel<br>* Porridge made of rye kernels<br>* Other names: Whole grain. Rye. Kernels.;|
| Experimental: arabinoxylan and rye kernels<br>Porridge made of rye kernels and arabinoxylan. 50g available carbohydrate | Dietary Supplement: Arabinoxylan and rye kernels<br>* Porridgde made of rye kernels and arabinoxylan<br>* Other names: dietary fibre. whole grain. rye kernels.;|
| Experimental: semolina<br>Semoline porridge. 50 g available carbohydrate | Dietary Supplement: Semolina<br>* Semoline porridge. control meal.<br>* Other names: Wheat.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose response after second meal |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma response after second meal | Plasma insulin, incretins, ghrelin, short chain fatty acids, freee fatty acids, inflammation markers, and metabolomics. | 2 hours | 
| Plasma response after test meal | Plasma glucose, insulin, incretins, short chain fatty acids, free fatty acids, metabolomisc. | 2 hours | 
| Breath hydrogen after second meal | Breath hydrogen as marker for colon fermentation | 2 hours | 
| Breath hydrogen after testmeal | Breath hydrogen as marker for colen fermentation | 2 hours | 
| Satiety feeling after second meal |  | 2 hours | 
| Satiety feeling after test meal |  | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Satiety, Arabinxylan, Rye kernels, whole grain, Dietary fibre, Metabolic syndrome, Glycemic response, Colon fermentation, Second meal effekt