Effect of Arabinoxylan and Rye Kernels on Second Meal Responses

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583270
• Other study ID #: CERN-biofuncarb second meal
• Secondary ID: 2101-08-0068
• Status: Completed
• Phase: N/A
• First received: April 18, 2012
• Last updated: June 18, 2013
• Start date: April 2012
• Est. completion date: October 2012

Study information

• Verified date: June 2013
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Dietary Supplement:
• Arabinoxylan
Porridge rich in arabinoxylan
• Rye kernel
Porridge made of rye kernels
• Arabinoxylan and rye kernels
Porridgde made of rye kernels and arabinoxylan
• Semolina
Semoline porridge. control meal.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose response after second meal		2 hours	No
Secondary	Plasma response after second meal	Plasma insulin, incretins, ghrelin, short chain fatty acids, freee fatty acids, inflammation markers, and metabolomics.	2 hours	No
Secondary	Plasma response after test meal	Plasma glucose, insulin, incretins, short chain fatty acids, free fatty acids, metabolomisc.	2 hours	No
Secondary	Breath hydrogen after second meal	Breath hydrogen as marker for colon fermentation	2 hours	No
Secondary	Breath hydrogen after testmeal	Breath hydrogen as marker for colen fermentation	2 hours	No
Secondary	Satiety feeling after second meal		2 hours	No
Secondary	Satiety feeling after test meal		2 hours	No