Effect of Arabinoxylan and Rye Kernels on Second Meal Responses

June 18, 2013 updated by: AnneMarie Kruse, Aarhus University Hospital

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

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aarhus, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arabinoxylan
Porridge rich in arabinoxylan. 50 g available carbohydrate
Porridge rich in arabinoxylan
Other Names:
  • Dietary fibre.
Experimental: rye kernels
Porridge made from rye kernels. 50 g available carbohydrate
Porridge made of rye kernels
Other Names:
  • Whole grain. Rye. Kernels.
Experimental: arabinoxylan and rye kernels
Porridge made of rye kernels and arabinoxylan. 50g available carbohydrate
Porridgde made of rye kernels and arabinoxylan
Other Names:
  • dietary fibre. whole grain. rye kernels.
Experimental: semolina
Semoline porridge. 50 g available carbohydrate
Semoline porridge. control meal.
Other Names:
  • Wheat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucose response after second meal
Time Frame: 2 hours
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 hours
Plasma response after test meal
Time Frame: 2 hours
Plasma glucose, insulin, incretins, short chain fatty acids, free fatty acids, metabolomisc.
2 hours
Breath hydrogen after second meal
Time Frame: 2 hours
Breath hydrogen as marker for colon fermentation
2 hours
Breath hydrogen after testmeal
Time Frame: 2 hours
Breath hydrogen as marker for colen fermentation
2 hours
Satiety feeling after second meal
Time Frame: 2 hours
2 hours
Satiety feeling after test meal
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

April 18, 2012

First Submitted That Met QC Criteria

April 23, 2012

First Posted (Estimate)

April 24, 2012

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • CERN-biofuncarb second meal
  • 2101-08-0068 (Other Grant/Funding Number: Danish council for strategic research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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