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Effect of Arabinoxylan and Rye Kernels on Second Meal Responses

This study has been completed.
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
AnneMarie Kruse, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01583270
First received: April 18, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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 Intervention
Metabolic Syndrome
Dietary Supplement: Arabinoxylan
Dietary Supplement: Rye kernel
Dietary Supplement: Arabinoxylan and rye kernels
Dietary Supplement: Semolina

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Arabinoxylan and Rye Kernels on Second Meal Responses in Subjects With the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Glucose response after second meal [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma response after second meal [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Plasma insulin, incretins, ghrelin, short chain fatty acids, freee fatty acids, inflammation markers, and metabolomics.

  • Plasma response after test meal [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Plasma glucose, insulin, incretins, short chain fatty acids, free fatty acids, metabolomisc.

  • Breath hydrogen after second meal [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Breath hydrogen as marker for colon fermentation

  • Breath hydrogen after testmeal [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Breath hydrogen as marker for colen fermentation

  • Satiety feeling after second meal [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Satiety feeling after test meal [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: April 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583270

Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
University of Aarhus
Investigators
Principal Investigator: Kjeld Hermansen, Professor Aarhus University Hospital
  More Information

No publications provided

Responsible Party: AnneMarie Kruse, Professor Kjeld Hermansen, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01583270     History of Changes
Other Study ID Numbers: CERN-biofuncarb second meal, 2101-08-0068
Study First Received: April 18, 2012
Last Updated: June 18, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Aarhus University Hospital:
Arabinxylan
Rye kernels
whole grain
Dietary fibre
Metabolic syndrome
Glycemic response
Colon fermentation
Second meal effekt
Satiety

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 19, 2014