- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01583270
Effect of Arabinoxylan and Rye Kernels on Second Meal Responses
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
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Aarhus University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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:
|
|
Experimental: rye kernels
Porridge made from rye kernels.
50 g available carbohydrate
|
Porridge made of rye kernels
Other Names:
|
|
Experimental: arabinoxylan and rye kernels
Porridge made of rye kernels and arabinoxylan.
50g available carbohydrate
|
Porridgde made of rye kernels and arabinoxylan
Other Names:
|
|
Experimental: semolina
Semoline porridge.
50 g available carbohydrate
|
Semoline porridge.
control meal.
Other Names:
|
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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.
Clinical Trials on Metabolic Syndrome
-
Sun Yat-sen UniversityNot yet recruitingMetabolic Syndrome Risk Factors | Metabolic Syndrome (MetS)China
-
Meihua JiThe Luhe Teaching Hospital of the Capital Medical UniversityRecruiting
-
Meihua JiThe Luhe Teaching Hospital of the Capital Medical UniversityEnrolling by invitationMetabolic Syndrome (MetS)China
-
National University Health System, SingaporeRecruitingMetabolic Syndrome | Metabolic Syndrome (MetS)Singapore
-
Hacettepe UniversityCompletedMetabolic Syndrome | Metabolic Syndrome Obesity | Metabolic Syndrome ParametersTurkey
-
Universidad de los Andes, ChileCompleted
-
SanofiBristol-Myers SquibbCompletedMetabolic Syndrome xUnited States
-
University of KhartoumMinistry of Higher Education and Scientific Research, Republic of SudanCompletedMetabolic Syndrome in Postmenopausal FemalesSudan
-
University of Central LancashireDoNotAge.orgNot yet recruitingCardiometabolic Syndrome
-
The Catholic University of KoreaCompletedMetabolic Syndrome X | Metabolic Cardiovascular Syndrome | Insulin Resistance Syndrome X | Dysmetabolic Syndrome XKorea, Republic of
Clinical Trials on Arabinoxylan
-
Comet Bio Inc.Biofortis, Merieux NutriSciencesUnknownGastrointestinal Tolerance
-
University of CopenhagenCompletedWeight Loss | Overweight and ObesityDenmark
-
Fugeia NVCompleted
-
KU LeuvenCompleted
-
Purdue UniversityRural Development Administration (RDA) of the Republic of KoreaNot yet recruiting
-
University of MiamiDaiwa Health DevelopmentCompletedHuman Immunodeficiency Virus InfectionUnited States
-
University of Southern CaliforniaCompletedInflammation in HIV InfectionUnited States
-
University of ReadingUnknownOverweight and ObesityUnited Kingdom
-
IRCCS Policlinico S. MatteoUnknownNutritional and Metabolic DiseasesItaly
-
University of AberdeenKarolinska Institutet; Universidad de Murcia; University of Leeds; University of... and other collaboratorsCompletedOverweight and ObesityUnited Kingdom