ButCoIns - Metabolic Effects of Resistent Starch and Arabinoxylans in Subjects With Metabolic Syndrome (ButCoIns)
Background Life style related disease is an increasing problem all over the world. The Metabolic Syndrome (MetS) is a condition characterized by abdominal obesity, high blood lipids, high blood pressure and slightly elevated blood sugar. Subjects with MetS have high risk of developing Type 2 Diabetes and cardiovascular disease.
Dietary fibers have been shown to have positive effects on the components of MetS. The investigators have special interest in the combination of two types of fiber (Resistant (RS) starch and Arabinoxylans (AX)) .
Hypotheses Increase of RS and AX in the dietary composition has a positive effects on components of MetS i.e. decreases blood lipids, improves blood sugar, blood pressure and markers of inflammation.
The subjects undergo two dietary interventions of 4 weeks duration each: A "Healthy Carbohydrate Diet" with a high content of RS and AX is compared to a "Western Style Diet" with a low content of RS and AX.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Background Life style related disease is an increasing problem all over the world. The Metabolic Syndrome (MetS) is a condition characterized by abdominal obesity, dyslipidemia, hypertension and impaired glucose tolerance. Subjects with MetS have high risk of developing Type 2 Diabetes and CVD.
Resistant Starch (RS) and Arabinoxylans (AX) are dietary fibers that have been shown to have positive effects on the components of MetS. The combination of RS and AX has not been tested before .
Hypotheses Increase of RS and AX in the dietary composition has a positive effects on components of MetS i.e. decreases postprandial lipaemia, improves glucose tolerance, insulin resistance, blood pressure and markers of inflammation.
Design:
A nonblinded randomized cross over study Two dietary interventions of 4 weeks duration each. A healthy carbohydrate Diet with a high content of RS and AX is compared to a Western Style diet with a low content of RS and AX. Between the two interventions, there is a wash out period of 4 weeks.
The primary outcome is postprandial lipaemia estimated by a high fat meal test of 6 hours duration. The test is performed before and after each intervention.
Secondary outcomes are:
- Glucose tolerance and insulin resistance estimated by OGTT
- 24 hours blood pressure
- MRI estimation of liver fat content
- Postprandial changes in genes of adipose tissue
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Aarhus, Dania, 8000
- Aarhus University Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria: At least 3 out of the 5 following criterions
- Central obesity (Female >80 cm, Male >94)
- HDL cholesterol (female < 1,03 mmol/l, male < 1,29 mmol/l)
- Blood Pressure (> 130/85)
- Fasting Blood Glucose > 5,6 mmol/L
Exclusion Criteria:
- Diabetes
- Gastrointestinal disease
- Anticoagulation treatment
- Serious liver, heart or kidney disease
- Anaemia
- Corticosteroid treatment
- Waist circumference above 130 cm
- Alcohol or drug addiction
- Pregnancy og lactation
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: Healthy Carbohydrate Diet
4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch.
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Cross over study with two intervention diets.
Healthy Carbohydrate Diet with approximally 55 g of dietary fibers (arabinoxylan and resistant starch)compared with western style diet with low content of dietary fibers.
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Komparator placebo: Western Style Diet
4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans
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Cross over study with two intervention diets.
Healthy Carbohydrate Diet with approximally 55 g of dietary fibers (arabinoxylan and resistant starch)compared with western style diet with low content of dietary fibers.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Postprandial triglycerides
Ramy czasowe: 4 weeks
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Plasma Triglycerides are estimated during a high fat meal test of 6 hours duration.
The test is performed before and after each intervention of 4 weeks.
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4 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in insulin sensitivity
Ramy czasowe: 4 weeks
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-Estimated by an OGTT where glucose and insulin are measured several times and insulin sensitivity is estimated according to the Matsuda Index.
The test is performed before and after each intervention of 4 weeks.
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4 weeks
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Metabolic Rate
Ramy czasowe: 4 weeks
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The metabolic rate is measured by indirect calometri (Deltatrac II) in the fasting state and two hours after ingestion of a fatty mixed meal.
The test is performed before and after each intervention period.
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4 weeks
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Body composition
Ramy czasowe: 4 weeks
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H-MRS of liver before and after intervention in order to estimate the fat content.
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4 weeks
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Twenty-Four-Hour Blood Pressure
Ramy czasowe: 4 weeks
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Performed in the free-living situation.
Data analysis are grouped in mean day, mean night and mean 24 h.
Measured at baseline and at the end of each intervention.
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4 weeks
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Gene expression in adipose tissue
Ramy czasowe: Four weeks
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Fat biopsies are take from abdominal adipose tissue and analyzed by real time PCR to see if gene expression changes after a high intake of dietary fiber.
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Four weeks
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Inflammatory Markers after 4 weeks of intervention
Ramy czasowe: 4 weeks
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hs CRP, IL-6 and adiponectin are measured at baseline and at the end of each intervention.
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4 weeks
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Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CERN-ButCoIns
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