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Intervention With Lupin Kernel Fibre in Hypercholesterolemic Subjects

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EstadoTerminado
Patrocinadores
University of Jena
Colaboradores
German Federal Ministry of Education and Research

Palabras clave

Abstracto

The objective of the conducted study was to determine the efficacy of lupin kernel fibre-enriched food (Lupinus angustifolius Boregine) on prevention of risk factors for gastrointestinal or cardiovascular diseases.

Descripción

Dietary fibre is suspected to effect the faecal concentration and excretion of bile acids by binding the bile acids and by increasing the faecal mass. Bile acids, especially the secondary bile acids, are potential risk factors for colorectal cancer. A high bile acid-binding ability of fibre could lead to lower blood cholesterol concentrations by interrupting the enterohepatic circulation. There is evidence that the consumption of lupin kernel fibre, containing both soluble and insoluble fibre fractions, may beneficially modify bowel health.

A total of 133 subjects were recruited for this study. Sixty moderate hypercholesterolemic volunteers (total cholesterol > 5.2 mmol/L) fulfilled the selection criteria and were randomly assigned three groups. Forty-five subjects (mean age of 47 years, 34 women and 20 men) completed the double-blind, randomized crossover trial.

The subjects consumed a high-fibre diet containing 25 g fibre (citrus- or lupin fibre) per day and a low-fibre diet (placebo) for four weeks each. After baseline, each volunteer had to pass all three periods in different order with a two-week wash-out period between each.

At the end of each intervention period, subjects consumed a standardized diet for three days. Furthermore, a quantitative stool collection took place and fasting blood samples were drawn.

fechas

Verificado por última vez: 11/30/2012
Primero enviado: 12/16/2009
Inscripción estimada enviada: 12/16/2009
Publicado por primera vez: 12/17/2009
Última actualización enviada: 12/03/2012
Última actualización publicada: 12/04/2012
Fecha de inicio real del estudio: 05/31/2008
Fecha estimada de finalización primaria: 11/30/2008
Fecha estimada de finalización del estudio: 11/30/2008

Condición o enfermedad

Hypercholesterolemia

Intervención / tratamiento

Dietary Supplement: fabricated food

Fase

-

Grupos de brazos

BrazoIntervención / tratamiento
Experimental: Boregine
Intervention: Lupinus angustifolius Boregine; 25 g lupin kernel fibre per day over 4 weeks; lupin kernel fibre was incorporated in different food
Active Comparator: Reference
Intervention: Reference fibre (citrus fibre: Herbacel AQ Plus; Herbafood ingredients); 25 g citrus fibre per day over 4 weeks; the citrus fibre was incorporated in different food
Placebo Comparator: Placebo
different food without added fibre

Criterio de elegibilidad

Edades elegibles para estudiar 20 Years A 20 Years
Sexos elegibles para estudiarAll
Acepta voluntarios saludablessi
Criterios

Inclusion Criteria:

- moderate Hypercholesterolemia (total cholesterol > 5.2 mmol/L)

- age 20-75 years

Exclusion Criteria:

- intake of lipid-lowering pharmaceuticals

- intake of nutritional supplements

- allergy against legumes

- intolerance against milk protein

- pregnancy, lactation

- chronic bowel diseases

Salir

Medidas de resultado primarias

1. cholesterol metabolism (blood lipids) [after 1, 5, 10 and 15 weeks]

Medidas de resultado secundarias

1. general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion, cytotoxicity, genotoxicity [after 1, 5, 10 and 15 weeks]

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