Intervention With Legume Kernel Fibre in Healthy Subjects

Study Overview
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Brief Summary
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The objective of the conducted study was to determine the efficacy of the native legume kernel fibres of Lupinus angustifolius Boregine (Boregine), Lupinus albus Typ Top (TypTop) and Glycine max Hefeng (Soy fibre) on prevention of risk factors for gastrointestinal or cardiovascular diseases.

Detailed Description
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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 serum cholesterol concentrations by interrupting the enterohepatic circulation. There is evidence that the consumption of legume kernel fibre, containing both soluble and insoluble fibre fractions, may beneficially modify bowel health. Seventy-eight healthy volunteers were enrolled. Seventy-six subjects (mean age of 24 years, 55 women and 21 men) completed the double-blind, randomized crossover trial. After two weeks run-in period, half of the volunteers consumed 25 g of legume fibres (Boregine, TypTop or Soy fibre) every day, and the other half received a reference fibre product (citrus fibre, Herbacel AQ Plus) for a period of two weeks. After two weeks wash-out the intervention changed between the groups. At the end of each period a quantitative stool and urine collection took place and fasting blood samples were drawn.

Official Title
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Comparison of the Effects of Three Native Legume Kernel Fibres on Cholesterol Metabolism in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: pure fibre-product
* Dietary Supplement: reference fibre


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 20-45 years healthy subjects Exclusion Criteria: intake of pharmaceuticals and nutritional supplements allergy against legumes intolerance against milk protein pregnancy, lactation chronic diseases

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TypTop<br>Lupinus albus Typ Top (lupin kernel fibre, dietary fibre content: 83%) | Dietary Supplement: pure fibre-product<br>* The subjects consumed 25 g pure fibre-product per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.<br>Dietary Supplement: reference fibre<br>* The subjects consumed 25 g reference fibre (citrus fibre: Herbacel AQ Plus; Herbafood Ingredients) per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.<br>* Other names: citrus fibre;|
| Experimental: Soy fibre<br>Glycine max Hefeng (soy fibre; dietary fibre content: 77%) | Dietary Supplement: pure fibre-product<br>* The subjects consumed 25 g pure fibre-product per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.<br>Dietary Supplement: reference fibre<br>* The subjects consumed 25 g reference fibre (citrus fibre: Herbacel AQ Plus; Herbafood Ingredients) per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.<br>* Other names: citrus fibre;|
| Experimental: Boregine<br>Lupinus angustifolius Boregine (lupin kernel fibre, dietary fibre content: 87%) | Dietary Supplement: pure fibre-product<br>* The subjects consumed 25 g pure fibre-product per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.<br>Dietary Supplement: reference fibre<br>* The subjects consumed 25 g reference fibre (citrus fibre: Herbacel AQ Plus; Herbafood Ingredients) per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.<br>* Other names: citrus fibre;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of serum lipids (cholesterol metabolism) |  | after 2, 4 and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion |  | after 2, 4 and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary fibre, legumes, lupin kernel fibre, soy fibre, bile acids, short-chain fatty acids, cholesterol metabolism, Subjects