Intervention With Legume Kernel Fibre in Healthy Subjects

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: pure fibre-product; Dietary Supplement: reference fibre

• Registration Number: NCT01036308
• Lead Sponsor: University of Jena

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2009-12
• Study First Submitted: 2009-12-17
• Study First Submitted QC: 2009-12-18
• Study First Posted: 2009-12-21
• Last Update Submitted: 2012-11-05
• Last Update Posted: 2012-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TypTop	pure fibre-product	Lupinus albus Typ Top (lupin kernel fibre, dietary fibre content: 83%)
TypTop	reference fibre	Lupinus albus Typ Top (lupin kernel fibre, dietary fibre content: 83%)
Soy fibre	pure fibre-product	Glycine max Hefeng (soy fibre; dietary fibre content: 77%)
Soy fibre	reference fibre	Glycine max Hefeng (soy fibre; dietary fibre content: 77%)
Boregine	pure fibre-product	Lupinus angustifolius Boregine (lupin kernel fibre, dietary fibre content: 87%)
Boregine	reference fibre	Lupinus angustifolius Boregine (lupin kernel fibre, dietary fibre content: 87%)

Primary Outcome Measures

Name	Time	Method
Changes of serum lipids (cholesterol metabolism)	after 2, 4 and 8 weeks

Secondary Outcome Measures

Name	Time	Method
Changes of general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion	after 2, 4 and 8 weeks

Trial Locations

Locations (1)

Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology; 🇩🇪 Jena, Thuringia, Germany