Clinical trial NCT01036308: Intervention With Legume Kernel Fibre in Healthy Subjects
Official title: Comparison of the Effects of Three Native Legume Kernel Fibres on Cholesterol Metabolism in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: dietary fibre
legumes
lupin kernel fibre
soy fibre
bile acids
short-chain fatty acids
cholesterol metabolism
Subjects
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2009-12-21
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes of serum lipids (cholesterol metabolism)
timeFrame: after 2, 4 and 8 weeks
Secondary outcomes:
measure: Changes of general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion
timeFrame: after 2, 4 and 8 weeks
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
state: Thuringia
Study officials:
affiliation: Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
name: Gerhard Jahreis, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fechner A, Fenske K, Jahreis G. Effects of legume kernel fibres and citrus fibre on putative risk factors for colorectal cancer: a randomised, double-blind, crossover human intervention trial. Nutr J. 2013 Jul 16;12:101. doi: 10.1186/1475-2891-12-101.