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Intervention With Legume Kernel Fibre in Healthy Subjects

U

University of Jena

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: pure fibre-product
Dietary Supplement: reference fibre

Study type

Interventional

Funder types

Other

Identifiers

NCT01036308
LSEP H32-07

Details and patient eligibility

About

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.

Full 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.

Enrollment

76 patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

76 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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