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Intervention With Legume Kernel Fibre in Healthy Subjects

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01036308
Enrollment
76
Registered
2009-12-21
Start date
2007-07-31
Completion date
2007-12-31
Last updated
2012-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

dietary fibre, legumes, lupin kernel fibre, soy fibre, bile acids, short-chain fatty acids, cholesterol metabolism, Subjects

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.

Interventions

DIETARY_SUPPLEMENTpure fibre-product

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.

DIETARY_SUPPLEMENTreference fibre

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.

Sponsors

German Federal Ministry of Education and Research
CollaboratorOTHER_GOV
University of Jena
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Changes of serum lipids (cholesterol metabolism)after 2, 4 and 8 weeks

Secondary

MeasureTime frame
Changes of general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretionafter 2, 4 and 8 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026