Trials / Completed
CompletedNCT01036308
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- University of Jena · Academic / Other
- Sex
- All
- Age
- 20 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | pure 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_SUPPLEMENT | reference 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. |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2007-12-01
- Completion
- 2007-12-01
- First posted
- 2009-12-21
- Last updated
- 2012-11-06
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01036308. Inclusion in this directory is not an endorsement.