Intervention With Legume Kernel Fibre in Healthy Subjects
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Healthy |
Dietary Supplement: pure fibre-product Dietary Supplement: reference fibre |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Comparison of the Effects of Three Native Legume Kernel Fibres on Cholesterol Metabolism in Healthy Subjects |
- Changes of serum lipids (cholesterol metabolism) [ Time Frame: after 2, 4 and 8 weeks ] [ Designated as safety issue: Yes ]
- Changes of general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion [ Time Frame: after 2, 4 and 8 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 76 |
| Study Start Date: | July 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TypTop
Lupinus albus Typ Top (lupin kernel fibre, dietary fibre content: 83%)
|
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.
Other Names:
|
|
Experimental: Soy fibre
Glycine max Hefeng (soy fibre; dietary fibre content: 77%)
|
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.
Other Names:
|
|
Experimental: Boregine
Lupinus angustifolius Boregine (lupin kernel fibre, dietary fibre content: 87%)
|
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.
Other Names:
|
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| Ages Eligible for Study: | 20 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Germany | |
| Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology | |
| Jena, Thuringia, Germany, D-07743 | |
| Principal Investigator: | Gerhard Jahreis, Prof. Dr. | Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology |
More Information
No publications provided
| Responsible Party: | Prof. Dr. G. Jahreis, Friedrich Schiller University Jena, Department of Nutritional Physiology |
| ClinicalTrials.gov Identifier: | NCT01036308 History of Changes |
| Other Study ID Numbers: | LSEP H32-07 |
| Study First Received: | December 17, 2009 |
| Last Updated: | November 5, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Jena:
|
dietary fibre legumes lupin kernel fibre soy fibre |
bile acids short-chain fatty acids cholesterol metabolism Subjects |
ClinicalTrials.gov processed this record on May 23, 2013