Intervention With Legume Kernel Fibre in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT01036308
First received: December 17, 2009
Last updated: November 5, 2012
Last verified: December 2009
  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

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • Changes of serum lipids (cholesterol metabolism) [ Time Frame: after 2, 4 and 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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:
  • Herbacel AQ Plus
  • citrus fibre
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:
  • Herbacel AQ Plus
  • citrus fibre
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:
  • Herbacel AQ Plus
  • citrus fibre

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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01036308

Locations
Germany
Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
Jena, Thuringia, Germany, D-07743
Sponsors and Collaborators
University of Jena
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Gerhard Jahreis, Prof. Dr. Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
  More Information

No publications provided by University of Jena

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 April 16, 2014