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Intervention With Legume Kernel Fibre in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01036308
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : November 6, 2012
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
University of Jena

Tracking Information
First Submitted Date  ICMJE December 17, 2009
First Posted Date  ICMJE December 21, 2009
Last Update Posted Date November 6, 2012
Study Start Date  ICMJE July 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2012)
Changes of serum lipids (cholesterol metabolism) [ Time Frame: after 2, 4 and 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2009)
cholesterol metabolism (serum lipids) [ Time Frame: after 2, 4 and 8 weeks ]
Change History Complete list of historical versions of study NCT01036308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2012)
Changes of general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion [ Time Frame: after 2, 4 and 8 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2009)
general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion [ Time Frame: after 2, 4 and 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intervention With Legume Kernel Fibre in Healthy Subjects
Official Title  ICMJE Comparison of the Effects of Three Native Legume Kernel Fibres on Cholesterol Metabolism in Healthy 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: TypTop
    Lupinus albus Typ Top (lupin kernel fibre, dietary fibre content: 83%)
    Interventions:
    • Dietary Supplement: pure fibre-product
    • Dietary Supplement: reference fibre
  • Experimental: Soy fibre
    Glycine max Hefeng (soy fibre; dietary fibre content: 77%)
    Interventions:
    • Dietary Supplement: pure fibre-product
    • Dietary Supplement: reference fibre
  • Experimental: Boregine
    Lupinus angustifolius Boregine (lupin kernel fibre, dietary fibre content: 87%)
    Interventions:
    • Dietary Supplement: pure fibre-product
    • Dietary Supplement: reference fibre
Publications * Fechner A, Fenske K, Jahreis G. Effects of legume kernel fibres and citrus fibre on putative risk factors for colorectal cancer: a randomised, double-blind, crossover human intervention trial. Nutr J. 2013 Jul 16;12:101. doi: 10.1186/1475-2891-12-101.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2009)
76
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01036308
Other Study ID Numbers  ICMJE LSEP H32-07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. G. Jahreis, Friedrich Schiller University Jena, Department of Nutritional Physiology
Study Sponsor  ICMJE University of Jena
Collaborators  ICMJE German Federal Ministry of Education and Research
Investigators  ICMJE
Principal Investigator: Gerhard Jahreis, Prof. Dr. Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
PRS Account University of Jena
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP