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Intervention With Lupin Kernel Fibre in Hypercholesterolemic Subjects

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena
ClinicalTrials.gov Identifier:
NCT01035086
First received: December 17, 2009
Last updated: December 4, 2012
Last verified: December 2012

December 17, 2009
December 4, 2012
June 2008
December 2008   (final data collection date for primary outcome measure)
cholesterol metabolism (blood lipids) [ Time Frame: after 1, 5, 10 and 15 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01035086 on ClinicalTrials.gov Archive Site
general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion, cytotoxicity, genotoxicity [ Time Frame: after 1, 5, 10 and 15 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Intervention With Lupin Kernel Fibre in Hypercholesterolemic Subjects
The Preventive Effects of Lupin Kernel Fibre-enriched Food on Colon Cancer and Cardiovascular Diseases in Moderate Hypercholesterolemic Subjects

The objective of the conducted study was to determine the efficacy of lupin kernel fibre-enriched food (Lupinus angustifolius Boregine) on prevention of risk factors for gastrointestinal or cardiovascular diseases.

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 blood cholesterol concentrations by interrupting the enterohepatic circulation. There is evidence that the consumption of lupin kernel fibre, containing both soluble and insoluble fibre fractions, may beneficially modify bowel health.

A total of 133 subjects were recruited for this study. Sixty moderate hypercholesterolemic volunteers (total cholesterol > 5.2 mmol/L) fulfilled the selection criteria and were randomly assigned three groups. Forty-five subjects (mean age of 47 years, 34 women and 20 men) completed the double-blind, randomized crossover trial.

The subjects consumed a high-fibre diet containing 25 g fibre (citrus- or lupin fibre) per day and a low-fibre diet (placebo) for four weeks each. After baseline, each volunteer had to pass all three periods in different order with a two-week wash-out period between each.

At the end of each intervention period, subjects consumed a standardized diet for three days. Furthermore, a quantitative stool collection took place and fasting blood samples were drawn.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Hypercholesterolemia
Dietary Supplement: fabricated food
The subjects consumed a high-fibre diet containing 25 g fibre (citrus- or lupin fibre) per day and a low-fibre diet (placebo) for four weeks each. After a one-week run-in period, each volunteer had to pass all three periods (arms) in different order with a two-week wash-out period between each.
Other Name: diet
  • Experimental: Boregine
    Intervention: Lupinus angustifolius Boregine; 25 g lupin kernel fibre per day over 4 weeks; lupin kernel fibre was incorporated in different food
    Intervention: Dietary Supplement: fabricated food
  • Active Comparator: Reference
    Intervention: Reference fibre (citrus fibre: Herbacel AQ Plus; Herbafood ingredients); 25 g citrus fibre per day over 4 weeks; the citrus fibre was incorporated in different food
    Intervention: Dietary Supplement: fabricated food
  • Placebo Comparator: Placebo
    different food without added fibre
    Intervention: Dietary Supplement: fabricated food
Fechner A, Kiehntopf M, Jahreis G. The formation of short-chain fatty acids is positively associated with the blood lipid-lowering effect of lupin kernel fiber in moderately hypercholesterolemic adults. J Nutr. 2014 May;144(5):599-607. doi: 10.3945/jn.113.186858. Epub 2014 Feb 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • moderate Hypercholesterolemia (total cholesterol > 5.2 mmol/L)
  • age 20-75 years

Exclusion Criteria:

  • intake of lipid-lowering pharmaceuticals
  • intake of nutritional supplements
  • allergy against legumes
  • intolerance against milk protein
  • pregnancy, lactation
  • chronic bowel diseases
Both
20 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01035086
LSEP H36-08
Yes
Gerhard Jahreis, University of Jena
University of Jena
German Federal Ministry of Education and Research
Principal Investigator: Gerhard Jahreis, Prof. Dr. Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
University of Jena
December 2012

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