Clinical trial NCT01035086: Intervention With Lupin Kernel Fibre in Hypercholesterolemic Subjects
Official title: The Preventive Effects of Lupin Kernel Fibre-enriched Food on Colon Cancer and Cardiovascular Diseases in Moderate Hypercholesterolemic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: dietary fibre
lupin kernel fibre
bile acids
cholesterol metabolism
blood lipids
hypercholesterolemia
fibre-enriched food
moderate hypercholesterolemia
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2009-12-18
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: cholesterol metabolism (blood lipids)
timeFrame: after 1, 5, 10 and 15 weeks
Secondary outcomes:
measure: general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion, cytotoxicity, genotoxicity
timeFrame: after 1, 5, 10 and 15 weeks
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
state: Thuringia
Study officials:
affiliation: Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
name: Gerhard Jahreis, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.