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The Preventive Effects of Lupin Kernel Fibre-enriched Food on Colon Cancer and Cardiovascular Diseases in Moderate Hypercholesterolemic Subjects


N/A
20 Years
75 Years
Not Enrolling
Both
Hypercholesterolemia

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Trial Information

The Preventive Effects of Lupin Kernel Fibre-enriched Food on Colon Cancer and Cardiovascular Diseases in Moderate Hypercholesterolemic Subjects


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

cholesterol metabolism (blood lipids)

Outcome Time Frame:

after 1, 5, 10 and 15 weeks

Safety Issue:

Yes

Principal Investigator

Gerhard Jahreis, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology

Authority:

Germany: Ethics Commission

Study ID:

LSEP H36-08

NCT ID:

NCT01035086

Start Date:

June 2008

Completion Date:

December 2008

Related Keywords:

  • Hypercholesterolemia
  • dietary fibre
  • lupin kernel fibre
  • bile acids
  • cholesterol metabolism
  • blood lipids
  • hypercholesterolemia
  • fibre-enriched food
  • moderate hypercholesterolemia
  • Cardiovascular Diseases
  • Hypercholesterolemia

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