Intervention With Lupin Kernel Fibre in Hypercholesterolemic Subjects

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035086
• Other study ID #: LSEP H36-08
• Status: Completed
• Phase: N/A
• First received: December 17, 2009
• Last updated: December 4, 2012
• Start date: June 2008
• Est. completion date: December 2008

Study information

• Verified date: December 2012
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

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.

Locations

Country	Name	City	State
Germany	Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology	Jena	Thuringia

Sponsors (2)

Lead Sponsor	Collaborator
University of Jena	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cholesterol metabolism (blood lipids)		after 1, 5, 10 and 15 weeks	Yes
Secondary	general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion, cytotoxicity, genotoxicity		after 1, 5, 10 and 15 weeks	Yes