Intervention With Lupin Kernel Fibre in Hypercholesterolemic Subjects

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: fabricated food

• Registration Number: NCT01035086
• Lead Sponsor: University of Jena

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.

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2009-12-17
• Study First Submitted QC: 2009-12-17
• Study First Posted: 2009-12-18
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-04
• Last Update Posted: 2012-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Boregine	fabricated food	Intervention: Lupinus angustifolius Boregine; 25 g lupin kernel fibre per day over 4 weeks; lupin kernel fibre was incorporated in different food
Reference	fabricated food	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
Placebo	fabricated food	different food without added fibre

Primary Outcome Measures

Name	Time	Method
cholesterol metabolism (blood lipids)	after 1, 5, 10 and 15 weeks

Secondary Outcome Measures

Name	Time	Method
general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion, cytotoxicity, genotoxicity	after 1, 5, 10 and 15 weeks

Trial Locations

Locations (1)

Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology; 🇩🇪 Jena, Thuringia, Germany