Intervention With Lupin Kernel Fibre in Hypercholesterolemic Subjects

University of Jena

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: fabricated food

Study type: Interventional

Funder types: Other

Identifiers

NCT01035086

LSEP H36-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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54 participants in 3 patient groups, including a placebo group

Boregine

Experimental group

Description:

Intervention: Lupinus angustifolius Boregine; 25 g lupin kernel fibre per day over 4 weeks; lupin kernel fibre was incorporated in different food

Treatment:

Dietary Supplement: fabricated food

Reference

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: fabricated food

Placebo

Placebo Comparator group

Description:

different food without added fibre

Treatment:

Dietary Supplement: fabricated food