Intervention With Lupin Kernel Fibre in Hypercholesterolemic Subjects

U

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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