Intervention With Legume Kernel Fibre in Healthy Subjects

November 5, 2012 updated by: University of Jena

Comparison of the Effects of Three Native Legume Kernel Fibres on Cholesterol Metabolism in Healthy Subjects

The objective of the conducted study was to determine the efficacy of the native legume kernel fibres of Lupinus angustifolius Boregine (Boregine), Lupinus albus Typ Top (TypTop) and Glycine max Hefeng (Soy fibre) on prevention of risk factors for gastrointestinal or cardiovascular diseases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 serum cholesterol concentrations by interrupting the enterohepatic circulation. There is evidence that the consumption of legume kernel fibre, containing both soluble and insoluble fibre fractions, may beneficially modify bowel health.

Seventy-eight healthy volunteers were enrolled. Seventy-six subjects (mean age of 24 years, 55 women and 21 men) completed the double-blind, randomized crossover trial. After two weeks run-in period, half of the volunteers consumed 25 g of legume fibres (Boregine, TypTop or Soy fibre) every day, and the other half received a reference fibre product (citrus fibre, Herbacel AQ Plus) for a period of two weeks. After two weeks wash-out the intervention changed between the groups.

At the end of each period a quantitative stool and urine collection took place and fasting blood samples were drawn.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Thuringia
      • Jena, Thuringia, Germany, D-07743
        • Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 20-45 years
  • healthy subjects

Exclusion Criteria:

  • intake of pharmaceuticals and nutritional supplements
  • allergy against legumes
  • intolerance against milk protein
  • pregnancy, lactation
  • chronic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TypTop
Lupinus albus Typ Top (lupin kernel fibre, dietary fibre content: 83%)
Dietary supplement: pure fibre-product
The subjects consumed 25 g pure fibre-product per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.
Dietary supplement: reference fibre
The subjects consumed 25 g reference fibre (citrus fibre: Herbacel AQ Plus; Herbafood Ingredients) per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.
Other Names:
  • Herbacel AQ Plus
  • citrus fibre
Experimental: Soy fibre
Glycine max Hefeng (soy fibre; dietary fibre content: 77%)
Dietary supplement: pure fibre-product
The subjects consumed 25 g pure fibre-product per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.
Dietary supplement: reference fibre
The subjects consumed 25 g reference fibre (citrus fibre: Herbacel AQ Plus; Herbafood Ingredients) per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.
Other Names:
  • Herbacel AQ Plus
  • citrus fibre
Experimental: Boregine
Lupinus angustifolius Boregine (lupin kernel fibre, dietary fibre content: 87%)
Dietary supplement: pure fibre-product
The subjects consumed 25 g pure fibre-product per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.
Dietary supplement: reference fibre
The subjects consumed 25 g reference fibre (citrus fibre: Herbacel AQ Plus; Herbafood Ingredients) per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.
Other Names:
  • Herbacel AQ Plus
  • citrus fibre

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes of serum lipids (cholesterol metabolism)
Time Frame: after 2, 4 and 8 weeks
after 2, 4 and 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes of general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion
Time Frame: after 2, 4 and 8 weeks
after 2, 4 and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Gerhard Jahreis, Prof. Dr., Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

December 18, 2009

First Posted (Estimate)

December 21, 2009

Study Record Updates

Last Update Posted (Estimate)

November 6, 2012

Last Update Submitted That Met QC Criteria

November 5, 2012

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LSEP H32-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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